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Invitae’s Troubled Journey: Rise, Fall, and Bankruptcy
ON MAY 7, THE REMNANTS OF GENETIC TESTING GIANT INVITAE (NYSE: NVTA) were scooped up by …
Clarapath Automates Slide Prep, Microtomy Workflow
>>CEO SUMMARY: Histology is one area of laboratory medicine that utilizes a mostly manual work flow. However, pathology labs will soon have a novel solution designed to automate many of the steps in microtomy that produce glass slides. Reduced variability in the finished glass s…
ACLA President Van Meter Discusses LDT Lawsuit
CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi…
Lab’s Innovation Center Encourages Staff Ideas
CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the “Innovation Center of Excellence.” One innovation involves helping health plans and ph…
Wisc. Diagnostic Lab’s Alternative Staff Solutions
CEO SUMMARY: Even as clinical laboratories and pathology groups around the nation cope with a sustained shortage of qualified staff, the team at Wisconsin Medical Laboratories has successfully kept staffing at 96% of authorized levels. One effective strategy they use is to go into the com…
Pathologist Paul A. Brown, MD, MetPath Founder, Dies at 85
EARLIER THIS YEAR, THE PATHOLOGY PROFESSION LOST one of what some call “the two Lions of Pathology.” On January 24, 2024, Paul A. Brown, MD, aged 85, died at his home in Palm Beach, Florida. In 1967, Brown was the founder of Metropolitan Pathology Laboratory, Inc., based in Ne…
Attorney Discusses Federal Cases Involving EKRA Violations by Labs
IT’S BEEN MORE THAN FIVE YEARS since Congress passed the Eliminating Kickbacks in Recovery Act of 2018 (EKRA). Lab managers and their attorneys quickly recognized that, whereas the Anti-Kickback Statute (AKS) has a safe harbor that permits percentage-based sales commissions to W2 employees, EKRA does…
Is There Evidence That Some Doctors Wish to Use Local Labs?
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Feds Bar Elizabeth Holmes from Government Health Programs
ONCE AGAIN, ELIZABETH HOLMES, THE DISGRACED FORMER CEO OF THERANOS, is in the news. This time it is because the federal Department of Health and Human Services (HHS) Office of the Inspector General (OIG) announced in January that Elizabeth Holmes is …
23andMe Says Big Data Breach Due to Customers’ ‘Negligence’
LAST OCTOBER, ONE HIGH PROFILE COMPANY THAT DOES GENETICS TESTING acknowledged it had experienced a data breach involving thousands of its customers. Then came an unexpected turn in this data breach event. In subsequent public statements during December, 23andMe stated that the or…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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