Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
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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
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
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Has Your AI Been Validated?
Many artificial intelligence-based medical devices have not undergone clinical validation—but what does this mean for the lab?
Diagnostics Pipeline: Recent FDA Approvals Aim to Make HPV Testing for Women More Accessible
Expansion of use for two assays gives patients the option to self-collect specimens at home and in the clinic, which may help address gaps in screening
Diagnostics Pipeline: Scientists Ask Agency to Rescind Approval for Opioid Management Test
Experts—including those in genetics and device regulation—say the AvertD assay did not predict risks of abuse ‘any better than chance’
Diagnostics Pipeline: Company Receives NIH Grant to Develop Test for Type 1 Diabetes Progression
NIH grant awarded to Metabolon is the first phase of what could be a three-year grant, according to a company official
Diagnostics Pipeline: Startup Women’s Health Lab Receives $4M in Federal Grants
The grants, which include $3 million from the NIH and $1 million from the NSF, will help the company develop point-of-care tests
Lab Company Takes Rare Step to Promote Heart Disease Test
Publishing peer-reviewed studies to tout the economic benefits of medical devices is fairly commonplace, but rare for a laboratory company
FDA’s Breakthrough Designation Now Includes Health Equity Provision
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
