Molecular Testing for Urinary Tract Infection (UTI): 2020 Update on Clinical Utility and Reimbursement Trends

Molecular tests are becoming more routine as diagnostic tools, with many now covered by Medicare and commercial insurers. Advantages of molecular tests based on PCR technology include their ability to identify uropathogens traditionally missed by culture-based tests.

Driven by urgent, unmet analytical and clinical care needs, the adoption of the rapid molecular test—particularly RT-PCR for urinary tract infection control and treatment—has important implications.

Medical Laboratory Test Data and Clinical Lab 2.0 are Powering Dashboards That Help Providers Mitigate COVID-19 and Improve Population Health

Coronavirus informatics companies are drawing clinical laboratory test data out of the shadows and into the light and compiling it into critical bioinformatics resources What better example do we have that clinical laboratory test data is critical to population health than the current COVID-19 pandemic? Medical laboratory scientists, bioinformatics developers, and government healthcare leaders are using lab test data to track the disease’s rate of infection, and through information system...

Case Studies in Clinical Laboratory Test Stewardship: The Financial and Clinical Impact of Clinical Decision Support in Hospital Laboratories

This white paper – the third in a three-part series developed in collaboration with Mayo Clinic Laboratories and Change Healthcare – provides frontline perspective and commentary from experts and physicians on the application and value of decision support in the laboratory. It also includes early-adopter proof points from hospital laboratories that have successfully implemented third-party decision support to achieve their stewardship goals, including EHR interventions and ongoing monitoring of utilization.

FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...

Mobile Device Software Companies Are Developing Smartphone Apps That Use Artificial Intelligence to Test for COVID-19, Potentially Bypassing the Clinical Laboratory Altogether

This is another example of technology companies working to develop medical laboratory testing that consumers can use without requiring a doctor’s order for the test Here’s new technology that could be a gamechanger in the fight against COVID-19 if further research allows it to be used in patient care. The goal of the researchers involved is to enable individuals to test for the SARS-CoV-2 coronavirus from home with the assistance of a smartphone app enhanced by artificial intelligence (AI)....

FDA’s Regulatory Hurdles ‘Paralyzed’ Efforts of CLIA-Certified Clinical Laboratories to Offer Alternatives to CDC’s Flawed COVID-19 Test

Washington Post investigation outlines scientists’ frustrations in the early days of the pandemic, as they worked to deploy laboratory-developed tests for the novel coronavirus In the wake of the failed rollout of the Centers for Disease Control and Prevention’s (CDC) COVID-19 diagnostic test last February, many CLIA-certified academic and public health laboratories were ready, and had the necessary resources, to develop their own coronavirus molecular diagnostic tests to help meet the...