Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
FDA-dtet
Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
Recent FDA Approvals Show Growing Sophistication of At-Home Tests
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.
The Diagnostics Pipeline: FDA Approves First Ever Fentanyl Test Strips for OTC Use
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
FDA’s LDT Proposal Raises Questions About Clinical Validity
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls
With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.
The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs
New program aims to provide greater transparency on the recommended performance characteristics of such tests.
The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
The Diagnostics Pipeline: FDA Issues Groundbreaking Clearance for an RSV Vaccine
In early May, GSK’s Arexvy became the first RSV vaccine to be cleared by the FDA for use in the US in adults aged 60 and up.
The Diagnostics Pipeline: FDA Unveils Plan to End COVID-19 Test Emergency Use Authorizations
On March 27, the agency released a new guidance document to help test developers make the transition to full approval.
