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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
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...
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...
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...
Labcorp Enters Comprehensive, Long-Term Lab Relationship With Ascension
BURLINGTON, NC — (BUSINESS WIRE) — Labcorp (NYSE: LH), a leading global life sciences company, today announced that it has entered into agreements to create a comprehensive strategic relationship with Ascension, one of the nation’s leading Catholic and non-profit...
Ten Indicted for Health Care Kickbacks
Ten people, including two medical doctors, have been indicted in a $300 million health care fraud, announced U.S. Attorney for the Northern District of Texas Chad E. Meacham. The defendants—who stand accused of accused of conspiracy to commit health care fraud,...
Medicare Expands Coverage of LCDT Lung Cancer Screening
No cancer is more deadly than lung cancer. But early detection can save lives and head off costly and invasive treatment. With this in mind, the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) expanding coverage for...