• FDA approves first biosimilar product Zarxio


    FDA approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

    Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

    Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen.

     

    For more information, see below:

    The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

    Biological products are generally derived from a living organism. They can come from many sources, including humans, animals, microorganisms or yeast.

    A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.

    Sandoz, Inc.’s Zarxio is biosimilar to Amgen Inc.’s Neupogen (filgrastim), which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen, and can be prescribed by a health care professional for:

    - patients with cancer receiving myelosuppressive chemotherapy;
    - patients with acute myeloid leukemia receiving induction or consolidation chemotherapy;
    - patients with cancer undergoing bone marrow transplantation;
    - patients undergoing autologous peripheral blood progenitor cell collection and therapy; and
    - patients with severe chronic neutropenia.

    “Biosimilars will provide access to important therapies for patients who need them,” said FDA Commissioner Margaret A. Hamburg, M.D. “Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.”

    The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was passed as part of the Affordable Care Act that President Obama signed into law in March 2010. The BPCI Act created an abbreviated licensure pathway for biological products shown to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product, called the “reference product.” This abbreviated licensure pathway under section 351(k) of the Public Health Service Act permits reliance on certain existing scientific knowledge about the safety and effectiveness of the reference product, and enables a biosimilar biological product to be licensed based on less than a full complement of product-specific preclinical and clinical data.

    A biosimilar product can only be approved by the FDA if it has the same mechanism(s) of action, route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product. The facilities where biosimilars are manufactured must also meet the FDA’s standards.

    The FDA’s approval of Zarxio is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Zarxio is biosimilar to Neupogen. Zarxio has been approved as biosimilar, not as an interchangeable product. Under the BPCI Act, a biological product that that has been approved as an “interchangeable” may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.

    The most common expected side effects of Zarxio are aching in the bones or muscles and redness, swelling or itching at injection site. Serious side effects may include spleen rupture; serious allergic reactions that may cause rash, shortness of breath, wheezing and/or swelling around the mouth and eyes; fast pulse and sweating; and acute respiratory distress syndrome, a lung disease that can cause shortness of breath, difficulty breathing or increase the rate of breathing.

    For this approval, the FDA has designated a placeholder nonproprietary name for this product as “filgrastim-sndz.” The provision of a placeholder nonproprietary name for this product should not be viewed as reflective of the agency’s decision on a comprehensive naming policy for biosimilar and other biological products. While the FDA has not yet issued draft guidance on how current and future biological products marketed in the United States should be named, the agency intends to do so in the near future.

    Sandoz, a Novartis company, is based in Princeton, New Jersey. Neupogen is marketed by Amgen, based in Thousand Oaks, California.

    The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

     

    Source: FDA News Release

     

  • FDA Clears Sale of First Direct-to-Consumer Genetic Test

     
    The US Food and Drug Administration (FDA) announced today that they have authorized marketing of a direct-to-consumer genetic test from 23andMe.The test is designed to identify healthy individuals who carry a gene that could cause Bloom Syndrome in their offspring.
    The agency also noted that it will now classify carrier screening tests, such as this one, as class II products, which means they are subject to general and special controls. Special controls can include performance standards, postmarket surveillance, patient registries, special labelling requirements and guidelines.
    The agency, however, specifically noted that they will not require premarket reviews for direct-to-consumer carrier screening tests. The agency plans to announce their intention of exempting these products and will have a 30-day public comment period regarding that decision.
    "The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information," said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, in the agency press release.
    "Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers.… These tests have the potential to provide people with information about possible mutations in their genes that could be passed on to their children," he said.
    Bloom Syndrome is an autosomal recessive disorder, which means that carriers may be unaware that they carry a mutation in the BLM gene, but their child could be affected. The syndrome is characterized by short stature, usually under five feet, sun sensitivity, and an increased risk for cancer.
    The syndrome is rare among the general population but is more common in the Central and Eastern European (Ashkenazi) Jewish population. In that group, approximately one in 50,000 people are affected.
     
