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
NIH grant awarded to Metabolon is the first phase of what could be a three-year grant, according to a company official
Though not expected to drastically change the program, new component gives device makers another way to strengthen their submissions
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
Such assays rely more on imaging and computer power than tissue samples to make diagnoses.
Once confined to areas such as pregnancy testing, these assays can now be used to detect STIs and other health issues.
Approval for OTC use of a urine drug test that can be performed by non-CLIA facilities could help expand accessibility, expert says.
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.
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 agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
New program aims to provide greater transparency on the recommended performance characteristics of such tests.