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...]
Genetic Testing
AMP Survey Finds that Inadequate Reimbursement Hinders Use of Molecular Diagnostics
May 5, 2021
FDA Watch
First De Novo Clearance Signals that Premarket Pathway Is Open for COVID-19 Tests
May 5, 2021
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
May 1, 2021
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
May 1, 2021
Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download DTET content: I agree that I am the the only person who is accessing my … [Read more...]
Emerging Tests
The Evolving COVID-19 Market: FDA Clears the Way for Asymptomatic Screening Products
April 4, 2021
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
April 2, 2021
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
April 1, 2021
By clicking on any of the links below you agree that you are the the only person who is accessing your single user DTET subscription license and that you are not sharing your username and password … [Read more...]
Testing Strategy
FDA to SARS-CoV-2 Test Developers: Evaluate Impact of Genetic Mutations on Test Performance
March 23, 2021
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
March 23, 2021
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
March 23, 2021
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...]
