Genetic Testing

AMP Survey Finds that Inadequate Reimbursement Hinders Use of Molecular Diagnostics

Inadequate reimbursement is hindering utilization of molecular testing. That is the conclusion of a new survey from the Association of Molecular Pathology (AMP). Survey respondents also suggested that … [Read more...]

FDA Watch

First De Novo Clearance Signals that Premarket Pathway Is Open for COVID-19 Tests

Just over a year ago, the U.S. Food and Drug Administration (FDA) granted its first Emergency Use Authorization (EUA) for a coronavirus test. On March 17, 2021, the test review process moved to a new … [Read more...]

Genetic Testing

New Study Supports Use of Liquid Biopsy Technology to Bolster MRI Accuracy in Cancer Treatment

Important new evidence has emerged supporting the capabilities of liquid biopsy to enhance the accuracy of magnetic resonance imaging (MRI) for cancer diagnosis and treatment. That evidence comes from … [Read more...]

Current Issue of DTET

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Emerging Tests

The Evolving COVID-19 Market: FDA Clears the Way for Asymptomatic Screening Products

A year after it came into being, the market for coronavirus diagnostics is dramatically evolving with the focus of growth inevitably shifting to products designed for serial screening of the … [Read more...]

Daily Update

Tests with EUA

COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test (m) = Multi-analyte Test) Date Manufacturer(s) Test … [Read more...]

Diagnostic Testing and Emerging Technologies Newsletter Archive

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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

New Genomic Test Can Eliminate Up to One-Third of Medically Unnecessary Prostate Cancer Biopsies

Genetic testing has been shown to be effective in detecting prostate cancer and eliminating the need for unnecessary biopsies. And even though the current commercial market for such tests is crowded, … [Read more...]

Industry Trends

Inside the Diagnostics Industry: Guardant Health Takes Aim at Exact Sciences’ Leadership of Colorectal Cancer Market

Colorectal cancer is a key segment of the U.S. and world diagnostics market that generates billions of dollars in test revenues per year and is projected to grow at an annual rate of nearly 6 percent. … [Read more...]