TAG:
lab testing
March, April Patient Visits Drop at Virginia Physician Group and Lab
By Joseph Burns | From the Volume XXVII No. 8 – June 1, 2020 Issue
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…
California Research Team Analyzes Performance of 12 Serological Tests
By Joseph Burns
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 compa…
FDA Replaces March 16 Serology COVID-19 Rules
By Joseph Burns | From the Volume XXVII No. 7 – May 11, 2020 Issue
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…
Expert Offers Comments on FDA and Revised Serology Test Rules
By Joseph Burns | From the Volume XXVII No. 7 – May 11, 2020 Issue
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…
New Lab Revenue Source: COVID-19 Worker Screening
By Joseph Burns | From the Volume XXVII No. 7 – May 11, 2020 Issue
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…
California Research Team Analyzes Performance of 12 Serology Tests
By Joseph Burns | From the Volume XXVII No. 7 – May 11, 2020 Issue
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…
Companies Saw Big Drop in Lab Revenue from Mid-March
By 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 c…
Lab, Path Finances Crash; Next Test Wave: Serology
By Robert Michel | From the Volume XXVII No. 6 – April 20, 2020 Issue
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 …
From Mid-March, Labs Saw Big Drop in Revenue
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
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…
Labs May Qualify for Relief Under New Federal Laws
By Joseph Burns | From the Volume XXVII No. 6 – April 20, 2020 Issue
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…
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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