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COVID-19 Molecular Testing
Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome—the individual’s genetic code and how their cells express their genes as proteins—by applying molecular biology to medical testing. The technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients.
As the primary clinical manifestation of COVID-19 is a respiratory illness, PCR tests are generally used to test samples obtained from the upper or lower respiratory tract. Appropriate upper respiratory sample types include a nasopharyngeal swab or a throat swab.
Currently there are two types of diagnostic tests— molecular tests, such as RT-PCR tests, that detect the virus’s genetic material, and antigen tests that detect specific proteins from the virus.
NorDx Lab Started COVID Preparation in 2019
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…
Why Labs Operate in a ‘Duality’ during Pandemic
HAS IT OCCURRED TO MANY OF YOU THAT YOUR CLINICAL LABORATORIES today must operate in what I will describe as an operational “duality”? On one side, your lab must deal with COVID-19 testing. This is true whether your lab performs molecular SARS-CoV-2…
Memphis Path Lab Pivots to COVID, Pooled Testing
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
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…
December 7, 2020 Intelligence: Late-Breaking Lab News
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 …
California Builds Its Own COVID Lab: $25 Million or $1.7 Billion?
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…
IVD Firms Report Robust Growth In Third Quarter Financial Reports
FOR THE BIGGER IN VITRO (IVD) COMPANIES, the third quarter (Q3) ending Sept. 30 was a time when diagnostic sales rose—molecular testing is skyrocketing, actually—while other corporate divisions continued to lag amid the COVID-19 pandemic. …
Medicare COVID Test Coding May Become a ‘Logistical Nightmare’
STARTING JAN. 1, 2021, clinical laboratories performing COVID-19 tests using high-throughput systems for Medicare patients must comply with a complex new coding rule when submitting claims for these tests. The federal Centers for Med…
Medicare COVID Test Payments to Be Cut Starting Jan. 1
This is an excerpt of a 1,9842-word article in the October 26, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Starting Jan. 1, CMS will lower the Medicare COVID test payment to $75 when labs with “high-throughp…
Lab Leaders Say COVID-19 Tests Needed in 2021
How long into the future will clinical laboratories need to offer COVID-19 tests on a large scale? That is the number one question confronting labs in every region of the United States. Last week, three nationally-known lab CEOs answered that question during the general session of the Virtual E…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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