TAG:
lab tests
January 19, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
Just days ago, the federal Food and Drug Administration (FDA) issued updated information about the COVID-19 tests it has authorized since early in the pandemic. As of Jan. 15, 2021, the agency had authorized a total of 317 tests for the SARS-CoV-2 coronavirus. Included in this total are 236 mo…
UK Postpones Mass COVID Testing Plan Due to Questions of Accuracy
By Robert Michel | From the Volume XXVII, No. 18 – December 28, 2020 Issue
IN THE UNITED KINGDOM, A MASS COVID-19 TESTING PLAN called “Operation Moonshot” is on hold until at least the end of January. Under the plan, health ministers sought to increase daily SARS-CoV-2 testing from 430,000 to 10 million Englanders per day. …
NorDx Lab Started COVID Preparation in 2019
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testin…
One Genetic Test CPT Code Earns ‘Fraudomatic’ Title
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CEO SUMMARY: Several genetic testing companies have noticed that some of the nation’s Medicare Administrative Contractors (MAC) pay about $2,000 for test claims billed with CPT code 81408. From 2018 through and 2019, the number of 81408 claims rose dramatically at just two of thes…
Memphis Path Lab Pivots to COVID, Pooled Testing
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency …
NorDx Lab Started to Prepare for COVID-19 Testing in 2019
By Joseph Burns | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…
CMS Sends Cease/Desist Letters to Labs Lacking CLIA Certificates
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
CLINICAL LABORATORIES DOING COVID-19 TESTING and lacking the proper CLIA certificates to do so are receiving cease-and-desist letters from the federal Centers for Medicare and Medicaid Services (CMS). The first letters were sent on Aug. 12 and le…
December 7, 2020 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVII, No. 17 – December 7, 2020 Issue
Supply chain issues associated with the SARS-CoV-2 pandemic are about to disrupt testing for other infectious diseases, ranging from strep throat and pneumonia to sexually-transmitted diseases (STDs). That was one important finding from the American Society for Microbiology’s (ASM) November …
Pooled COVID Testing a Success for New York Hospital Lab
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
This is an excerpt of a 1,552-word article in the November 16, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Pooled COVID testing helps the clinical lab staff at the hospital in Saratoga Springs, N.Y., do …
California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?
By Robert Michel | From the Volume XXVII, No. 16 – November 16, 2020 Issue
CEO SUMMARY: California dropped a bomb on the state’s existing network of hospital labs and independent clinical labs when, on Oct. 30, it announced it had built and opened a new laboratory facility in Valencia designed to perform 150,000 COVID-19 tests per day. Now, existing labs…
CURRENT ISSUE

Volume XXVIII, Number 2 – February 8, 2021
VARIANT SEQUENCING FOR COVID-19 is the next big opportunity for clinical labs and pathology groups. It is currently being undertaken by large labs and academic medical centers, but local labs could be next. Also, The Dark Report reports on a highly successful collaboration on a COVID test between a university and a commercial company.
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