March 12, 2007 “Intelligence: Late Breaking Lab News”

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It’s the first opportunity to see how a New York-area laboratory is doing at grabbing UnitedHealth business. Bio-Reference Laboratories, Inc. (BRLI) of Elmwood Park, New Jersey, announced earnings for its first quarter (ending on January 31) in its 2007 fiscal year. Bio-Reference was pleased to report that its revenues increased by 25% for the quarter, from $42.9 million in 2006 to $53.7 million. It attributes this to a 15% increase in patient volume, split almost equally from new account gains in the New York metropolitan region and increased specimens from its esoteric testing.


In fact, esoteric testing continues to be a strong growth area for Bio-Reference. It says that esoteric testing increased from 36% of its revenues in 2006 to 43% for the current quarter. Bio-Reference also linked gains in esoteric testing to its higher revenue per requisition. For Q1-2007 it was $63.21, compared to $58.26 for the same quarter in 2006.


Many of you saw the Dark Daily e-briefing last week about Senator Ted Kennedy’s (D-MA) introduction of his bill to regulate “home brew” laboratory tests. (www.dark This is the second bill in the senate concerning genetic testing. Last August, Senator and Presidential contender Barack Obama (D-IL) introduced a bill entitled the “Genomics and Personalized Medicine Act of 2006” (S.3822). The interest of the two senators in introducing legislation about genetic testing demonstrates that politicians see political capital in molecular medicine. For the laboratory industry, there’s more bad news than good news in this development.

ADD TO: Genetic Tests

The bad news is the potential for politicians to focus on the scam artists and unethical businesses which lie around the fringe of the healthcare system and offer services of little or no clinical value to desperate people. In regulating genetic testing to control their actions in the market, politicians often unintentionally add significant burdens to legitimate and conscientious healthcare providers. Thus, although a bill like Obama’s wants to encourage advancements in genetic tests, bills like Kennedy’s can offset those gains in extremely harmful ways. This is why laboratory managers and pathologists should keep a watchful eye on the parade of politicians wanting to use regulation of genetic testing as a way to accumulate political capital.


In recent years, Digene Corporation has held a dominant market share in HPV testing. However, this lucrative market is attracting the attention of competitors. Roche Holding AG is working on HPV tests that will identify up to 13 different HPV strains. Last week, Roche said a filing with the FDA on these tests was imminent. Gen-Probe and Third Wave Technologies are also known to be developing their own HPV assays.


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