Tests broaden access to accurate, easy-to-use diagnostics for patients in a decentralised setting Roche has been granted US ...

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating ...

The Medical Genetics Multiomics Laboratory (MGML) is an academic clinical genetic testing laboratory from Baylor College of Medicine. The MGML supports the academic mission of Baylor College of ...

During this process, a CLIA-accredited diagnostics laboratory adapts the experimental test into a version that reliably works under the strict conditions in a clinical lab. CLIA is a rigorous ...

During this process, a CLIA-accredited diagnostics laboratory adapts the experimental test into a version that reliably works under the strict conditions in a clinical lab. CLIA is a rigorous ...

US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels: Basel Thursday, January 23, 2025, 09:00 Hrs [IST] Roc ...

a leader in Personalized Therapy Decision Support and Precision Drug Development, today announced that its computational laboratory in Franklin, Tennessee, has obtained certification of compliance ...

More than 1 million curable sexually transmitted infections (STIs) are acquired every day worldwide in people 15-49 years old, most of which are asymptomatic.1 FDA CLIA-waived tests broaden access to ...

LDTs were certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and regulated by the Centers for Medicare & Medicaid Services, which did not require the tests to show ...

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, diagnosis, and ...