Issue: Volume XXVII No. 7 - May 11, 2020

June 1, 2020 Intelligence: Late-Breaking Lab News

Daily, national news¬†headlines call attention¬†to the lack of adequate¬†testing for COVID-19.¬†News reporters question why¬†clinical labs are unable to meet¬†the demand for SARS-CoV-2¬†tests. One major reason is the¬†lack of adequate supplies labs¬†need to collect specimens,¬†transport them, and perform¬†COVID-19 tests in large¬†numbers. This is one finding¬†of a study conducted by the¬†Association for Molecular¬†Pathology (AMP). In a press¬†release …

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California Research Team Analyzes Performance of 12 Serological Tests

This is an excerpt of a 2.241-word article in the May 11, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Researchers with the COVID-19 Testing Project used¬†a multidisciplinary effort to analyze and compare the performance of 12¬†serological tests, and shared their results¬†with …

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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‚Äôs when patients stopped visiting their doctors and …

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FDA Replaces March 16 Serology COVID-19 Rules

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 lack of oversight under the March 16¬†rules, the market was flooded with tests, including some …

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Expert Offers Comments on FDA and Revised Serology Test Rules

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 16, the FDA granted what it called¬†‚Äúregulatory flexibility for developers offering¬†such tests without FDA review and¬†without an emergency use …

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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 gives clinical labs an opportunity¬†to replace some revenue lost since early¬†March. That is when routine daily specimen¬†volume began to …

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California Research Team Analyzes Performance of 12 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 tests analyzed¬†were 80% positive. Using donated blood samples, the researchers¬†assessed the volume and …

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To Stay Afloat, Dallas AP Group Cut Staff, Payroll

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 furloughed pathologists and¬†other staff temporarily before using federal funds to bring them¬†back. Despite a 65% drop in …

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MAY 11, 2020 Intelligence: Late-Breaking Lab News

Clinical laboratories in¬†other countries have¬†similar challenges in¬†responding to the COVID-19 pandemic. In the United¬†Kingdom, the Independent¬†reported last week that ‚ÄúWidespread¬†testing for coronavirus¬†has been suspended among¬†staff and patients at hospitals¬†and GP practices serving 3.5¬†million people because of a¬†shortage of vital chemicals.‚Ä̬†According to Independent¬†reporter Shaun Lintern, medical¬†laboratories serving South¬†London are unable to access¬†adequate supplies of reagents¬†and other …

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