    Labeling Requirements
     
    The agency notes that while it is not regulating who can purchase or use the tests, the company is required to provide adequate information in the label such that users will understand what the test mean, and, if sold over the counter, how they can reach a board-certified clinical molecular geneticist or equivalent for pre- and post-test counseling.
    The approval is a significant shift in direction for the agency. In November 2013, the FDA sent 23andMe a warning letter directing the company to stop selling a Personal Genome Service. The letter said the company had not obtained proper approval or demonstrated that their tests were accurate and clinically meaningful.
    In the press release today, the agency notes that two studies, involving 228 samples in a total of four laboratories, have been done to show that the Bloom Syndrome test is accurate. The company also performed usability testing to ensure that consumers could collect an adequate saliva sample.
  • THERAVECTYS Secures €1.9 Million from Bpifrance

    THERAVECTYS, a French biotech company specialized in the development of a new generation of therapeutic vaccines and immunotherapies against major global infectious diseases and cancers, announced the grant of €1.9 million from Bpifrance in the form of a repayable advance as part of the Development of Innovation Assistance program (ADI).

    With this support, Bpifrance contributes to the funding of the optimization and the upscale of the production process of lentiviral vectors as well as the conduct of regulatory preclinical studies of a therapeutic vaccine against Adult T-Cell Leukemia/Lymphoma virally-induced by HTLV-1.

    “We are delighted to benefit from the renewed confidence of Bpifrance. With this support, THERAVECTYS will be able to accelerate the optimization of its manufacturing process and the production of lentiviral vectors and T-cell therapies to be used in clinical trials. The valuable combination of our expertise and manufacturing capabilities will further strengthen THERAVECTYS’ position as a recognized leader in the space of lentiviral vectors”, said Renaud VAILLANT, Chief Executive Officer.

    Pascale PIEL, the company’s Chief Financial Officer commented on the quality of the exchanges between Bpifrance and THERAVECTYS. “Through the support of our manufacturing activities, this €1.9 million contribution will put us in a better position to successfully conduct the preclinical and Phase I/II trials related to our first vaccine candidate in oncology and against an indication of particular interest for Japan”.

    Sophie MAGNÉ, Regional Deputy Director of Bpifrance for the Greater-Paris emphasizes, “Bpifrance is a public institution with no equivalent in Europe. Our mission is to help fulfill a national priority: contributing to making France a great place for innovation and of entrepreneurs. Biotechnology is one of our top three priority, along with Digital and CleanTech. We are proud to take part in the development of THERAVECTYS, one of the most promising innovative biotech company, using a unique and novel vaccination approach.”

    Collaboration between Bpifrance and THERAVECTYS
    The long-established and trustful relationship between Bpifrance and THERAVECTYS has recently led the bank to reward the company for its growth and innovation potential and welcome Renaud VAILLANT its CEO to join Bpifrance’s Excellence Network.

    About THERAVECTYSTHERAVECTYS_Logo2

    THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.
    The company capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.
    Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.
    The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.
    Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.

    About BpiFrance bpifrance-logo
    Formed by the law of 31 December 2012, Bpifrance (a public sector investment bank) is the outcome of the merger between OSEO, the FSI, CDC Entreprises and FSI Régions. Its two shareholders are the French state and the Caisse des Dépôts bank. Its object is to support businesses (SMEs, medium-sized enterprises and larger companies of a strategic importance to the French economy), from start-up through to stock market flotation, by providing loans, guarantees and equity. Bpifrance also provides enhanced support and backing for innovation, export, and external growth. With its 42 regional offices, it is a one-stop shop for entrepreneurs in each region for all their finance and investment needs.

    Source: http://www.fortmilltimes.com/2015/01/26/3995527/theravectys-secures-19-million.html

  • Detecting lung cancer: a world 1st from a Nice University Hospital / Inserm study

    logo-chu-cancer-168x168

    A simple blood test to detect lung cancer:  this world first has been achieved through the works of Professor Paul Hofman and his team at Nice University Hospital and Inserm (Nice Sophia Antipolis University) using a test that reveals the disease years before it is visible through imaging.

    The discovery by Professor Hofman’s team goes global.

    The study was published in October in the journal PLOS ONE.  It shows for the first time that it is possible to identify the signs of cancer, in the form of “sentinel” circulating cancer cells in patients at risk of developing lung cancer, several months and even years before the cancer develops. Even if it was simply the “reassurance” given to the patient, this would be huge, however this new technique also means gaining the precious months that would be lost while waiting for the scanner’s “verdict”. This warning plays a key role in early surgical intervention, thus making it possible to attempt to eradicate the cancer. This is a major step forward in the field of modern medicine: predictive, personalised and non-invasive.

    The method was successfully tested on a group of 245 subjects without cancer.

