April 20, 2015 Intelligence: Late Breaking Lab News

It’s a lawsuit that Quest Diagnostics Incorporated can’t seem to make go away. Last week in California, a federal judge ruled Hunter Laboratories and Surgical Pathology Associates (SPA) can continue to pursue their antitrust lawsuit against Quest Diagnostics. Plaintiffs allege that Quest conspired to monopolize lab testing in California. Hunter Laboratories claimed it was harmed because Quest Diagnostics sold lab tests below cost. SPA claimed it was harmed because Quest had below-cost capitated con- tracts with certain payers.

MORE ON: Lawsuit

In November 2012, Hunter, SPA, and three other California labs filed the original antitrust complaint against Aetna, Quest, Blue Shield of California, and the Blue Cross and Blue Shield Association. After more than two years of legal maneuver- ing, only the two claims of Hunter and SPA remain. One interesting legal aspect to this case is that it has claims under California’s statutes that prohibit a company from selling below its cost.

University of Michigan System Plans $160M LAB

In this age of shrinking lab budgets, the University of Michigan Health System’s plan to spend $160 million on a new lab shows how much UMHS values lab medicine’s ability to improve patient outcomes. Currently, the 450 faculty and staff work in 10 different lab locations across the campus. Following con- struction of the new 139,000- square-foot lab in four vacant buildings in the school’s North Campus Research Complex, they will all work in the new lab facility. The lab is in the design phase and no date for the start of construction has been announced.

Labs, DX Makers Draft Compromise Plan on LDTs

As the FDA considers regulating lab-developed tests (LDTs) as medical devices, the lab industry is presenting alternative ways to review and approve LDTs. The latest alter- native comes from a working group of labs and diagnostics manufacturers who offered a compromise. Under this plan, labs would get more regulation of LDTs but they would keep the FDA away from regulating LDTs as medical devices, according to a report in the FDA Law Blog. The proposal could form the basis of legislation to be released soon, according to the law blog. Genome Web reported that participants in the working group include ARUP Laboratories, Becton Dickinson, Laboratory Corporation of America, Mayo Clinic, and Roche.

Dark Daily Update

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

…how Cornell researchers identified gut microbes that apparently help people to stay thin. This insight could lead to another category of clinical lab tests to analyze patients’ microbiomes as part of clinical weight control efforts.

You can get the free DARK Daily e-briefings by signing up at www.darkdaily.com.

That’s all the insider intelligence for this report. Look for the next briefing on Monday, May 11, 2015.

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