Emerging Tests

How Laboratories Are Developing New Coronavirus Diagnostic Tests at Record Speed

The criticism leveled at the Food and Drug Administration (FDA) over the lack of diagnostic tests for COVID-19 in the U.S. belies the unprecedented speed with which new coronavirus tests are reaching … [Read more...]

Testing Trends

USPSTF Recommends Hepatitis C Virus Infection Screening for All Adults

In response to a spike in hepatitis C virus (HCV) infection cases among young adults, the U.S. Preventive Services Task Force (USPSTF) revised its guidance and is now recommending that all adults, not … [Read more...]

FDA Watch

FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices

On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [Read more...]

REIMBURSEMENT

Billing & Coding: CMS Sets Rules for Medicare Coronavirus Testing Reimbursement with Private Payors Expected to Follow Suit

Good news for labs that are testing Medicare patients for the SARS-CoV-2 virus that causes coronavirus using the Centers for Disease Control and Prevention (CDC) 2019 Real Time RT-PCR Diagnostic Test … [Read more...]

Coronavirus

Reimbursement: Congress Calls on Insurers to Cover Coronavirus Testing without Charging Patients

As labs scramble to come up with a coronavirus detection assay and CMS creates a billing and coding regimen, Congress is working to ensure that private payors provide coverage of SARS-CoV-2 testing. … [Read more...]

FDA

LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims

The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict patients' responses to medications. It began in 2018, when the FDA warned consumers and … [Read more...]


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