Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Newly Identified Protein May Help Diagnose Ulcerative Colitis
An international research collaboration has discovered a potential new diagnostic marker for ulcerative colitis in a trans-ethnic analysis of Japanese and White patients. The finding could lead to the development of non-invasive, diagnostic blood test to both...
Blood-Based Test Uses Lipid Profiles to Detect Early-Stage Lung Cancer
Research team creates a promising new mass spectrometry-based blood lipid test.
MRI May Lower Breast Cancer Deaths from Variants in 3 Genes
Annual MRI screenings starting at ages 30 to 35 may reduce breast-cancer mortality by more than 50 percent among women who carry certain genetic changes in three genes, according to a comparative modeling analysis published Feb. 17, 2022, in JAMA Oncology. The...
Financing to Advance Early Autism Diagnosis and Treatment in Children
ATLANTA, GA — (BUSINESS WIRE) — EarliTec Dx, Inc. (“EarliTec”), a digital health company developing novel diagnostic and therapeutic products for children with autism spectrum disorder (ASD) and early childhood vulnerabilities, announced today a $19.5 million...
COVID-19 Testing Company in Hot Water for Numerous Infractions
An Illinois-based COVID-19 testing company and its laboratory is facing lawsuits from two different states as well as investigations from several state and federal authorities after patient and employee complaints brought to light a number of problems. The Center...
Beyond the Pap Smear: New Methods to Improve Cytological Screening
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NIOSH Awards More than $5M to Address COVID-19 Related Challenges
The National Institute for Occupational Safety and Health (NIOSH) provided more than $5 million in extramural funding during fiscal year (FY) 2021 to 38 projects that address challenges related to the coronavirus disease 2019 (COVID-19) pandemic. This amount...
Digital Pathology Solutions Cut Whole-Slide Diagnosis Time by 26%
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Whatever Happened to Those Part B Lab Test Spending Reductions?
The Protecting Access to Medicare Act (PAMA) was supposed to significantly reduce Medicare Part B lab tests spending. But it hasn’t happened. In FY 2018 and 2019, the first two years under the PAMA system, Medicare payments under the Clinical Laboratory Fee...
Genomenon Awarded NIH Grant to Curate the Human Genome
Ann Arbor, MI — February 15, 2022 — Genomenon, Inc., an AI-driven genomics company, today announced that it was awarded a $1.7 million grant by the National Institutes of Health (NIH) through the Small Business Innovation Research (SBIR) program. The grant is to...
