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Archive for October, 2009

Nanosphere Prices Stock Offering to Raise $30M

Friday, October 16th, 2009

Nanosphere Inc. announced the pricing of its previously announced underwritten public offering of 4,700,000 shares of its common stock at a public offering price of $7.00 per share. In connection with the offering, the company has also granted the underwriter a 30-day option to purchase up to an additional 705,000 shares of common stock to cover over-allotments, if any. Piper Jaffray & Co. acted as the sole manager for the offering.

Net proceeds from the sale of the shares after underwriting discounts and commissions and other offering expenses are expected to be approximately $30.6 million. If the underwriter exercises its over-allotment option in full, net proceeds from the offering will be approximately $35.3 million. The offering is subject to customary closing conditions and is expected to close on Wednesday, October 21, 2009. The company plans to use the net proceeds from the offering for general corporate purposes and working capital.

Tags: Finance
Posted in Business News | No Comments »

Illumina Countersues Life Technologies for Patent Infringement

Thursday, October 15th, 2009

Illumina Inc. announced that, together with Solexa its wholly owned subsidiary, it has filed its initial response to the lawsuit brought by Life Technologies and Applied Biosystems on September 21, 2009 in U.S. District Court in Wilmington, Delaware. In their answer, Illumina and Solexa have denied all of Life’s and AB’s allegations of patent infringement, and have asserted that AB’s licensed patents are invalid. In their counterclaims, Illumina and Solexa have sued Life and AB for infringement of four Solexa patents by Life’s SOLiD sequencing system. These four patents (U.S. Patent Nos. 6,831,994; 6,654,505; 7,232,656; and 7,598,035 having expiration dates falling between December 2017 and July 2019), stem from three different patent families and are applicable to various aspects of the SOLiD system, specifically sample preparation, data gathering and genome analysis. As remedy, Illumina seeks: a permanent injunction against further sales of the SOLiD system, the destruction of infringing SOLiD system products, and damages for Life and AB’s infringement of these four patents.

Tags: Litigation
Posted in Business News, Molecular Diagnostics | No Comments »

Leroy Hood Launches Personalized IVDs Company

Wednesday, October 14th, 2009

Integrated Diagnostics launched officially today with more than $30 million in funding. A team of scientists and investors are behind the company, which was founded by renowned biotechnology innovator Leroy Hood. Integrated Diagnostics will focus on developing personalized and preventive diagnostics based on breakthroughs using genomic and proteomic technologies to identify organ-specific proteins. The company will be developing diagnostic tools to help patients and physicians detect disease in its earliest stages. Building on research from Hood, Jim Heath, and other scientists, Integrated Diagnostics is creating diagnostic tools and innovative biomarkers that will help define the coming transition to health care that is predictive, preventive, personalized, and participatory.

Integrated Diagnostics will have access to Hood’s research at Institute for Systems Biology (ISB) investigating protein blood markers that can report on the physiological state of the body’s 50 major organs. His research uses genomic and proteomic techniques to identify blood proteins that are only synthesized in the organ of interest and then identifies subtle changes that result from disease or treatment. By monitoring concentrations of these proteins in the blood, disruptions in healthy function can be detected and traced back to the diseased organ. This work is based on the concept of a systems view of disease where pathophysiology arises from disease-perturbed networks of proteins, genes, and other molecules.

Through its research collaborations, Integrated Diagnostics possesses proprietary data on organ-specific proteins across a range of human organs. These protein panels are applicable to many diagnostic modalities including early detection of disease, stratification of disease types, and monitoring disease progression and recurrence. The company’s technology is applicable to a broad scope of diseases, including cancer, diabetes, and Alzheimer’s disease.

InterWest Partners, a diversified venture capital firm, led the $30 million Series A financing for Integrated Diagnostics and was joined by The Wellcome Trust and dievini Hopp Biotech holding. dievini’s participation in the Series A financing is part of a collaboration with the Grand Duchy of Luxembourg, which plans to become part of the investor group in the future. Integrated Diagnostics is the first commercial enterprise to emerge from a unique $200 million public-private partnership, announced in 2008, between the nation of Luxembourg and three American research institutions, including ISB. As part of the investment, Integrated Diagnostics will have access to research from the ongoing research collaboration in systems biology between Luxembourg and ISB, which also involves the development of the Luxembourg Centre for Systems Biomedicine.

Click here to access IVD Technology’s exclusive interview with Leroy Hood.

