COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION (As of April 2, 2020) Yesterday, North Carolina-based Cellex’s qSARS-CoV-2 IgG/IgM Rapid Test became the first coronavirus serology … [Read more...]
Coronavirus
FDA Takes Unprecedented Measures to Promote Rapid Development of Coronavirus Diagnostic Tests
March 17, 2020
The FDA is following a two-prong strategy to promote and expedite development and validation of a test capable of safe, rapid and reliable detection of novel coronavirus (COVID-19), the disease caused … [Read more...]
Coronavirus
CMS Develops Additional Code for Coronavirus Lab Tests
March 8, 2020
On March 6, the Centers for Medicare & Medicaid Services (CMS) announced a second Healthcare Common Procedure Coding System (HCPCS) code that can be used by laboratories to bill for certain … [Read more...]
Coronavirus
Top of the News: CMS Issues New Guidance for Laboratories Performing Coronavirus Testing
March 4, 2020
On Feb. 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) clearance for the first test approved in the US for detecting the novel coronavirus. Developed by the US … [Read more...]
FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test
March 2, 2020
Because the 2019 novel coronavirus outbreak was so unanticipated, there were no FDA-approved commercial products for it available in the US during its early days. On Jan. 28, the FDA unveiled its … [Read more...]
EMERGING TESTS
Standard Pathology Tests Outperform Molecular Subtyping in Bladder Cancer Tumor Classification
January 19, 2020
The deadliness of muscle invasive bladder cancer has made the development of new diagnostic and treatment methods imperative. One strategy involves the use of molecular genetic testing to subtype … [Read more...]
Emerging Tests: New Study Supports Feasibility of At-Home Urine Prostate Cancer Testing
January 2, 2020
One of the most challenging aspects of prostate cancer diagnosis is collecting urine samples from patients. In addition to being highly uncomfortable, post-digital rectal examination collection yields … [Read more...]
EMERGING TESTS
Zika Antibody Detection Tests Go from Emergency to Commercial Clearance
November 16, 2019
Over the past several years, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did … [Read more...]
EMERGING TESTS
Emerging Tests: New Genetic Tests May Be Better than PSA Screening in Assessing Prostate Cancer Risk
November 16, 2019
The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening based on their specific circumstances. The reason that the USPTF does not directly … [Read more...]
EMERGING TESTS
Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval
October 17, 2019
Next generation sequencing (NGS) data supporting resistance assessments is crucial to developing and gaining FDA clearance for new antiviral drugs and related companion diagnostic tests (CDx). Now the … [Read more...]
