The Dark Report

Despite COVID-19, Regular Lab Testing Expands

TIMES ARE GOOD FOR THE REGULAR RANGE of clinical laboratory and anatomic pathology testing services. Despite the COVID-19 pandemic, the daily number of routine test specimens is near pre-pandemic levels and certain sectors of lab testing—particularly genetic tests and some high-cost assays—are showing substantial growth this year, compared to 2019.  It may surprise many clinical …

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

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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What Comes Next? Predictions on COVID-19 Test Volumes in 2021-22

CEO SUMMARY: Incoming data show that the number of referrals for both COVID-19 tests and routine tests is in a decline that started in October and is continuing. This complicates the strategic planning for hospital/health system labs, independent labs, and pathology groups. They need to make accurate predictions about the demand for tests in coming …

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

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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March 22, 2021 Intelligence: Late-Breaking Lab News

This may be the nation’s first federal case of fraud and abuse involving a clinical laboratory company specializing in microbiome testing. In San Francisco last week, federal prosecutors filed multiple criminal charges against bankrupt uBiome, formerly based in San Francisco, Jessica Richman, uBiome’s former CEO, and Zachary Apte, its former chief scientific officer. The company …

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Might Politics Sway California Lab’s CLIA Compliance?

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

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

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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