    Prof. Hofman’s team studied a group of 245 people without cancer, including 168 patients at risk of developing lung cancer because they had had Chronic Obstructive Pulmonary Disease (COPD).  They were tested every year by ISET and low-dose CT scan. Paul Hofman and his team identified circulating cancer cells in 5 patients (3%) using the ISET test, while the CT scan did not show any nodules in the lungs. In these 5 patients, a nodule became detectable 1-4 years after the circulating cancer cells had been detected by ISET. They immediately underwent surgery and the pathological analysis of the nodule confirmed the diagnosis of lung cancer. Monitoring of the patients for a minimum of one year after surgery showed no sign of recurrence in the 5 patients.

    A first stage of the test was validated after the trials, conducted over five years: this will allow early surgery on the diseased cells and prevent many recurrences. European funds will now be used to verify these encouraging results on a larger scale with 5,000 patients.

    Early detection of lung cancer could improve the survival of millions of patients and lead to savings in healthcare.

    According to the American Cancer Society (ACS), one-year survival among these patients is 44% and 5-year survival only 16%.  Only 15% of these cancers are currently diagnosed at a stage where the disease is localised. The U.S. National Institutes of Health reports that lung cancer cost the healthcare system $12.1 billion in 2010.

    COPD is the 3rd leading cause of death in the United States and is mainly caused by smoking. Last April, an article by the prestigious New York Times reviewed all the innovative methods in predictive oncology and concluded that none of them were able to detect cancer prior to traditional imaging.

    This challenge has now been overcome for the first time through the combined action of two French teams, that of Rarecels Diagnostics which developed the test and that of Professor Paul Hofman who applied the method and conducted this study.

    International recognition for Cote d’Azur-based laboratories.

    This advance, achieved in Nice, is a proud moment for the entire Cote d’Azur scientific community and its “biology, medicine and health” sector, with its 900 researchers.

    Today, the Cote d’Azur has over 5,400 researchers and with Nice Sophia Antipolis University enjoys comprehensive, multi-disciplinary university supervision with around fifty research laboratories and some 1,300 permanent researchers. Thirty teams are involved in major research bodies such as CNRS, INSERM, Inria or the Atomic Energy Commission. From Nice to Sophia Antipolis, the Cote d’Azur features a concentration of world renowned research clusters, including 5 that, in 2012 were accredited as laboratories of excellence (labex) by the Future Investments Programme.

    The Cote d’Azur’s scientific community is no stranger to international recognition and over the last twenty years has won more than one hundred prestigious awards.

    Source:http://www.investincotedazur.com/en/info/news/detecting-lung-cancer-a-world-1st-from-a-nice-university-hospital-inserm-study/

     

     

     

     
  • French BioBeach is at CES 2015 !

    CES-Preview-2015-Android-Headlines-e1420389199453

    Stephane Richard, is present at CES 2015 to represent French BioBeach. If you want to meet Dr Richard, please don't hesitate to contact him:

    Stephane B. Richard, Ph.D. | President & Founder   Mobile: (858) 342-6807

     

    France gears up to make a big splash at CES 2015

    As reported in the fall, France will have the 2nd largest startup delegation behind the US at 66 startups and the largest European delegation overall at CES with 120 companies (France will be the 5th country overall). In fact, this year is a big one for France’s startups as the number of startups participating is up 73% over last year.  La French Tech has, of course, been making quite a bit of noise about France’s increased presence this year, kicking-off the ‘CES season’ at an invite-only launch party last month. The French administration also sees this as a critical event as Economy Minister Emmanuel Macron and Minister of State for the Digital Economy Axelle Lemaire will also be in attendance. There’s already been some great news for France’s startups, with Withings, Giroptic, Cityzen Sciences, and Lima winning CES Innovation Awards. 

    Things will get going for France’s startups tomorrow at a pitch event hosted by French-American digital strategy firm EPC Digital in partnership with the City of Las Vegas, Downtown Project, VegasTechFund and the French-American Chamber of Commerce of Los Angeles. The #FrenchPitch event will include “elevator pitch” sessions highlight innovation from French and Vegas-based staturps over a networking lunch. Thirty French startups are set to participate in the event. You can sign-up and check-out the startups participating here. 

    Following the event, participating startups, media, investors, etc will have the chance to explore and learn about Las Vegas’ burgeoning tech ecosystem, via a tour of the Downtown Project’s startup ecosystem and discussions with local startups and business leaders.

    It is positive that France is putting such a big effort behind CES year.  There’s been much debate and questions about the objective and purpose of La French Tech.  While it’s true that their still finding their footing, for me this is what La French Tech should be about – promoting France’s startups and tech ecosystem around the world and, particularly, in key markets such as the US. Hopefully collaborations with other non-French tech ecosystem players, similar to the above with VegasTechFund, will become more of the norm rather than the exception. As international expansion is increasingly priority #1 for French startups, these types of partnerships and, events such as CES in general, will be vital as they move into new markets.

