TAG:

laboratories

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 la…

Read More



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…

Read More



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…

Read More



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 te…

Read More



Clinical Labs Step Up, But Serious Problems Are Ahead

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 th…

Read More



Lab, Path Finances Crash; Next Test Wave: Serology

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 …

Read More



From Mid-March, Labs Saw Big Drop in Revenue

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 t…

Read More



Labs May Qualify for Relief Under New Federal Laws

CEO SUMMARY: After routine testing and specimen volume declined last month, so too did the associated revenue. In response, clinical laboratories and anatomic pathology groups want to bolster their finances quickly or risk incurring more financial damage to already-fragile…

Read More



Italy’s SARS-CoV-2 Outbreak Brings Out Best in Clinical Labs

CEO SUMMARY: Italy was one of the first countries outside of China to experience an explosive outbreak of COVID-19 and its northern provinces were hit hardest by this novel coronavirus. In this exclusive interview with THE DARK REPORT,…

Read More



DOJ Says Georgia Man Got Kickbacks for COVID-19 Tests

JUST WEEKS AFTER THE FIRST CASES OF SARS-CoV-2 appeared in the United States, federal prosecutors filed criminal charges in a COVID-19 lab test fraud scheme. Erik Santos, 49, of Braselton, Ga., was charged with conspiracy to defraud federal and private healthcare programs by submitting fraudule…

Read More



How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Need A Group Membership? Company Discounts are Available!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

Powered by Americaneagle.com

Hosted by Americaneagle.com, Inc.