Federal Lawsuit Favors Lab Accused of AKS Violations

By Robert Michel | From the Volume XXXII, No. 2 – January 27, 2025 Issue

CEO SUMMARY: This whistleblower lawsuit initially charged a clinical lab with, among other things, violating the Anti-Kickback Statute and EKRA. After the judge ruled to exclude the AKS and EKRA claims, the whistleblower refiled the case and included claims the lab paid commissions for th…

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Despite COVID-19 Losses, IVD Executives Remain Upbeat

By Donna Marie Pocius | From the Volume XXX, No. 8 – May 30, 2023 Issue

Continuing declines in COVID-19 test revenues was a common theme during the first quarte…

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News and Insights from AACC Meeting in Chicago

By Robert Michel | From the Volume XXIX, No. 11 – August 8, 2022 Issue

CEO SUMMARY: There was plenty of positive energy last month when the 72nd Annual Scientific Meeting and Exhibition of the American Association of Clinical Chemistry (AACC) took place in Chicago. Attendees seemed pleased to be gathering and networking in person. However, there was re…

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Amazon to Close Employee COVID-19 Testing Lab in Ky.

By Robert Michel | From the Volume XXIX, No. 8 – June 6, 2022 Issue

IN A MOVE THAT MAY SURPRISE SOME OBSERVERS, Amazon announced it will close its COVID-19 employee testing laboratory in Hebron, Ky., which is just across the Ohio River from Cincinnati.  This is the second large COVID-19 clinical laboratory to publ…

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Anticipating Change in COVID-19 Test Volume

By Robert Michel | From the Volume XXIX, No. 6 – April 25, 2022 Issue

CEO SUMMARY: New and more easily transmitted variants of SARS-CoV-2 are causing surges…

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Leveraging Testing Technology To Identify MRSA, C. Difficile

By Joseph Burns | From the Volume XX No. 3 – March 4, 2013 Issue

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…

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November 03, 2014 Intelligence: Late-Breaking Lab News

By Robert Michel | From the Volume XXI No. 15 – November 3, 2014 Issue

In response to the Ebola outbreak, the Food and Drug Administration issued an emergency authorization for the use of two rapid tests to detect Ebola. The tests are manufactured by BioFire Defense LLC, a division of BioMerieux. The BioFire Defense Fil…

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TriCore Lab Adds Value with Consults, Better TAT

By Joseph Burns | From the Volume XX No. 8 – June 17, 2013 Issue

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…

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“Liked the Product–Bought the Company,” BD Acquires HandyLab and Jaguar System

By Robert Michel | From the Volume XVI No. 16 – November 23, 2009 Issue

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…

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GSK and Abbott Team up For Companion Diagnostic

By Robert Michel | From the Volume XVI No. 14 – October 12, 2009 Issue

CEO SUMMARY: Although GlaxoSmithKline PLC is several years away from having a deliverable product from its Antigen Specific Cancer Immunoassay (ASCI) Program, it has a development deal with Abbott Laboratories to produce a companion diagnostic test for ASCI-based products. The in…

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