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Search Results for: COVID-19

April 12, 2021 Intelligence: Late-Breaking Lab News

Late Breaking Lab News / By

One clinical laboratory company now says it provides COVID-19 testing services to all five of the major men’s professional sports leagues in the United States. On April 1, BioReference Laboratories, Inc. (BRLI), a division of Opko Health, announced a new agreement with Major League Baseball. In its press release, BRLI said it will provide COVID-19 …

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Volume XXVIII No. 5 – April 12, 2021

The Dark Report notes that Amazon is now selling at-home COVID-19 test kits as yet another move by the retail giant into the healthcare space. Also in this issue is a report on how IVD firms have benefitted from the pandemic in many ways, not the least of which is financial.

Revised Stark Law, Anti-Kickback Statute Rules Are Good News for Labs

TDR Insider / By

This is an excerpt of a 1,385-word article in the March 22, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: The Dark Report explains how changes to the Stark Law and Anti-Kickback Statute will benefit labs, according to attorneys representing clinical labs and pathology …

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Revised Stark and AKS Rules Are Good News for Labs

Laboratory Compliance / By

CEO SUMMARY: It must be rewarding for federal rulemakers at the Centers for Medicare and Medicaid Services and the Office of the Inspector General to hear that attorneys representing clinical labs and pathology groups consider the new final rules for the Stark Law and the Anti-Kickback Statute to be helpful for clarifying how labs and …

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Roche to Acquire GenMark, Ovation.io Raises $21.5M

In Vitro Diagnostics / By

Roche to Pay $1.8 Billion for GenMark  THERE’S MORE CONSOLIDATION in the in vitro diagnostics (IVD) industry. It was announced on Mar. 15 that Roche Diagnostics would acquire GenMark Diagnostics of Carlsbad, Calif., for a purchase price of $1.8 billion.  With access to GenMark’s technology, which enables rapid testing of many pathogens from one sample, …

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Truvian Sciences Raises $105M for Near-Patient Lab Test System

In Vitro Diagnostics, IVD/Lab Informatics / By

DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accurate results in just minutes.  That would describe the …

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Might Politics Sway California Lab’s CLIA Compliance?

Commentary and Opinion by R. Lewis Dark / By

IS IT A CONFLICT FOR A STATE GOVERNMENT TO BUILD AND OPERATE A CLIA high-complexity clinical laboratory and have the same department that manages this lab facility also conduct the CLIA-mandated inspections and oversight of the lab’s compliance, as required by the federal Clinical Laboratory Improvement Amendments (CLIA)?  That is the situation in California today. …

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New Year Brings Three New Clinical Lab Trends

Clinical Laboratory Trends / By

CEO SUMMARY: Since the year began, three trends have affected clinical laboratories and anatomic pathology groups. First is a continuing surge in COVID-19 test volume. Second is inconsistent payment from government and commercial insurers for SARS-CoV-2 test claims. Third is growing consumer acceptance of digital devices to monitor their health, a trend that leads them …

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Whistleblowers Disclose Issues in California’s COVID Lab

Laboratory Compliance / By

SUMMARY: Whistleblowers at the State of California’s brand-new COVID-19 Valencia Branch Laboratory are telling reporters about staff sleeping on the job, unlicensed staff handling specimens, and other significant issues. Given the reports of several news outlets, one relevant question for the clinical laboratory profession is whether state lab inspectors, federal CLIA officials, and the College …

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SARS-CoV-2 Variant Sequencing Offers Clinical Opportunities

Clinical Laboratory Trends / By

CEO SUMMARY: In Wisconsin, an oncology research lab started sequencing variants of the SARS-CoV-2 virus and found multiple uses for such test results to help hospitals, health systems, schools, and municipalities identify infection sources and track the virus’ spread. In one case, the lab identified a sub-strain of the virus that appeared to be linked …

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