September 2008 Clinical Laboratory News: Industry Profiles

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September 2008: Volume 34, Number 9

  Affymetrix Boosts Portfolio with Asuragen IVT Reagent Kits

Affymetrix announced an agreement with Asuragen for in vitro transcription (IVT) reagent kits for clinical molecular diagnostics applications. Asuragen will develop and manufacture kits configured for use with Affymetrix’ GeneChip System 3000Dx, the only available diagnostic microarray platform to win FDA clearance. According to Asuragen’s chief scientific officer, Matt Winkler, the new reagent kits will facilitate greater adoption of Affymetrix microarray technology by improving workflow for clinical labs. Financial terms of the deal were not disclosed.

DNA Repair Company Get Exclusive Rights to Breast Cancer PGx Test

The Boston-based DNA Repair Company announced a licensing agreement with Helsinki University Central Hospital for the use of a newly discovered test that strongly predicts how women with breast cancer will respond to standard anthracycline-containing chemotherapy regimens. Researchers at the hospital discovered that the NQO1*2 enzyme, a variant that disables the production of the NQO1 protein, is a factor in breast cancer treatment response. Patients with NQO1*2 had worse survival outcomes when treated with anthracycline-based chemotherapy than with alternatives. Researchers found that women with a double copy of NQO1*2 in their genome had only a 17% survival rate, while those who had only a single copy or did not have a variant had a survival rate of 75% (Nature Genetics 2008;40:844–53). “The findings of the researchers on the effect of NQO1*2 on breast cancer survival were highly significant and hold important promise for predicting clinical outcomes for cancer patients,” said Daniel Paterson, CEO of the DNA Repair Company. “We are excited at the opportunity to employ this novel biomarker in our efforts to give physicians data-driven tools to identify the most beneficial treatment regimen for a particular patient.” Financial terms were not disclosed.

Agencourt and Third Wave Sign Agreement on New HPV Tests

Agencourt Bioscience announced a deal with Third Wave Technologies whereby the Agencourt Genfind DNA isolation system will be integrated into Third Wave’s new HPV tests, which are still under FDA premarket review. Agencourt is a subsidiary of Beckman Coulter, while Third Wave is owned by Hologic. The companies also agreed to collaborate on future products. “With the growing use of HPV testing to screen for cervical cancer, the marketplace has been demanding improvements in diagnostic tests,” said Kevin Conroy, CEO of Third Wave Technologies. “Agencourt’s nucleic acid preparation technology delivers the reliable recovery of purified DNA required for both our Cervista HPV HR and Cervista HPV 16/18 tests. Agencourt Genfind is also easily automated, allowing Third Wave to attend to the needs of our medium- to high-volume customers, a key part of the overall HPV strategy for our company.” Agencourt’s Genfind system uses proprietary paramagnetic bead-based nucleic acid purification that requires no organic solvents, vacuum filtration, or centrifugation steps. According to Third Wave, the global market for HPV testing will reach $250 million in 2008. Financial terms of the deal were not disclosed.

ARUP and Weber State University Team Up for Lab Tech Education

 ARUP Laboratories and Weber State University (WSU) announced a collaboration aimed at tackling shortages of qualified laboratory workers. Under the agreement, ARUP and WSU will offer ARUP clients access to Web-based courses in medical technology toward CLS bachelors’ degrees and CLT associates’ degrees. “According to the U.S. Bureau of Labor Statistics for the period of 2002 through 2010, 12,400 graduates will be needed annually to staff the nation’s clinical laboratories. However, on a national basis, fewer than half of the necessary laboratory personnel are graduating,” said ARUP president and COO Ronald Weiss, MD. “We are seeing these shortages become more critical within community health systems that are growing their outreach programs. This collaboration enables our client laboratories with an opportunity to educate laboratory personnel, without taking them away from their work sites.” The program will allow students to learn and earn credit while working in their own facility with the support of their employer instead of attending offsite classes, and graduates will be able to sit for the registry exams after finishing their AAS/CLT or BS/CLS degree. More information about the program is online.

TheraGenetics Inks Deal for Antidepressant Response Testing

TheraGenetics announced a licensing agreement with the Centre for Addiction and Mental Health (Toronto, Ont.) for methods and kits used to identify patients at greater risk for antidepressant side effects. “Since our inception in April 2006, we have made tremendous progress in our efforts to link genes to specific CNS disorders and use this information to predict patient response to treatment as well as drug side effects,” said Richard Kivel, CEO of TheraGenetics. “The intellectual property we have licensed from the Centre for Addiction and Mental Health further augments our capabilities to innovate pharmacogenetic diagnostics tests in a broad range of disorders, such as schizophrenia, depression, bipolar disorder, Alzheimer’s disease, and ADHD.” Financial details were not disclosed.

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