Issue: Volume XXV No. 5 - March 26, 2018

Powerful Forces Are Reshaping Lab, Pathology

THERE IS NO BETTER WAY TO UNDERSTAND HOW THINGS ARE CHANGING within the house of laboratory medicine than to survey current news. Understanding why and how breaking news stories are indicators of deeply-rooted and forceful trends is essential for lab administrators and pathologists who want to keep their labs positioned to offer sophisticated and financially-sustainable …

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SEC Charges Theranos with ‘Massive Fraud’

CEO SUMMARY: In an action against Theranos and two of its executives, the SEC said in a federal court filing this month that the company, CEO Elizabeth Holmes, and former COO Ramesh “Sunny” Balwani deceived investors into believing that the company’s portable blood analyzer could conduct comprehensive blood tests from drops of blood collected via …

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Facing Lawsuit Filed by Humana, Ameritox Closes Lab, Sells Assets

IN MAY, THE LONG-STRUGGLING Ameritox, LLC, is scheduled to close its laboratory in Greensboro, N.C., according to reporting in the Triad Business Journal. Early this month, the drug-monitoring and urine-analysis company filed a notice with the North Carolina Department of Commerce that it would close the lab and lay off 113 workers. Also, the company …

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FDA’s Gottlieb Favors Flexibility with LDTs, NGS

CEO SUMMARY: FDA Commissioner Scott Gottlieb said the FDA wants to reduce the regulatory burden on developers of next-generation sequencing (NGS) and laboratory-developed tests (LTDs). He also wants to give the FDA more flexibility in how it conducts clinical analysis and validation. To do so, the agency would work with third parties, such as the …

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Why Pharma, Private Equity Want to Reshape Lab Industry

CEO SUMMARY: A disruptive force that involves precision medicine, pharmaceutical companies, and venture capital investors is poised to reshape the clinical laboratory industry. Genetic knowledge makes it possible to match cancer drugs to specific mutations. Pharma companies and professional investors recognize that control of diagnostic technologies and companion diagnostic tests enable them to gain better access …

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D.C. Circuit Court Reverses Medical Necessity Ruling

MANY LAB EXECUTIVES were concerned last year after a judge in the District of Columbia Circuit Court ruled that clinical laboratories need to determine that all lab test services physicians order are medically necessary. The court also ruled that ordering physicians do not need to determine medical necessity, noted the law firm McDonald Hopkins in …

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March 26, 2018 Intelligence: Late Breaking Lab News

On March 6, one of the lab industry’s long-serving executives and consultants, Jack Mattice, PhD, of Vancouver, Wash., died from flu complications. He was 77 years old. Mattice earned a PhD in medical microbiology from University of Oregon. Within a few years, he was handling market development for United Medical Laboratories (UML), of Portland, Ore. UML reached …

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