    Source: http://www.rudebaguette.com/2015/01/05/french-startups-gear-make-big-splash-ces/

     

     

  • Organovo Holdings (ONVO) CEO Hints He Is Open To Selling The Company

    Organovo Holdings Inc (NYSEMKT:ONVO) was one of the top gainers Friday, climbing 15.5% after the company's CEO Keith Murphy said that he remains open to selling off the young biotech, nearly a month after it launched its first product: the exVive 3D Human Liver Tissues.

    The company’s share price skyrocketed on the CEO’s comment as speculators, looking to gain from a potential merger, started betting on Organovo. Nearly four million shares of the company exchanged hands Friday, four times the 30-day average trading volume of one million shares.

    California based organovo has pioneered aregenerative tissue technology platform to construct artificial human tissue. The company’s proprietary NovoGen 3D technology uses three-dimensional (3D) printing to generate human tissues, designed for use in transplants as well as for the discovery and development of various drugs and therapeutics. The company has started off with a focus on liver tissues under the name exVive.

    Apart from the product’s potential role in transplants, Organovo’s exVive will be particularly lucrative to big pharmaceuticals conducting research and development programs for various drug candidates. Liver toxicity is a potential side-effect associated with many experimental drugs, especially those targeting serious conditions with aggressive treatments. However, liver toxicity caused by a drug may not be detected until very late in the development stage, possibly Phase III trials, which may lead to the failure of the drug. In such a scenario, companies have to face serious repercussions in the form of wasted R&D expenditure and loss of potential future revenue.

    This may change with the availability of Organovo’s liver tissues. Using the innovative product, pharmaceuticals can test liver toxicity of a drug much earlier in its development cycle. Moreover, these 3D tissues have a life of 42 days, making them superior to currently available 2D liver tissues.

    Previously, it was expected that Organovo will likely market the product to other companies; however, the company has decided to follow a different path. It will offer other pharmaceuticals and biotechs testing services for their drugs for liver toxicity, rather than directly selling the product to them. While this may be a more sensible business for Organovo, it may have also increased its lucrativeness to other larger players who can not only benefit greatly from the liver toxicity testing option but also get a clear edge over their competitors in developing innovative drugs.

    The global pharmaceutical industry has come under considerable pressure in recent years due to high competition, price wars, slowing growth in mature markets, and patent expiration for key drugs. Most pharmaceuticals have resorted to consolidations via mega mergers or bolt-on acquisitions to add growth drivers to their portfolio.

    Companies have also put a pedal on their R&D efforts, competing to bring innovative products to the market sooner than their peers. Hence, acquisition of a smaller yet strategic target such as Organovo would make sense to many. The company’s technology would enable these large players to enhance their research efforts and also direct development expenses toward drugs with more potential.

    Mr. Murphy, in an Oppenheimer investment conference Thursday and later on CNBC, stated that he has not ruled out selling the company. The company’s stock price, which had been following a downward trajectory since the launch of exVive, shot up on expectations of a possible merger. The CEO has a near 8% stake in the company, as per a securities filing from July

    Earlier this month, Organovo signed a collaboration agreement with the Yale School of Medicine to jointly design tissues for surgical research.

    The company made its debut on the stock market in 2012 and has gained over 300% since then, with current market capitalization of $511 million. The company so far has not churned out any sales, but is expected to report $8.2 million in revenue for the current fiscal year ending March 31, 2015. Loss for the year is expected to come in at $0.29 per share.

    Last year, rumors had also surfaced that Hewlett-Packard Company (NYSE:HPQ), looking to explore the 3D printing industry, might be interested in Organovo. Other leaders in 3D printing such as 3D Systems Corporation (NYSE:DDD) and Stratasys, Ltd. (NASDAQ:SSYS) were also thought to be potential suitors. However, Organovo’s focus on medical research did not seem aligned with these big names. A larger research-focused biopharmaceutical could be a better match. However, since all of this is based on speculation, there may not be a deal soon, but the stock is expected to remain volatile amid the rumors.

  • Biotech billionaire allies with Sorrento Therapeutics

     

    Patrick Soon-Shiong is speaking on how to use "Big Data" to fight cancer. He is a biotech researcher who thinks he may have the cure for cancer.

