August 23, 2010 “Intelligence: Late Breaking Lab News”

With the goal of developing biomarkers useful in diagnosing a variety of cancers, Pathwork Diagnostics, Inc., and Novartis AG announced a research partnership on July 30. It is an early example of a collaboration between a diagnostics company and a pharmaceutical company for the specific purpose of producing assays for use as “companion diagnostics”— diagnostic tests that can identify whether a patient will benefit from a specific therapeutic drug. Last October, Novartis entered a similar commercial partnership with Orion Genomics LLC to jointly identify and develop epigenetic biomarkers.

MORE ON: Pathwork

Redwood City, California-based Pathwork Diagnostics offers a cancer “Tissue of Origin” test that utilizes microarray technology from Affymetrix Inc. to measure the expression levels of more than 2,000 genes. Last June, Pathworks announced that the FDA “had cleared the Pathwork Tissue of Origin Test for formalin-fixed, paraffin-embedded (FFPE) tissues. The FDA clearance allows the Tissue of Origin Test to be broadly utilized on common clinical FFPE tumor specimens from both community and research hospitals and paves the way for additional FFPE-based cancer tests on the Pathwork platform.”


In closing its fiscal 2010 year on June 30, Myriad Genetics, Inc., reported that full-year revenues had increased 11%, to $362.6 million, compared to $326.5 million in 2009. Most pathologists and clinical laboratory managers do not realize that annual revenue at Myriad now exceeds a third of a billion dollars. Its BRCAnalysis test was responsible for $82 million of the company’s fourth quarter revenue of $93.9 million. Myriad’s genetic risk tests for colorectal cancer and uterine cancer generated an additional $7.3 million in revenue for the quarter.


It may be the final push in the race to be first to achieve the $1,000 whole human genome sequence. This summer, both Complete Genomics, Inc., and Pacific Biosciences filed S-1 registration documents as a first step to initial public offerings (IPO). Complete Genomics hopes to raise $86 million. Pacific Biosciences seeks $200 million.

Dark Daily Update

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about…

…how more community hospitals are using the newest assays and automated systems to beef up in-house molecular diagnostics programs, particularly for infectious disease and cancer testing.

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