Tags: Collaboration, Finance
Posted in Business News, Personalized Medicine | No Comments »

Smiths Detection Awarded Grants

Tuesday, October 13th, 2009

Smiths Detection announced the award of a $2.2m, two-year grant from the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health (NIH), to develop a test for multiple types of influenza. The test will run on Smiths Detection’s Clinical Bio-Seeq instrument.

The test developed under this program will be designed to diagnose disease in humans and will be suitable for use in a conventional laboratory setting or in a point-of-care setting running on the company’s own clinical Bio-Seeq instrument. A similar test, developed by Smiths Detection outside the NIH grant program, will also be made available for diagnosing influenza infections in animals, including potential pandemic strains. The animal test will run on both desk top and field portable versions of the Bio-Seeq. Development of the field portable version is complete, and the desk top clinical diagnostic version will shortly enter clinical trials.

Smiths Detection also announced the award of a $1m, two-year grant from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) to develop a rapid test for eight micro-organisms that commonly cause burn/wound infections leading to septicemia (blood-poisoning). The test will also run on Smiths Detection’s Clinical Bio-Seeq System.

Under this grant, Smiths Detection will expand its collaboration with the University of California, Davis – Lawrence Livermore National Laboratory (LLNL) Point-of-Care (POC) Technologies Center, which focuses on pathogen detection for critical, emergency, and disaster care, Validation of the assay, as well as evaluation of the performance of Bio-Seeq in an ICU setting, will be conducted at the UC Davis Medical Center.

Development of this highly multiplexed test will be achieved by using Smiths Detection’s LATE PCR nucleic acid amplification and detection technology. This technology was licensed from Brandeis University, which will also support the project. The test will also be suitable for use in a conventional laboratory setting or in a point-of-care setting running on the company’s Clinical Bio-Seeq instrument.

Tags: Grants
Posted in Business News, Molecular Diagnostics | No Comments »

Orion Genomics, Novartis Collaborate on Personalized Medicine

Monday, October 12th, 2009

Orion Genomics has entered into a multiyear collaboration and license agreement with the molecular diagnostics unit of Novartis Pharma AG. Under the collaboration, the parties seek to discover novel epigenetic biomarkers, and both parties have rights to independently develop and commercialize diagnostic products in their respective fields. Under the terms of the agreement, Orion Genomics also grants Novartis nonexclusive worldwide rights to its proprietary MethylScreen clinical assay technology. Financial terms were not disclosed.

The collaboration will leverage Orion Genomics’ MethylScope Technology to build high-resolution genome-wide DNA methylation maps for the discovery of epigenetic biomarkers in multiple disease fields. Novartis also obtains a nonexclusive license to MethylScreen Technology, Orion’s PCR-based clinical assay platform that quantitatively detects epigenetic biomarkers in patient samples. Under the agreement, Orion and Novartis intend to develop and commercialize promising diagnostic products that address various stages of disease. Resulting diagnostic tests could lead to advances in personalized medicine, potentially helping doctors optimize the treatment of patients.

Tags: Collaboration
Posted in Business News, Personalized Medicine | No Comments »

Transgenomic Licenses PCR Technology from Dana-Farber

Friday, October 9th, 2009

Transgenomic Inc. has licensed a high-sensitivity mutation detection technology called Cold-PCR from the Dana-Farber Cancer Institute (DFCI). This variation of the standard PCR technology enriches mutations in DNA samples and is a much more sensitive technique for finding low level mutations in tissue and body fluids that are involved with a variety of diseases. Cold-PCR was invented at DFCI by Mike Makrigiorgos who has demonstrated its effectiveness in enriching for mutations in cancer-related genes in samples where standard DNA sequencing is not sensitive enough to detect these very low concentration somatic DNA mutations. The licensing terms include exclusive rights to commercialize Cold-PCR technology combined with Sanger sequencing as well as all applications for mitochondrial DNA analysis.

Cold-PCR will have applicability in detection of cancer-related mutations where critical mutations are present at a very low percentage compared to normal DNA. Examples would be in blood and urine or where the tissue collected contains mostly normal cells. This would allow clinicians to use less intrusive methods for genetic analysis or allow more efficient use of tumor tissue samples. Additionally the method could enhance the detection of the emergence of cancer drug resistance mutations, allowing early detection of relapse.

