TAG:
lab testing services
March, April Patient Visits Drop at Virginia Physician Group and Lab
DURING THE CARONAVIRUS PANDEMIC,Ā gastroenterology and otherĀ physician groups with in-houseĀ medical laboratoriesālike most medicalĀ practices and clinical laboratories in theĀ United Statesāhave seen a sharp drop inĀ patient visits and specimen volume. That drop occurred at the same timeĀ ga…
FDA Replaces March 16 Serology COVID-19 Rules
CEO SUMMARY: In the rush to allow companies and clinicalĀ laboratories to develop, validate, and bring to market serologicalĀ tests for COVID-19, the federal Food and Drug AdministrationĀ issued rules on March 16 that eased its requirements for theseĀ new assays. Because of the la…
Expert Offers Comments on FDA and Revised Serology Test Rules
CLINICAL LABORATORY DIRECTORS areĀ asking what caused the federal FoodĀ and Drug Administration (FDA) toĀ issue a highly questionable policy in MarchĀ to allow serological tests for SARS-CoV-2Ā and then change that policy seven weeksĀ later. Under a policy the agency issuedĀ March…
New Lab Revenue Source: COVID-19 Worker Screening
CLINICAL LABORATORIES have a newĀ revenue-generating opportunity,Ā as some states relax stay-at-homeĀ rules: Many employers are likely to seekĀ COVID-19 screening tests for employeesĀ returning to work to detect the presenceĀ of the new coronavirus. This new source of lab specimens andĀ revenue gi…
From Mid-March, Labs Saw Big Drop in Revenue
CEO SUMMARY: In response to the coronavirus outbreak,Ā patients stopped seeing their doctors for routine care and hospitalsĀ ceased doing elective services. With fewer test referrals,Ā clinical labs and pathology groups were hit with a substantialĀ decline in revenue. One of t…
Chicago Lab Launches LDT, Finds 20% Positive
CEO SUMMARY: After seeing the novel coronavirus spreadĀ quickly in China, staff in the Department of Pathology andĀ Laboratory Medicine developed a test to identify the pathogenĀ in patients in Chicago and its suburbs. With the CDCās assayĀ in hand, it started work on its ow…
Northwell Lab Team Validates COVID-19 Test on Fast Timeline
CEO SUMMARY: Clinical labs are working with haste to test for the novel coronavirus, also called nCoV and SARS-CoV-2. Their efforts to prepare for high capacity testing for viral respiratory illness include validating molecular tests for the newly-identifie…
Northwell and Memorial Health: A Tale of Two Labs
Something very unusual happened inĀ thisĀ issueĀ ofĀ TheĀ DarkĀ Report. We analyzed the entirely opposite fates of two clinical laboratories owned by different healthcare systems. With apologies to author Charles Dickens and his opening sentence in his novel, a Tale of Two Cities, it c…
Vanderbilt Lab Uses Predictive Medicine to Improve Care
> CEO SUMMARY: The integrative diagnostics lab at the Vanderbilt University Medical Center aims to use sophisticated diagnostics to advance the use of precision medicine testing to improve patient care and to do so at an affordable cost. As part of these efforts, the lab staff …
Lawsuits Alleging Overcharges to Proceed in Two Courts in 2020
CEO SUMMARY: Two lawsuits filed in federalĀ courts against Laboratory Corporation of America and Quest Diagnostics may have consequences for the entire lab industry. The plaintiffs are patients who allege that the two defendant lab companies charged them as much as 10 times more than what …
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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