    Biotech entrepreneur Dr. Patrick Soon-Shiong is investing in Sorrento Therapeutics as part of an alliance to develop drugs for cancer and autoimmune diseases.

    Sorrento stock closed Monday at $7.30 per share, up $1.50, or nearly 26 percent, from Friday's close.

    A company owned by Los Angeles-based Soon-Shiong will buy 19.9 percent of Sorrento's equity at $5.80 per share, Sorrento's closing price Friday. That amounts to 7,188,061 shares for a total purchase price of $41,690,754, according to a statement filed with the Securities and Exchange Commission. In addition, Soon-Shiong's company gets a 3-year warrant to purchase 1,724,138 shares at $5.80 apiece.

    Sorrento and Soon-Shiong's company will jointly invest $20 million in a joint venture to be called The Immunotherapy Antibody JV.

    Soon-Shiong is the world's richest physician, according to Forbes, worth $13.1 billion. He is investing in Sorrento through a subsidiary of NantWorks, a company Soon-Shiong founded to transform science and health care.

    Soon-Shiong outlined his health care vision in San Diego last February.

    "Combining NantWorks' cutting edge expertise in genomic and molecular profiling of cancer patients and Sorrento's industry-leading G-MAB antibody technology, we believe will enable us to develop multiple novel therapies for malignant disorders where there is currently a significant unmet need," Soon-Shiong said in a press release. "This will be a model relationship aligned to accelerate development and production of novel cancer immunotherapies. We look forward to working closely with Sorrento's team."

    Source: http://www.utsandiego.com/news/2014/dec/15/sorrento-therapeutics-soon-shiong/

     

  • Quidel Receives FDA Clearance for Its AmpliVue® Hand-Held Molecular Diagnostic Test for Bordetella Pertussis

    Quidel

    December 10, 2014 16:30 ET

    Quidel Receives FDA Clearance for Its AmpliVue® Hand-Held Molecular Diagnostic Test for Bordetella Pertussis

     

    SAN DIEGO, CA–(Marketwired – Dec 10, 2014) –  Quidel Corporation (NASDAQQDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received clearance from the United States Food and Drug Administration (FDA) to market its AmpliVue Bordetella Assay for the detection of Bordetella pertussis nucleic acids isolated from nasopharyngeal swab specimens obtained from patients suspected of having a respiratory tract infection attributable toBordetella pertussis.

    Pertussis, or whooping cough, is a very contagious disease caused by the Bordetella pertussis bacteria, which attach to the cilia that line part of the upper respiratory tract where they cause inflammation.1 Pertussis is spread from person to person through the inhalation of bacteria from an infected person's cough or sneeze. Symptoms, such as a runny nose, low-grade fever, or mild cough usually develop within 5-10 days after exposure, but sometimes appear as long as 3 weeks later. Although whooping cough can cause serious illness in children and adults, it is most dangerous for infants and babies. According to the Centers for Disease Control and Prevention (CDC), about half of infants younger than 1 year of age who get this disease require hospitalization.2

    The incidence of pertussis has risen steadily over the last few years.3 Factors that have likely contributed to the increased incidence of pertussis include a decline in vaccine use, waning vaccine-induced immunity in adolescent and adult populations, failure to receive booster shots later in life, and continued circulation of B. pertussis in our population.4-5

    The AmpliVue Bordetella Assay is an easy-to-use, self-contained, handheld disposable molecular diagnostic test with superb clinical accuracy. The assay requires no upfront extraction of DNA and generates an accurate result in approximately 75 minutes. Like all FDA-cleared AmpliVue assays, the AmpliVue Bordetella Assay is CLIA-classified6 as moderately complex and does not require the customer to invest in expensive thermocycling equipment. This benefit, plus less laboratory space requirements, can significantly lower a laboratory's cost when adopting new molecular testing methods.

    "We are pleased to receive 510(k) clearance for our AmpliVue Bordetella Assay — our fifth assay in the AmpliVue format. We've shown that we can harness our proprietary HDA technology to develop fast, accurate molecular diagnostic assays with a menu that matters to our customers," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Longer-term, we intend to leverage this technology for other molecular diagnostic applications that will be appealing to significant market segments and potentially to public health agencies worldwide."

    Quidel's AmpliVue platform now enables laboratories of all sizes to perform highly sensitive and specific molecular tests. The AmpliVue Bordetella Assay expands to six (6) the list of detectable analytes for which this novel AmpliVue platform now has FDA clearance. These include Pertussis, C. difficile, Group A Strep, Group B Strep, HSV1 and HSV2.

