September 25, 2006 “Intelligence: Late Breaking Lab News”

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On September 8, Becton, Dickinson & Company (BD) announced that it would acquire TriPath Imaging, Inc. for a purchase price of approximately $350 million. TriPath’s share price has not moved significantly over the past five years, so many shareholders were pushing for change. BD and TriPath have been close collaborators in several areas of molecular technology development.

CYTYC BIDS FOR VISION

There was an interesting catfight between Ventana Medical Systems, Inc. and Cytyc Corporation. In August, Ventana and Vision Systems Ltd. of Sidney, Australia, entered into a friendly agreement. Ventana would pay about US$346 million to buy the manufacturer of instruments and reagents used in diagnosing cancer. On September 18, Cytyc announced a tender offer to acquire Vision Systems, at a price of about US$374 million. Ventana ceded the sale of Vision Systems to Cytyc, but has filed a patent infringement suit against Vision Systems.

FDA ISSUES GUIDANCE ON MOLECULAR TEST APPROVALS

Earlier this month, the Food and Drug Administration (FDA) issued a document that is the first step to assert a role for the agency in regulating “in vitro diagnostic multivariate index assays”(IVDMIAs). On September 7, the FDA posted “Draft Guidance for Industry, Clinical Laboratories, and FDA Staff—In Vitro Diagnostic Multivariate Index Assays” on its Website. (https://www.fda.govcdrh/ oivd/guidance/1610.html). The FDA has been communicating with Genomic Health, Inc. of Redwood City, California. Genomic Health’s Oncotype DX is a multivariate, algorithm based-assay. It began marketing the assay in 2005, without filing for pre-market review.

ADD TO: FDA Actions

Experts consider the FDA’s release of the draft guidance to be a sign that the agency wants to issue more definitive regulations that will address assays that incorporate MIAs. It is already developing guidance that affects ASRs (analyte specific reagents). In the draft guidance, the FDA says an IVDMIA tests is a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act. Posting of the draft guidance starts a 90-day comment period. Lab industry groups are studying the new draft guidance and preparing a response.

For the first time, the Florida Health Care Coalition, (FHCC) has released its annual survey of HMO quality to the public. This year’s survey, which included six HMOs, showed that none of them were consistently matching national benchmarks for quality. FHCC represents many of Florida’s large employers on healthcare issues. Eight measurements of plan quality were surveyed. The highest scoring national plan had a score of 95%. The top score for any of the Florida HMOs was Cigna, at 79%. The other scores were: Aetna–76%, Blue Cross and Blue Shield of Florida (BCBSF)–69%,United Healthcare–61%, Humana–59% and Vista–22%.

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