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In Vitro Diagnostic Technlogy Blog
 

Archive for August, 2009

Affymetrix, Beckman Coulter Form Partnership

Wednesday, August 26th, 2009

Affymetrix Inc. and Beckman Coulter Inc. have entered into an agreement to offer researchers codeveloped products from the market leaders in microarrays and automated liquid handlers. The collaboration will provide scientists with optimized, robust solutions for genomic research, fortified by end-to-end support.

The partnership will yield an expanding list of Affymetrix-validated automated target preparation methods, developed on an Affymetrix-specific configuration of Beckman Coulter’s Biomek FXp Dual Arm Multichannel–Span 8 Liquid Handler. This platform will provide researchers with standardized systems that include all components necessary to run Affymetrix genotyping and gene expression assays.

Major benefits of the solution will include the flexibility to process samples using Affymetrix GeneChip Arrays or Array Plates with a single method, user-friendly interfaces, rapid implementation of new methods, a validated platform, elimination of costly mistakes, and delivery of high-quality results.

AMDL Launches IVD Subsidiary

Monday, August 24th, 2009

AMDL Inc. announced the inauguration of AMDL Diagnostics Inc. (ADI), a new wholly‐owned subsidiary that will focus on the research, development, manufacture, and international sales of Onko‐Sure, AMDL’s proprietary, regulatory approved IVD cancer test.

The establishment of a separate subsidiary allows AMDL to concentrate specific resources to the successful execution of that plan. ADI intends to achieve goals set forth in its 5‐year plan by securing adequate financing, significantly broadening its distribution network, and continuing to research, develop, and commercialize current and future diagnostic products. ADI’s management believes sales of Onko‐Sure test kits are likely to exceed $100 million per year by the end of FY2014. Current projections for ADI indicate FY2009 sales of approximately $1 million and generating a small loss for the year, and sales of approximately $17 million with over $13 million in earnings in FY2010.

Rosetta Genomics Reaches Assay Distribution Agreement in India, Middle East

Thursday, August 20th, 2009

Rosetta Genomics Ltd. (Philadelphia), a developer of microRNA-based molecular diagnostics, and Super Religare Laboratories Limited (SRL; New Dehli), India’s largest diagnostics network, announced that they have signed an exclusive distribution agreement for Rosetta Genomics’ three currently-available diagnostic tests. Under the terms of the agreement, SRL will market Rosetta Genomics’ miRview tests in India, Saudi Arabia, Qatar, and the United Arab Emirates. Samples will be sent from SRL’s territories to Rosetta Genomics’ Philadelphia-based CLIA-certified laboratory for analysis. The terms of the deal were not disclosed. The two companies have also discussed the possibility to expand their relationship into research and development projects.

AdvanDx Secures $8 Million Financing

Tuesday, August 18th, 2009

AdvanDx has closed another $8 million in financing from existing stockholders, SLS Venture and LD Pensions. The additional investment is part of a series C round of financing, the first part of which was closed in September 2007, and will be used to fund the expansion of AdvanDx’s molecular diagnostics product offering as well as its international sales and marketing activities.

In addition to the financing, stockholders elected Tina W. Christensen to the AdvanDx board of directors. She is a vice president and chief financial officer at the Danish health insurance company danmark, which specializes in providing 2 million Danish citizens with supplemental health insurance to the Danish National Health Service.

Beckman Coulter Launches Genomic Services Unit

Wednesday, August 12th, 2009

Beckman Coulter Inc. announced the creation of Beckman Coulter Genomics. The new company, which combines Agencourt Bioscience and the newly acquired Cogenics, offers researchers a single genomic services resource with expanded global capabilities.

Beckman Coulter Genomics’ team has expertise and experience on a wide range of genomic technology platforms and is dedicated to delivering the highest quality results. Services currently available through Beckman Coulter Genomics include sequencing, sample preparation, genotyping, gene expression, biological efficiency, and safety testing, with support for all levels of regulatory compliance, including Clinical Laboratory Improvement Amendments (CLIA). In addition, Beckman Coulter Genomics offers all three commercially available next-generation sequencing platforms: Roche 454 Genome Sequencer FLX with Titanium, Applied Biosystems SOLiD, and Illumina Genome Analyzer.

IVD Companies Collaborate with Pharma on Companion Diagnostics

Tuesday, August 11th, 2009

Dako has signed an agreement with Genentech Inc. to collaborate on the regulatory submissions of Dako’s HercepTest and HER2 FISH pharmDx as companion diagnostics for Herceptin (trastuzumab) in patients with advanced HER2-positive stomach (gastric) cancer. The collaboration involves the use of Dako’s extensive experience in developing cancer diagnostic tests to identify cancer patients who may receive greater benefits from a certain therapy.

