Genetic Testing

Three Common PGx Compliance Traps for Laboratories to Avoid

By Adam M. Walters Walters Law, P.C. In recent years, many clinical laboratories have started offering Pharmacogenetics Testing (PGx) to assist physicians in avoiding prescribing medication … [Read more...]

CLINICAL GUIDELINES

CDC Updates Guidelines on Laboratory Testing for Sexually Transmitted Infections

On July 22, the US Centers for Disease Control and Prevention (CDC) revised its guidelines for the diagnosis and treatment of sexually transmitted infections (STI), including with regard to how to … [Read more...]

EMERGING TESTS

New Evidence Supports Suitability of Antigen Testing for COVID-19 Screening

Not perfect, but good enough. That is the basic theory for using rapid antigen tests for COVID-19 surveillance even though they are less accurate than molecular assays in detecting the SARS-CoV-2 … [Read more...]

Emerging Tests

New Evidence Supports Suitability of Antigen Testing for COVID-19 Screening

Not perfect, but good enough. That is the basic theory for using rapid antigen tests for COVID-19 surveillance even though they are less accurate than molecular assays in detecting the SARS-CoV-2 … [Read more...]

Testing Strategy

CDC/NIH Team with Local Health Authorities to Promote, Evaluate Home COVID-19 Testing

As the COVID-19 crisis drags on, the primary focus of the federal government’s testing strategy continues to shift from medical diagnosis and treatment to broad testing of the asymptomatic for … [Read more...]

Testing Strategy

FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance

Evolution and mutation of SARS-CoV-2 virus has made COVID-19 diagnosis a moving target. On Feb. 22, 2021, the U.S. Food and Drug Administration issued new guidance telling developers of SARS-CoV-2 … [Read more...]

Emerging Tests

FDA Clears the Way for Serial Use At-Home and Point-of-Care Asymptomatic Screening Tests

At-home and point-of-care (POC) serial testing for purposes of screening the asymptomatic is, arguably, the most promising, long-term market for new SARS-CoV-2 diagnostics. On March 16, 2021, the U.S. … [Read more...]

Testing Strategy

The Biden Administration Initiates New Plan for National COVID-19 Testing

As with any other aspect of public life, the philosophy and views of the individual occupying the White House ultimately impact the direction of healthcare and diagnostics in the U.S. However, when a … [Read more...]

Testing Trends

Report Analyzes Federal Health Programs’ COVID-19 Testing Efforts in First Months of Pandemic

The COVID-19 outbreak caught the country and the world totally off guard. And even as the pandemic intensifies, the lessons from those first crucial months hold the key to managing not only … [Read more...]

Innovation

New Saliva-Based CRISPR Smartphone Assays May Fill Need for Mass and Rapid COVID-19 Testing

One of the few positive things to come out of this deadly global pandemic is how it has accelerated the pace of diagnostic innovation to hyperdrive levels. The latest example of this phenomenon is the … [Read more...]


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