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 RequirementsThe 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, 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.
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.
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.
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.
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.
Organovo shares climbed over 15% Friday after CEO Keith Murphy said he won’t rule out 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.
Quidel Receives FDA Clearance for Its AmpliVue® Hand-Held Molecular Diagnostic Test for Bordetella Pertussis
Quidel Receives FDA Clearance for Its AmpliVue® Hand-Held Molecular Diagnostic Test for Bordetella Pertussis
BioNano Genomics Raises $53 Million Series C to Advance Genomic Mapping Technology to Reach the “Inaccessible Genome”
SAN DIEGO, Nov. 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.
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.
“California leads the nation in the biomedical industry, supporting highly skilled and well-paying jobs in communities across the state.” – California Governor Jerry Brown
Palo Alto, Calif. (PRWEB) November 20, 2014
The California Healthcare Institute (CHI), a nonprofit, public policy research organization representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms, and PwC US today released a report revealing that California trumps other states in life sciences industry growth. The trend shows a 4 percent increase between 2009 and 2013. The 2015 California Biomedical Industry Report indicates that, while biopharmaceutical and medical device employment in top-ranked biotech states such as New Jersey, New York and Pennsylvania has decreased in recent years, employment in California is growing. In fact, California employment in the life sciences has surpassed that of other major state industries, such as aerospace, electronic equipment manufacturing, telecommunications and data processing.
“California leads the nation in the biomedical industry, supporting highly skilled and well-paying jobs in communities across the state,” said California Governor Jerry Brown. “I look forward to continuing to work with leaders from companies and research institutions throughout the state to find solutions that advance new medical technologies, strengthen our economy and contribute to a healthier society.”
“The life sciences sector continues to drive our state’s 21st century economy,” said Todd E. Gillenwater, President and CEO of CHI. “270,000 Californians are employed by over 2,600 companies, with average wages topping $100,000. It is no coincidence that California is also home to 11 of the world’s top universities and that we garner more federal biomedical research dollars than any other state in the nation. No other state or nation has what we have here in California, but they want it. We must work actively to ensure that California maintains an environment that fosters biomedical research, investment and job creation.”
The report is published annually to provide factual insight into the state of California’s biomedical industry and to identify key trends. Noteworthy findings this year:
California life sciences companies generated $101 billion in revenue in 2013.
California scientists received $3.3 billion in NIH research grants in federal fiscal year 2014.
The industry paid workers $27.4 billion in salaries and wages during 2013.
California has 2,636 life sciences companies in 2014.
$3.8 billion in life sciences venture capital is projected to be invested in California companies in 2014.
California companies have 1,205 new medicines in the development pipeline.
“This latest report once again emphasizes the importance of California’s more than 2,600 life sciences companies in driving innovation and development in this critical healthcare space,” said Peter Claude, Partner, PwC. “The research shows that California companies and innovators continue to be sought after by those looking to support and fund advances in healthcare, which benefits patients and populations everywhere.”
Education is credited as the foundation for California’s thriving biomedical industry, promising the opportunity to advance the industry through a highly educated workforce. Of the top 100 schools in the world, 11 are located in California. The National Institutes of Health (NIH) awarded more than $3 billion in funding to California institutions in 2013. Academics anticipate that grants awarded in 2014 will be increased to nearly $3.3 billion.
Click here for more information and to view the full report.
About CHI-California Healthcare Institute
CHI represents more than 275 leading biotechnology, medical device, diagnostics and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance biomedical research, investment, and innovation through effective advocacy of policies to improve public health and ensure the continued vitality of the life sciences sector. CHI’s website is http://www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.
About PwC’s Pharmaceutical and Life Sciences Industry Group
PwC’s Pharmaceutical and Life Sciences Industry group is dedicated to delivering effective solutions to the complex strategic, operational, and financial challenges facing pharmaceutical, biotechnology, and medical device companies. We provide industry-focused assurance, tax, and advisory services to build public trust and enhance value for our clients and their stakeholders. For more information visit: http://www.pwc.com/us/pharma and http://www.pwc.com/us/medtech.
Contact: Will Zasadny California Healthcare Institute Zasadny(at)chi(dot)org (619) 961-8848
Tony Herrling Brainerd Communicators, Inc. herrling(at)braincomm(dot)com (212) 986-6667