New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...

Laboratories that perform tests on human materials for the purpose of diagnosis are considered laboratories under the Clinical Laboratory Improvement Amendments (CLIA) and must receive CLIA ...

FDA clearance, panel choice, accuracy, on-site speed and supplier reliability for compliant workplace programs.

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The US Food and Drug Administration (FDA) on Tuesday finalized two guidances providing recommendation for diagnostics makers looking to submit Clinical Laboratories Improvement Amendments (CLIA) ...

Nursing homes will be required to have Clinical Laboratory Improvement Amendments (CLIA) waivers to perform COVID-19 point-of-care tests. As a result, the Centers for Medicare & Medicaid Services is ...

PALO ALTO, Calif.--(BUSINESS WIRE)--Theranos, Inc. (Theranos) today announced that its test and Theranos test system for the herpes simplex 1 virus IgG (HSV-1), which was cleared by the U.S. Food and ...

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellworks Group, Inc., a leader in Personalized Therapy Decision Support and Precision Drug Development, today announced that its computational laboratory ...