    1) http://www.cdc.gov/pertussis/about/causes-transmission.html  
    2) http://www.cdc.gov/pertussis/about/signs-symptoms.html 
    3) CDC. Provisional Pertussis Surveillance Report. 2013.http://www.cdc.gov/pertussis/downloads/pertussis-surveillance-report.pdf 
    4) Versteegh FGA, Schellekens JFP, Fleer A, Roord JJ. Pertussis: a concise historical review including diagnosis, incidence, clinical manifestations and the role of treatment and vaccination in management Rev Med Microbiol 2005; 16 (3): 79-89. 
    5) Atwell JE, Van Otterloo J, Zipprich J, Winter K, Harriman K, Salmon DA, Halsey NA, Omer SB. Nonmedical vaccine exemptions and pertussis in California, 2010. Pediatrics 2013; 132 (4): 624-30. 
    6) Clinical Laboratory Improvement Amendments of 1988 (CLIA). http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html?redirect=/clia/

    About Quidel Corporation

    Quidel Corporation serves to enhance the health and well being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the QuickVue®, D3® Direct Detection and Thyretain® leading brand names, as well as under the new Sofia®, AmpliVue® and Lyra brands, Quidel's products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza,respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's research and development engine is also developing a continuum of diagnostic solutions from advanced lateral-flow and direct fluorescent antibody to molecular diagnostic tests to further improve the quality of healthcare in physicians' offices and hospital and reference laboratories. For more information about Quidel's comprehensive product portfolio, visit quidel.com.

     

    SOURCE: Quidel

    This press release contains forward-looking statements within the meaning of the federal securities laws that involve material risks, assumptions and uncertainties. Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those that may be described or implied in the forward-looking statements. As such, no forward-looking statement can be guaranteed. Differences in actual results and performance may arise as a result of a number of factors including, without limitation, fluctuations in our operating results resulting from seasonality; the timing of the onset, length and severity of cold and flu seasons; government and media attention focused on influenza and the related potential impact on humans from novel influenza viruses; adverse changes in competitive conditions in domestic and international markets; the reimbursement system currently in place and future changes to that system; changes in economic conditions in our domestic and international markets; changes in sales levels as it relates to the absorption of our fixed costs; lower than anticipated market penetration of our products; the quantity of our product in our distributors' inventory or distribution channels, changes in the buying patterns of our distributors and changes in the health care market and consolidation of our customer base; our development and protection of intellectual property; our development of new technologies, products and markets; our reliance on a limited number of key distributors; our reliance on sales of our influenza diagnostics tests; our ability to manage our growth strategy, including our ability to integrate companies or technologies we have acquired or may acquire; intellectual property risks, including but not limited to, infringement litigation; limitations and covenants in our senior credit facility; that we may incur significant additional indebtedness; our need for additional funds to finance our operating needs; volatility and disruption in the global capital and credit markets; acceptance of our products among physicians and other healthcare providers; competition with other providers of diagnostic products; adverse actions or delays in new product reviews or related to currently-marketed products by the U.S. Food and Drug Administration (the "FDA"); changes in government policies; compliance with other government regulations, such as safe working conditions, manufacturing practices, environmental protection, fire hazard and disposal of hazardous substances; third-party reimbursement policies; our ability to meet demand for our products; interruptions in our supply of raw materials; product defects; business risks not covered by insurance and exposure to other litigation claims; interruption to our computer systems; competition for and loss of management and key personnel; international risks, including but not limited to, compliance with product registration requirements, exposure to currency exchange fluctuations and foreign currency exchange risk sharing arrangements, longer payment cycles, lower selling prices and greater difficulty in collecting accounts receivable, reduced protection of intellectual property rights, political and economic instability, taxes, and diversion of lower priced international products into US markets; volatility in our stock price; dilution resulting from future sales of our equity; and provisions in our charter documents and Delaware law that might delay stockholder actions with respect to business combinations or the election of directors. Forward-looking statements typically are identified by the use of terms such as "may," "will," "should," "might," "expect," "anticipate," "estimate," "plan," "intend," "goal," "project," "strategy," "future," and similar words, although some forward-looking statements are expressed differently. The risks described in reports and registration statements that we file with the Securities and Exchange Commission (the "SEC") from time to time should be carefully considered. You are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date of this press release. We undertake no obligation to publicly release the results of any revision or update of these forward-looking statements, except as required by law.

     
  • San Diego to lead in economic growth

     

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    San Diego will lead an economic expansion across California and the nation in 2015, says an economic forecast released Friday by Point Loma Nazarene University.

