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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 “regulatory flexibility for developers offering such tests without FDA review and without an emergency use […]

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California Research Team Analyzes Performance of 12 Serology Tests

Clinical Laboratory / Joseph Burns

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

Laboratory Management / Joseph Burns

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

Late Breaking Lab News / Robert Michel

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 “Widespread 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.” 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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Jude

Add Dark Daily news RSS to your website or RSS reader with this URL https://www.darkdaily.com/feed/Free ebrief membership at DarkDaily.com • Read all Dark Daily coverage about COVID-19 • Read all Dark Report articles about COVID-19 JOIN Dark Daily today and get free laboratory news ebriefs in your inbox.

Volume XXVII No. 6 – April 20, 2020

Mary Van Doren

COVID-19 NEWS IS HITTING the laboratory industry hard. With specimens — and therefore revenues — in a deep dive, lab finances are crashing, and COVID-19 testing isn’t entirely making up for the losses. But THE DARK REPORT shows labs how and where to apply for financial aid under federal relief packages. Meanwhile, a pre-eminent pathologist takes readers deep inside the Italian pandemic in an exclusive interview.

Volume XXVII No. 6 – April 20, 2020 Read More »

Companies Saw Big Drop in Lab Revenue from Mid-March

TDR Insider / Joseph Burns

This is an excerpt of a 2,083-word article in the April 20, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine care and hospitals ceased doing elective services. With fewer test referrals, clinical

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Clinical Labs Step Up, But Serious Problems Are Ahead

Commentary and Opinion by R. Lewis Dark / R. Lewis Dark

ACROSS THE UNITED STATES, CLINICAL LABORATORIES ARE LIVING a good news/bad news story. The good news is that the essential role every lab plays in enabling fast, accurate diagnoses is now at the top of the news cycle. Daily, citizens of this country hear from the President and health officials that it’s a clinical laboratory test for SARS-CoV-2 which

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Lab, Path Finances Crash; Next Test Wave: Serology

Clinical Laboratory Trends / Robert Michel

CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will get worse before it gets better. As of today, labs are watching their daily cash flow fall below operating costs,

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From Mid-March, Labs Saw Big Drop in Revenue

Clinical Laboratory Trends / Joseph Burns

CEO SUMMARY: In response to the coronavirus outbreak, patients stopped seeing their doctors for routine care and hospitals ceased doing elective services. With fewer test referrals, clinical labs and pathology groups were hit with a substantial decline in revenue. One of the nation’s largest revenue cycle managers serving labs reported that—over the four weeks beginning in the second week of March—revenue

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