Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
Genomic Tests for Prostate Cancer Risk Stratification Are Now Covered
A newly finalized local coverage determination from MAC Palmetto GBA sets out coverage criteria for two applications of these tests.
Review: NIPS Accurate in Detecting Most Common Genetic Abnormalities
A systematic evidence-based review from the ACMG shows NIPS tests are an effective screening tool for general-risk pregnancies.
Apple Employee Uprising Shows Dangers of Ending Remote Work
Lab employees who’ve worked from home may be less than willing to return to the facility, if the situation at Apple is anything to go by.
Plunging Test Rates Threaten Efforts to Detect New SARS-CoV-2 Variants
Despite the emergence and rise of new Omicron variants, COVID-19 testing has declined as much as 90 percent, according to some reports.
Blood-Based Alzheimer’s Tests Have Officially Arrived
Recent developments suggest that we are on the precipice of a new age offering expanded options for Alzheimer’s diagnosis.
Telehealth Encounters Lead to More Follow-Ups than In-Person Visits
Recent study suggests those being treated for acute conditions are likelier to schedule follow-up appointments after telehealth visits.
Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
Does Race Affect Interpretation of Alzheimer’s Blood Test Results?
Researchers find that three out of four blood tests produced different results depending on if they were used for White or Black people.
HHS Tabs OraSure Technologies for COVID-19 School Testing
HHS will distribute OraSure’s InteliSwab COVID-19 rapid at-home antigen test kits to schools across the nation.
Could a Pacifier Replace Blood Draws for Babies in the NICU?
A recently developed bioelectronic tool could make health monitoring less invasive for babies in newborn intensive care units.