    "This is an economy that I think is finally taking up some speed," said Lynn Reaser, the chief economist at Point Loma Nazarene's Fermanian Business and Economic Institute. "As I talk to consumers and go into restaurants and shops and businesses, there seems to be finally some more optimism. People are finally believing, 'Yes, the recession is over,' and it’s not just for economists, it’s for them."

    Speaking to several hundred people at the Hyatt Regency La Jolla on Friday, Reaser said she was bullish on San Diego's economy and the job market for the upcoming year.

    Reaser said San Diego's leading edge biotech field is on fire, while other technological firms making unmanned aerial vehicles, and those in environmental science and health care continue to grow. Those, combined with large defense and tourism sectors put San Diego on a path to add 35,000 jobs, the most since 2012. That should push the unemployment rate down to 5.4 percent by the end of the year.

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    Lynn Reaser, economist, Point Loma Nazarene University. Photo Courtesy of: Point Loma Nazarene University

    "San Diego looks like it's going to outperform everybody," Reaser said. "We're going to outperform the state and we’re going to outperform the nation as whole."

    That's not to say the state and the nation won't see progress in 2015. Reaser pointed to a positive national jobs report released Friday by the U.S. Bureau of Labor Statistics, showing 321,000 people added to payrolls in November and the unemployment rate at 5.8 percent. She also noted that wages grew 2.1 percent annually, which is a reflection of a positive job market.

    Overall, she expects consumers to continue spend more and save less. She said a recovery in the global economy could cause oil prices to tick up to $80 a barrel, but that low gas prices still represent a tax cut for consumers. She noted that every penny saved on gas is an extra $1 billion to spend. As a whole, she said inflation will stay around 2 percent, not too hot and not too cold.

    Reaser said she expects businesses across the country to invest more in equipment and technology, and that will help push the national gross domestic product up to 3 percent.

    "We’ve seen growth just at about an average of 2.3 percent," Reaser said. "That is really sad and really anemic, and we think we’ll finally break out of that zone in 2015."

    Statewide, Reaser said California has done quite well, and expects 325,000 year-over-year job gains to be added in 2015. That would push the state's jobless rate down to 6.5 percent, about 1 percent higher than the national average.

    Reaser said she considers the biggest threat to the nation's economy to be the Islamic State, and also urged business to invest in guarding against cyber attacks.

    Point Loma Nazarene gave itself a 'B' grade for last year's forecast.

    The university correctly predicted that the Federal Reserve would scale back its quantitative easing, but the central bank did it sooner than expected. Inflation remained slow, at 1.7 percent, exactly what the university predicted. Point Loma Nazarene predicted California would add 265,000 payroll jobs in 2014, but the state has added 302,000 jobs. The university correctly predicted the state's unemployment rate would drop more than a full percent.

    San Diego and the nation both added more jobs than the school anticipated. Locally, employers added about 34,000 jobs this year, above the 28,000 PLNU had predicted. Nationwide, employers added 2.7 million jobs, above the 2.4 million the school anticipated.

    The county’s housing market improved differently than Point Loma Nazarene forecast last year. Home price appreciation slowed from 18 percent in 2013 to 4 percent in 2014. The university estimated home prices to grow 9 percent over the year. Reaser said, however, that building activity increased more than anticipated.

    SOURCE: http://www.utsandiego.com/news/2014/dec/05/point-loma-nazarene-economic-forecast-jobs-gdp/

  • BioNano Genomics Raises $53 Million Series C to Advance Genomic Mapping Technology to Reach the “Inaccessible Genome”

    SAN DIEGONov. 20, 2014 /PRNewswire/ – BioNano Genomics, Inc., the leader in genome mapping, announced today the completion of a $53 million Series C financing.  Legend Capital and Novartis Venture Fund co-led the round and were joined by Federated Kaufmann Fund and Monashee Investment Management as new investors. Existing investors Domain Associates, Battelle Ventures and Gund Investment Corporation also participated.  Darren Cai, Ph.D., Executive Director at Legend Capital, and Campbell Murray, M.D., Managing Director at Novartis Venture Fund, joined BioNano’s board of directors.  The capital raised will be used to expand commercialization efforts to grow the installed base and utilization of BioNano’s Irys™ platform and to develop the next generation platforms and technology innovations.

    “BioNano’s Irys System enables comprehensive detection of structural variations (SVs), which makes up a substantial portion of genome differences among individuals.  The ability to robustly discover SVs is recognized as an essential tool for applications of genomic information in personalized medicine and diagnostics,” said Dr. Cai.  “We see genome mapping as a large, high-growth market that complements and broadens the sequencing market.”

