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
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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
Diagnostics Pipeline: More AI-Reliant Platforms Being Approved by the FDA
Such assays rely more on imaging and computer power than tissue samples to make diagnoses.
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.
