Medical Device Link The Online Information Source for the Medical Device Industry.

Millipore Corp. reported financial results for its third quarter ended October 3, 2009. Revenues for the third quarter grew 4% from the previous year, totaling $412 million. Excluding a 3% unfavorable impact from changes in foreign currency, Millipore generated organic revenue growth of 7%. On a divisional basis, excluding changes in foreign currency, Millipore’s bioprocess division generated organic revenue growth of 8%, while the company’s bioscience division generated organic revenue growth of 4% from the previous year.

Millipore’s third quarter earnings per share were $0.71 per share, compared to $0.68 per share in the third quarter of 2008. Non-GAAP earnings per share were $0.95, compared to $0.93 per share in the third quarter of 2008. A reconciliation of GAAP to non-GAAP financial measures is provided in the Company’s financial tables accompanying this press release.

Meanwhile, Nanosphere Inc. also reported financial results for the third quarter and nine months ended September 30, 2009. Total revenue for the third quarter of 2009 was $729,000 compared with total revenue of $283,000 for the third quarter 2008 and $402,000 in the second quarter of 2009. Net loss for the third quarter of 2009 was $8.2 million as compared to $9.0 million for the third quarter of 2008. Cash on hand at the end of the third quarter of 2009 was $50.3 million. For the nine months ended September 30, 2009, total revenue was $1.4 million compared to $1.1 million for the same period last year.

Genomic Health Inc. reported financial results and business progress for the quarter ended September 30, 2009. Total revenue increased to $39.5 million in the third quarter of 2009 compared with $28.1 million in the third quarter of 2008. Product revenue from the Oncotype DX breast cancer test was $38.9 million in the third quarter of 2009, an increase of 39%, compared with $28.1 million in the third quarter of 2008.

Net loss decreased to $502,000 in the third quarter of 2009 from $3.0 million in the third quarter of 2008. Basic and diluted net loss per share was $0.02 in the third quarter of 2009, compared with basic and diluted net loss per share of $0.11 in the third quarter of 2008.

Cash and cash equivalents and short-term investments at September 30, 2009 were $58.9 million, compared with $55.7 million at June 30, 2009 and $56.7 million at December 31, 2008.

Bio-Rad Laboratories Inc. announced that for the third quarter ended September 30, 2009, revenues were $461.1 million, up 4.4% compared to $441.8 million reported for the third quarter of 2008. On a currency-neutral basis, quarterly revenues increased 11.1% compared to the same period last year. This improvement is primarily the result of organic growth across a range of products in Bio-Rad’s two main areas, life science and clinical diagnostics, as well as the additional revenue generated from the purchase of certain DiaMed distributors since the third quarter of 2008.

Net income attributable to Bio-Rad for the third quarter was $38.5 million, or $1.38 per share on a fully diluted basis, compared to $27.8 million or $1.00 per share, respectively, during the same period last year. Third-quarter gross margin increased to 56.5% compared to 54.4% during the same quarter last year.

Year-to-date revenues were $1.3 billion, down 2.1% compared to the first three quarters in 2008. Adjusting for the impact of currency effects, revenue growth was 5.9%. Year-to-date net income attributable to Bio-Rad for 2009 was $106.8 million, or $3.85 per share on a fully diluted basis, compared to $97.7 million, or $3.54 per share, respectively, during the same period in 2008.

Bio-Rad’s clinical diagnostics segment reported net sales of $307.5 million for the third quarter, up 9.3% compared to the third quarter in 2008. On a currency-neutral basis, sales for the segment increased 17.8%. These gains are the result of strong sales across a number of product lines, including blood virus testing products, quality control products, and the company’s BioPlex 2200 system. The segment also benefited from additional revenue resulting from the purchase of certain DiaMed European distributors in the fourth quarter of 2008, as well as the purchase of the DiaMed distributor in India in the second quarter of this year.

BD (Becton, Dickinson and Company) also reported quarterly revenues of $1.898 billion for the fourth fiscal quarter ended September 30, 2009, representing an increase of 5% from the prior-year period, or 8% excluding the unfavorable impact from foreign currency translation. For the full fiscal year ended September 30, 2009, BD reported revenues of $7.161 billion, representing an increase of 1% over the prior year, or 5% excluding the unfavorable impact from foreign currency translation.

On-Q-ity (Waltham, MA), a next-generation oncology IVD company focused on improving cancer therapy effectiveness, announced that it has closed a $21 million series A financing. The funding was led by MDV-Mohr Davidow Ventures and included Bessemer Venture Partners, Physic Ventures and Northgate Capital.

On-Q-ity is developing IVDs to determine optimal treatment choice for cancer patients at each stage of the treatment cycle, from the first therapy choice to monitoring for recurrence. The company’s novel circulating tumor cell (CTC) technology and predictive biomarker platform allows for the analysis of tumor tissue samples as well as capture of rare tumors cells that are circulating in a cancer patient’s blood. Those cells are then monitored for molecular changes that are characteristic of therapy response. This combination enables minimally invasive real-time data on a patient’s status, allowing treatment adjustments before changes are visible with any other technology.

FDA published a guidance document that should help IVD manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, IVD manufacturers can submit a request to FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national public health emergency declared by Department of Health and Human Services Secretary Kathleen Sebelius in April. This guidance document outlines what information FDA recommends that IVD manufacturers include in these EUA requests.

The EUA authority allows FDA to authorize use of unapproved or uncleared medical products or unapproved or uncleared uses of approved or cleared medical products following a declaration of emergency, when certain criteria are met. The authorization ends when the declaration of emergency is terminated or the authorization is revoked by FDA.

While FDA encourages IVD manufacturers to submit appropriate premarket applications for these tests, the agency also recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application. However, this guidance outlines information FDA recommends be included, and FDA gives these requests thorough and careful review to protect the public health.

During this declared public health emergency, IVD manufacturers of 2009 H1N1 influenza virus tests that are unable to submit a complete premarket notification may use the guidance to submit a request for an EUA.

The guidance document is part of FDA’s ongoing efforts to provide public health authorities managing the pandemic with reliable and accessible diagnostic tests. The guidance is available by clicking here, and will remain in effect throughout the public health emergency.

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.

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.

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.

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.

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.