Issue: Volume XXIV No. 6 - April 24, 2017

Congress Seems Ready to Tackle LDT Regulation

RECENT DEVELOPMENTS SIGNAL THAT THE FIGHT over FDA regulation of laboratory-developed tests (LDTs) is about to intensify. Last month, two Congressional representatives announced a new bill about LDTs that they said was a “discussion draft.” The bill is titled the “Diagnostic Accuracy and Innovation Act (DAIA).” It was a big deal in 2014 when the …

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FDA Clears Digital Path for Primary Diagnosis

CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a milestone on April 12 when the FDA cleared the Philips digital pathology system for sale in the United States. Now pathologists can use the system to perform primary diagnoses and get paid for those professional services. It is expected that this regulatory …

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Digital Pathology Makes Group More Competitive

CEO SUMMARY: One 15-member pathology group said adopting digital pathology will give it more competitive advantage. Advanced Pathology Associates (APA) in suburban Maryland, was one of four sites that participated in the clinical study of the Philips IntelliSite Pathology Solution application for FDA clearance to use the system for primary diagnosis. The experience was of …

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Aurora Diagnostics Acquires Pathology Groups, Posts Loss

ONE OF THE MORE CURIOUS SITUATIONS IN THE LAB INDUSTRY TODAY is the story of Aurora Diagnostics of Palm Beach Gardens, Fla. Even as it loses money, it continues to acquire pathology group practices. Aurora recently issued its earnings report. For 2016, it disclosed a net loss of $29 million, with revenue of $284 million. …

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Diagnostic Error Rate Of 21% Revealed By Mayo Clinic Study

CEO SUMMARY: Researchers at the Mayo Clinic showed that only 12% of patients referred to Mayo physicians for a second opinion got a confirmation that their original diagnosis was complete and correct. In 21% of the cases, the diagnosis was completely changed. Among patients who got additional work ups for a second opinion, some 80% …

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Federal Regulation of LDTs Subject of Proposed Bill

THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy and Innovation Act (DAIA) was made …

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April 24, 2017 Intelligence: Late Breaking Lab News

Theranos, Inc., is again in the news. On April 17, the company disclosed a global settlement with the federal Centers for Medicare & Medicaid Services (CMS) to resolve “all outstanding legal and regulatory proceedings between CMS and Theranos.” The company said, pursuant to terms of the settlement, CMS withdrew revocation of the company’s CLIA operating …

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Philips digital pathology system scores huge success as FDA clears digital path for primary diagnosis

This is an excerpt from a 1,400-word article in the April 24, 2017, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group. CEO SUMMARY: Proponents of digital pathology systems and whole slide imaging achieved a …

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