CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
Already a member? Log in here
Laboratory Industry Report
Keeps You Up-to-Date on Lab Business and Competitive Strategy, Market Trends and Opportunities, and M&A and Investment Activity in Today’s Diagnostic Lab Industry
Subscribe today for access to
Articles and Reports
FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
Already a member? Log in here
Dx Deals: Veracyte Acquires Convergent Genomics for up to $180 Million
The deal gives the oncology-focused Veracyte a boost in bladder cancer detection
Already a member? Log in here
FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
Already a member? Log in here
ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
Already a member? Log in here
Dx Deals: Labcorp Buys Select Assets of Empire City Laboratories
The national lab giant swiftly merged Empire City’s operations into its own
Already a member? Log in here
Recent MD Labs Ruling Has Implications for Test Requisitions and Commissions
A federal appeals court upheld the idea that clinical laboratories can rely on physician orders to justify medical necessity
Already a member? Log in here
OIG Report on Lab Testing Should Prompt Compliance Review
Genetic testing now accounts for 43 percent of all Medicare Part B laboratory spending
Already a member? Log in here
Overturning of Molecular Test Coverage Denials Varies Widely, According to UCSF Study
Research into independent medical review data in four states show payers’ internal policies affect rates of overturns
Already a member? Log in here
Dx Deals: Fulgent Genetics Scores Two Laboratories in a Single Deal
It is acquiring Bako Diagnostics and StrataDx for a combined $55.5 million
Already a member? Log in here
FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
Already a member? Log in here
Up Next for Labs: PAMA Reporting Window Opens May 1
Cuts to reimbursement rates under PAMA have been pushed back again by Congress, this time to January 2027
Already a member? Log in here
PAMA Delay Proposed Until 2027 Under a New Federal Spending Bill
However, attorney Danielle Sloane urges labs to be proactive about potential PAMA reporting requirements on Jan. 31 if the bill doesn’t pass quickly
Already a member? Log in here