Under the terms of the agreement, Dako and Genentech will collaborate on regulatory submissions for HercepTest and HER2 FISH pharmDx in the U.S. market to identify patients with stomach cancer who may be eligible for treatment with Herceptin if Herceptin is approved for use against that disease. The collaboration is in line with Dako’s ongoing strategy to combine its strengths with biotechnology and pharmaceutical companies to develop the offering of Dako’s companion diagnostic assays.

Also, Nanosphere Inc. announced that it has entered into an agreement with Eli Lilly and Co. to collaborate in connection with employing pharmacogenetic assays in drug development initiatives. The two companies have signed the agreement and the financial terms were not disclosed.

Nanosphere is developing the pharmacogenetic assays for use with its new Verigene SP(r) system, a sample-to-result, benchtop molecular diagnostics instrument. The turnkey and random access system uses whole blood and requires no PCR. It allows for broad dissemination to recruitment sites which have no molecular laboratories, or to facilities already performing genetic testing.

Clinical Data Posts Positive Results

Monday, August 10th, 2009

Clinical Data Inc.  announced operational and financial results for the first fiscal quarter ended June 30, 2009. During the quarter, the company reported that gross revenue for Clinical Data’s PGxHealth Familion genetic testing business grew $1.7 million or 81% to $3.7 million compared to the same period a year ago.

The company sold the Cogenics division to Beckman Coulter for initial proceeds of $13.1 million, excluding $2.2 million in cash retained prior to the sale and $2.5 million held in escrow.

The company reported that Familion genetic testing revenues increased sequentially by 15% from the prior quarter and by 81% from the same period a year ago. Gross profit margins increased 27 percentage points to 55% for fiscal Q1 2010 compared to 28% for the same period a year ago. The company announced a newly enhanced Familion Long QT Syndrome (LQTS) Test that will double the number of genes analyzed. This follows the 3-gene expansion of the Familion Hypertrophic Cardiomyopathy (HCM) Test released earlier this year. The company achieved significant growth in positive reimbursement from private and public insurers, with coverage for 230 million lives up from 130 million from the same period a year ago

AdvaMed Reacts to Senate Hearings on Medical Device Safety Bill

Thursday, August 6th, 2009

Stephen J. Ubl, AdvaMed’s president and CEO, released the following statement regarding the hearings before the Senate Committee on Health, Education, Labor and Pensions on the Medical Device Safety Act of 2009 (S. 540):

“As Congress works to improve patient access to affordable, quality healthcare, we are concerned that the Medical Device Safety Act, an effort to repeal FDA’s preemptive federal authority, will result in increased healthcare costs and decreased patient access to life saving and life enhancing medical treatments.

“This bill will not in any way improve patient safety. It will create more frivolous lawsuits and increase healthcare costs, and it will make it harder for small medical device manufacturers to invest in promising new technologies. The bill also will weaken FDA’s regulatory authority.

“Congress gave FDA authority over the regulation of medical devices more than 30 years ago. Removing preemption over medical devices would effectively allow state courts and lay juries to make determinations about the safety of medical devices. We need a central, expert authority to make these decisions based on sound science and in the interest of public health.

“Congress should reject the inaptly named Medical Device Safety Act and reinforce the singularly important role FDA has in regulating the medical device industry. This is in the best interest of patients and our healthcare system.”

Companies Collaborate on IVDs for Crops

Tuesday, August 4th, 2009

TwistDx Ltd., a developer of point-of-use nucleic acid diagnostics, have made strong progress toward developing rapid, DNA-based field tests with Monsanto Company. Monsanto plans to use the tests to enhance the efficiency with which biotechnology crops are delivered across the globe.

To develop the tests, the companies are using TwistDx’s proprietary recombinase polymerase amplification (RPA) technology. RPA is a novel DNA amplification technology that enables the tests to produce results faster than other DNA detection tests available today, while maintaining a very high level of specificity and sensitivity.

Under the collaboration agreement, TwistDx received an undisclosed upfront payment. Additional payments could come in the form of research funding, payment upon reaching specific development milestones, and royalties from net sales resulting from commercialization of any test resulting from the collaboration.

Micronics Receives NIH Grant

Monday, August 3rd, 2009

Micronics Inc. (Redmond, WA) has been awarded a phase 2, two-year Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) totaling approximately $770,000 to advance its rapid molecular diagnostic infectious disease platform for detection of mother-to-child transmission (MTCT) of HIV.

The overall objective of the NIH grant is to determine whether the MTCT-HIV test that Micronics is developing for point-of-care applications can provide the same kind of information as the current nucleic acid tests in use today. Under a successful phase 1 effort, Micronics and collaborators at CDC demonstrated the feasibility of HIV detection from a droplet of whole blood applied to a disposable, microfluidics-enabled cartridge containing all of the required reagents and controls. Results showed that the sensitivity observed in the Micronics cartridge was acceptable for qualitative detection of HIV-1 DNA in infected individuals. During the phase 2, Micronics will expand development of its point-of-care MTCT-HIV assay, including performance of preclinical assessment studies to confirm limit of detection and comparison studies against current test methods.