IVD Technology Magazine
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Originally published September, 1998

IVD Technology News

More changes and challenges for Oncor

So, Oncor, Inc. (Gaithersburg, MD), has finally settled its lengthy patent dispute with Vysis, Inc. (Downers Grove, IL). The company has paid the first round of royalties for its use of the Vysis fluorescence in situ hybridization (FISH) technology, and has relinquished its nononcology business. Time to get the ship righted . . . right?

Well, maybe not just yet.

According to Dawn McHugh, Oncor diagnostics products marketing manager, the company is ready to go "100% forward in the oncology field"—the key product area left after its settlement with Vysis. One of Oncor's newest and highest profile products is the Inform her-2/neu breast cancer test, which received FDA approval last December. The test is a molecular assay that uses the FISH technology, now under a license from Vysis.

But in June, Oncor discovered that its dealings with its old nemesis weren't quite done, as Vysis filed a premarket approval (PMA) application for its own her-2 gene test. Marketing of Vysis' Pathvysion her-2 DNA probe kit will place it in direct competition with Oncor.

According to John Bishop, Vysis president and CEO, "the difference with our test is that it includes a chromosome 17 control." The her-2 gene resides on chromosome 17 and false positive results can arise unless a control is used. "Having two separate probes for chromosome 17 and her-2 means that our test can distinguish between aneuploidy and amplification," Bishop explains. Aneuploidy is an excessive number of chromosomes that is not necessarily an indicator of breast cancer, while specific amplification of the her-2 gene is indicative of a type of breast cancer that is characterized by rapid tumor growth and resistance to therapy.

To complicate matters, Oncor will have to face the challenge of competition without its research products division. Also in June, Intergen Co. (Purchase, NY) announced that it had acquired the division, which will become part of newly formed Intergen Discovery Products LLC. Maria Reda, advertising and communication coordinator for Intergen, says that the company plans to "combine Oncor's product line with our existing technology to provide biodiagnostic reagents and raw materials." Intergen's expanded product line will encompass molecular biology, oncology, and high throughput screening.

An Intergen press release quoted Oncor president Cecil Kost as saying, "Intergen represents a great strategic buyer of this business and an important partner to Oncor in expanding applications . . . outside the patient management arena."—Gary Woo