Tags: Cancer
Posted in Business News | No Comments »

Senators Oppose IVD Tax

Thursday, October 8th, 2009

Stephen J. Ubl, president and CEO of AdvaMed, issued the following statement regarding growing bipartisan opposition to the proposed $40 billion tax on medical devices and IVDs:

“A group of 14 Democratic Senators expressed their deep concerns about the damaging impact of the proposed $40 billion tax on medical devices. As they write in their letter, ‘We are extremely concerned that this tax could threaten jobs in our states, reduce domestic investment in research and development, and ultimately diminish access to life-saving medical devices for patients.’

“The 14 Senators who sent the letter are: Sen. Evan Bayh, Sen. Amy Klobuchar, Sen. Sherrod Brown, Sen. John F. Kerry, Sen. Ben Nelson, Sen. Kay R. Hagan, Sen. Al Franken, Sen. Paul G. Kirk, Jr., Sen. Dianne Feinstein, Sen. Debbie Stabenow, Sen. Barbara Boxer, Sen. Kirsten E. Gillibrand, Sen. Robert Menendez and Sen. Frank R. Lautenberg.

“The letter is just the latest in the significant opposition to this tax. Recently, the Governors of Utah, California, Nevada, Indiana, and Minnesota expressed opposition as well as 20 Democratic Members of the U.S. House of Representatives, and more than 40 organizations among many others. These leaders share the concerns of the nearly 360,000 men and women who make up the device and diagnostics industry and whose efforts have made the United States the world’s leader in the development of innovative, life-saving medical technology.”

Click here to access the letter.

Posted in Government Affairs | No Comments »

Gen-Probe Acquires Prodesse

Wednesday, October 7th, 2009

Gen-Probe Inc. has signed a definitive agreement to acquire Prodesse Inc., a privately held company producing molecular testing for influenza and other infectious diseases, for approximately $60 million in cash. Gen-Probe’s purchase price could increase to up to $85 million if Prodesse achieves certain financial and regulatory milestones in 2010 and 2011.

In connection with the acquisition, Gen-Probe and Prodesse have signed an agreement under which Gen-Probe’s sales representatives in the United States, Canada, and Europe will begin copromoting Prodesse’s products in mid-October.

Both companies’ boards of directors have unanimously approved the transaction, and the Prodesse shareholder votes necessary to approve the transaction have already been obtained. The transaction is expected to close within a month, subject to customary conditions.

Tags: Gen-Probe, Merger & Acquisition
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U.S. Attorney, Nasdaq Launch Investigation into Sequenom

Tuesday, October 6th, 2009

In a filing with the U.S. Securities and Exchange Commission, Sequenom Inc. made the following statement:

“Following our announcement on September 28, 2009 regarding the completion of the independent investigation by the special committee of our board of directors, representatives of Nasdaq and the Office of the U.S. Attorney for the Southern District of California separately contacted us to inquire about our announcement. We intend to cooperate fully with Nasdaq and with the U.S. Attorney. We have met with representatives of the U.S. Attorney and the Federal Bureau of Investigation in connection with their investigations. In addition, members of the special committee and its independent counsel have met with the Enforcement Staff of the Securities and Exchange Commission in connection with its investigation.”

Last week, Sequenom terminated the employment of its president and chief executive officer, Harry Stylli, PhD, and its senior vice president of research and development, Elizabeth Dragon, PhD, upon completion of an investigation into mishandled test data and results for the company’s noninvasive prenatal test for Down syndrome. Click here for more information.

Posted in Business News, Government Affairs | No Comments »

FDA Awards Biosearch Technologies $3.4M Contract for Pathogen Detection

Monday, October 5th, 2009

Biosearch Technologies Inc. has been awarded a contract by FDA for the development of rapid multiplexed fluorescent assays to determine bioterror and food safety pathogens. This five year contract utilizes bead-based assays and detection on a Luminex xMap platform. Throughout the contract, Biosearch will be collaborating with Pejman Naraghi-Arani, PhD, at Lawrence Livermore National Laboratories (LLNL), and Luminex Corp. to develop rapid, highly specific assays for agents listed as select agents by CDC and the U.S. Department of Agriculture (USDA). Naraghi-Arani is a thrust area leader in the Biological Detection and Response Program at LLNL, and serves as the contract’s technical expert. The initial target analytes include Bacillus anthracis, the causative agent of anthrax; Yersinia pestis, the causative agent of the plague; and Francisella tularensis, the causative agent of tularemia. Each of the three pathogens is listed as a category A priority pathogens by the National Institute of Allergy and Infectious Diseases.

Tags: Biodefense, Collaboration, FDA
Posted in Business News, Government Affairs | No Comments »