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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
In (Digital) Defense of HIPAA
How clinical laboratories and pathology groups can ensure that their digital pathology and AI workflows are HIPAA-compliant
Preserving Patient Privacy in a Digital Era
What labs need to know about keeping patients’ data safe when using digital pathology and artificial intelligence-based solutions
Expert Q&A: Labs Must Take a Greater Role in Guiding Clinicians About Abnormal Data
Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists
FDA Watch: Could Guardant Health’s Colon Cancer Assay Be a Blockbuster?
The company is hiring at least 100 sales representatives this year to spread awareness and uptake of its recently FDA-approved Shield test
At-Home Genetic Testing: The Good, The Bad, and The Ugly
Direct-to-consumer (DTC) genetic testing has risen in popularity in recent years—but is it all it’s cracked up to be?
Laboratory Genetic Counselors: A Valuable Investment
As the field of genetic testing grows, genetic counselors can help labs meet patients’ needs and keep up with new developments
Private Payer Reimbursement for Genetic Testing Hinges on Clinical Utility
Two revenue cycle management experts offer tips for clinical labs to improve coverage decisions for genetic tests
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
Dx Deals: Quest Makes Big North American Expansion with LifeLabs Acquisition
The roughly $1 billion deal will boost the company’s annual revenue by about 7 percent, and will give Quest a stronger presence in Canada
Loper Bright Renews Interest in the VALID Act
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