    Implicated in a rapidly growing list of clinical indications, SVs are fundamental to understanding, diagnosing and treating many human diseases; they also play significant roles in the understanding of food crops and other areas of ag-bio  Structural variations include insertions, deletions, inversions, translocations and repeats.  As a whole, they have been termed the “inaccessible genome,” because they are often missed by the existing repertoire of genomics tools.

    Dr. Murray stated, “We saw that BioNano has the only commercial genome mapping system that can systematically analyze clinically important SVs, including DNA rearrangements and recombinations, and were inspired  to provide capital and expertise to BioNano.”

    “Understanding structural variation is essential to advancing the clinical impact and diagnostic use of genomics,” said Tracy Warren, Board Chair of BioNano Genomics.  “BioNano’s Irys System offers the missing link between sequencing data and actionable clinical data.”

    BioNano’s Irys System is a long-read genome mapping solution that reveals the location, order and orientation of functionally relevant components of the genome, including the size and location of long repeats and integration sites, which are often implicated in complex diseases such as cancer.  Irys finds all types of structural variations in a single assay, without prior knowledge of the variants.  Previously, obtaining a comprehensive view of a genome was a major hurdle because existing tools such as next generation sequencing and arrays do not provide the scalability or reliability to detect, resolve and assemble large repetitive elements and structural variations.

    “Our investors have seen the research community’s response to BioNano’s Irys System as a ‘must have’ instrument to drive the next wave of discoveries in genomics. They foresee how our technology will enable the practical use of genomic information in the clinic and in other important industrial settings,” said Erik Holmlin, Ph.D., President and CEO of BioNano.  “We will use this capital to accelerate global sales of Irys and to invest in next generation innovation to address the untapped, multi-billion dollar genome mapping market.”

    About Legend Capital

    Legend Capital is an investment company focusing on innovation and growth, with its core business oriented toward growth investment at the expansion stage as well as venture investment.  Legend Capital manages assets of more than $3 billion across 9 funds and has invested in more than 200 companies.  Legend has an investment team of more than 50 professionals, including 20 partners.  http://www.legendcapital.com.cn/en/

    About Novartis Venture Fund

    The Novartis Venture Fund (NVF) manages over $1 billion in committed capital and more than 45 portfolio companies.  NVF invests in companies with the potential to change a core therapeutic field or explore new business areas that will be critical to patient care. Our primary interest is in the development of novel therapeutics and platforms as well as medical devices and diagnostics. NVF is an independent and financially driven corporate venture fund with offices in Basel, Switzerland and Cambridge, Massachusetts. http://www.venturefund.novartis.com.

    About Federated Kaufmann Fund

    Federated Kaufmann Fund is a publicly traded mutual fund with approximately $5.6 billion in assets.  Federated Kaufmann Fund is part of Federated Investors, Inc., a leading global investment manager with approximately $350 billion in assets.

    About Monashee Investment Management

    Monashee Investment Management is an investment advisor located in Boston, Massachusetts.

    About BioNano Genomics

    Headquartered in San Diego, BioNano Genomics is delivering an altogether better way of gaining a fully informed understanding of genomes. BioNano is the only company that offers a systematic and commercially viable approach to detect the long-range genomic information that reveals the structure of complex genomes, such as human and cancer.  Structural variations are increasingly known for being inextricably tied to human diseases and therefore are vital to their diagnosis and treatment.  The Company’s Irys platform provides researchers and clinicians with the most comprehensive, organized and actionable picture of a genome, including unprecedented insights into how the individual components of genomes are ordered, arranged, and interact with each other. BioNano Genomics works with institutions in life science, translational research, molecular diagnostics and personalized medicine. The Company is supported by Legend Capital, Novartis Venture Fund, Federated Kaufmann Fund, Monashee Investment Management, Domain Associates, Battelle Ventures and Gund Investment as well as grant funding from genomics programs at federal agencies, including the NIH and NIST-ATP.

    http://www.BioNanoGenomics.com

    Notes: BioNano Genomics is a trademark of BioNano Genomics, Inc. Any other names of actual companies, organizations, entities, products or services may be the trademarks of their respective owners.

    SOURCE http://www.prnewswire.com/news-releases/bionano-genomics-raises-53-million-series-c-to-advance-genomic-mapping-technology-to-reach-the-inaccessible-genome-283322391.html