Top Articles

FDA Replaces March 16 Serology COVID-19 Rules

Before issuing new guidance on May 4, the FDA okayed more than 200 tests, some were fraudulent

CEO SUMMARY: In the rush to allow companies and clinical laboratories to develop, validate, and bring to market serological tests for COVID-19, the federal Food and Drug Administration issued rules on March 16 that eased its requirements for these new assays. Because of the la...

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COVID-19 Update Expert Offers Comments on FDA and Revised Serology Test Rules

Tougher rules issued on May 4 show FDA’s concern about faulty or fraudulent COVID-19 serological tests

CLINICAL LABORATORY DIRECTORS are asking what caused the federal Food and Drug Administration (FDA) to issue a highly questionable policy in March to allow serological tests for SARS-CoV-2 and then change that policy seven weeks later. Under a policy the agency issued March...

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Legal Update New Lab Revenue Source: COVID-19 Worker Screening

CLINICAL LABORATORIES have a new revenue-generating opportunity, as some states relax stay-at-home rules: Many employers are likely to seek COVID-19 screening tests for employees returning to work to detect the presence of the new coronavirus. This new source of lab specimens and revenue gi...

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California Research Team Analyzes Performance of 12 Serology Tests

Consistent method used to evaluate different serology tests

CEO SUMMARY: Researchers with the COVID-19 Testing Project used a multidisciplinary effort to analyze and compare the performance of 12 serological tests. One finding is that, 16 to 20 days or more after a confirmed infection with a molecular test, many of the 12 serological te...

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To Stay Afloat, Dallas AP Group Cut Staff, Payroll

Early planning and federal funding also helped pathologists cut losses from COVID-19 pandemic

CEO SUMMARY: As early cases of COVID-19 spread in some states, pathologists at the 50-member ProPath group in Dallas prepared for a widespread outbreak by preserving cash and working with bankers and other advisors to apply for federal stimulus funding. Executives also fur...

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Helping Labs with Cash Flow, COVID-19 Response

ROUTINE SPECIMEN VOLUME REMAINS DOWN by 50% or more for clinical laboratories and anatomic pathology groups in the United States because of the pandemic. Through the end of last week, The Dark Report estimates that labs in the U.S. have lost almost $7 billion since the first week of March. That’s when patients stopped visiting their doctors and hospitals ce...

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