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clinical laboratory industry
FDA Says 8 of 11 Tests Fail in Serology Test Review
This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review,…
COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail
CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from…
Health Insurers Push Back On COVID-19 Test Claims
CEO SUMMARY: Under new federal laws, health insurers are required to pay for testing for the novel coronavirus without cost-sharing, prior authorization, or medical management limits, but insurers are questioning these COVID-19 lab test bills and denying many of the claims, a healthca…
June 22, 2020 Intelligence: Late-Breaking Lab News
As they scramble to respond to the COVID-19 pandemic, federal officials in multiple agencies are purchasing equipment and supplies from vendors with dubious credentials and little operating history. In recent days, Pro-Publica reported “a fledgling Texas company was paid $7.3 mil…
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs
This is an excerpt of a 1,209-word article in the June 1, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to man…
Where Does COVID-19 Take Clinical Labs Next?
It is easy to say that the current COVID-19 pandemic is a global event without precedent in human history. After all, what other event has caused airline travel to drop by 95%, ended all professional and amateur sports events worldwide, shuttered Broadway theaters and movie cinemas, closed all no…
COVID-19 Pandemic Erodes Cash Flow at Clinical Labs
CEO SUMMARY: Every day, national news headlines scream about the shortage of SARS-CoV-2 lab tests needed to manage the COVID-19 pandemic. Recently, national news coverage has begun focusing on concerns about inaccurate or unreliable COVID-19 serology tests. But the story being…
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 per…
March, April Patient Visits Drop at Virginia Physician Group and Lab
DURING THE CARONAVIRUS PANDEMIC, gastroenterology and other physician groups with in-house medical laboratories—like most medical practices and clinical laboratories in the United States—have seen a sharp drop in patient visits and specimen volume. That drop occurred at the same time ga…
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…
CURRENT ISSUE
Volume XXVII No. 9 – June 22, 2020
THE NEWS ON THE SEROLOGICAL TEST FRONT is discouraging, even bleak, as THE DARK REPORT analyzes the outcome of the FDA’s own review of 11 tests previously listed as marketable. Only three tests passed the review, and yet a quality control expert consulted by THE DARK REPORT has dim views of the FDA’s testing operation, leading to even more doubts. Also, health insurers are scraping away at mandated COVID-19 test reimbursements, leaving lab revenues once again at their mercy.
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