TAG:
pcr testing
Ruling Limits Lab Onus on Medical Necessity
CEO SUMMARY: A federal appeals court ruling has established a legal “safe harbor” for clinical laboratories, shifting the burden of proof in False Claims Act cases. By allowing labs to generally rely on physician orders as evidence of medical necessity, the decision pr…
Clinical Labs Must Prep for Heightened Audits
CEO SUMMARY: A new report from the Office of Inspector General sheds interesting light on just how much genetic testing has increased among Medicare Part B beneficiaries. With billions of dollars in reimbursement at stake for clinical laboratories, expect federal officials…
One Lab’s Solution to Its Histotechnologist Shortage
Histology workforce shortages remain one of the major challenges within the clinical laboratory industry, and, unfortunately, as the demand for histotechnologists increases, the number of qualified personnel has been decreasing. A report releas…
Leveraging Testing Technology To Identify MRSA, C. Difficile
CEO SUMMARY: Probably the most challenging infections for hospitals to control and reduce are methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile (C. diff). The laboratory at one New York hospital introduced algorithms to screen for the presence of each i…
TriCore Lab Adds Value with Consults, Better TAT
CEO SUMMARY: Motivated by the goal of delivering more value to clinicians and client hospitals, the lab team at TriCore Reference Laboratories in Albuquerque, New Mexico, is proactively introducing new services. One such initiative is to travel to hospitals to participate in rounds and co…
“Liked the Product–Bought the Company,” BD Acquires HandyLab and Jaguar System
IT WAS 1979 WHEN VICTOR KIAM jump-started sales of Remington electric razors with his classic, witty ad campaign, “I liked the product so much, I bought the company!” Now the same thing is happening with a benchtop-sized automated system for molecular PCR testing. In this case, it is Bec…
Influenza A Test Is a Help When Screening for H1N1
CEO SUMMARY: Viracor Laboratories is preparing to handle expanded volumes of influenza testing prior to the start of the next flu season. It will use added instrumentation and expanded working hours to expand capacity. Another strategy is to use influenza A testing as a way to re…
Competition in Rapid Tests Means Value to Labs
CEO SUMMARY: One of the hottest market segments in in vitro diagnostics (IVD) is rapid testing. However, because labs now often have multiple choices when selecting a rapid test, IVD manufacturers recognize the need to differentiate their products by adding additional features an…
Bill Bonello Sees Opportunities In Diagnostic Services Companies
CEO SUMMARY: With the clinical laboratory industry now enjoying growing interest by professional investors, THE DARK REPORT traveled to New York City to meet with financial analyst William B. Bonello, of U S Bancorp Piper Jaffray. Bonello co-authored a just-released overview of what he ca…
Court Rules Against Roche In PCR/Taq Patent Dispute
DECEMBER 7, 1999 WAS NOT an auspicious day for Hoffmann-LaRoche. One of its patents related to the PCR testing process was ruled invalid by a Federal District Court. The ruling involved Roche’s ’818 Taq patent, an enzyme used in the PCR process. The Court found that the patent h…
CURRENT ISSUE
Volume XXXIII, No. 5 – April 13, 2026
Another integrated delivery network mega-deal has been proposed, with California’s Sutter Health planning a merger with Minnesota’s Allina Health. Also, refunds for President Trump’s illegal tariffs may be forthcoming for IVD importers, but it will be a struggle.
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