Diagnostic Tools News and Resources for Healthcare

FDA approves Roche’s self-collected HPV tests

May 16, 2024 - On Wednesday, May 15, 2023, Roche announced that the United States FDA has approved the company’s human papillomavirus (HPV) self-collection solution, making it the first HPV self-collection test approved in the US. The company claims that this approval and future availability of this solution will help expand access to HPV screenings and may...

FDA takes actions to ensure the safety, effectiveness of LDTs

May 01, 2024 by Veronica Salib

Earlier this week, on April 29, 2024, the United States FDA issued a press release announcing its actions toward ensuring the safety and effectiveness of laboratory developed tests (LDTs). According...

NIH Launches Cancer Screening Research Network for Early Detection

February 23, 2024 by Veronica Salib

On Wednesday, February 21, 2024, the NIH launched a clinical trial network for evaluating new cancer detection technologies or methods called the Cancer Screening Research Network (CSRN), which will...

FDA Launches Programs to Reduce Risk of Cancer Biomarker Testing

June 26, 2023 by Veronica Salib

Last week, on June 20, 2023, the United States Food and Drug Administration (FDA) launched a pilot program to reduce the risk of laboratory-developed tests to identify cancer biomarkers. The program...

FDA Requires Anaphylaxis Warning for All Allergenic Extracts

March 14, 2023 by Veronica Salib

On March 3, 2023, the FDA issued a safety communication, announcing that it would require and approve changes to prescribing information labels for all allergenic extracts. The new labels should...

The Importance of Delaying the Onset of Type 1 Diabetes with New Treatment

February 27, 2023 by Alivia Kaylor

With a new FDA-approved immunotherapy treatment designed to delay the onset of type 1 diabetes (T1D), patients — 8 years or older — can enjoy more years without the physical and financial burdens of living with...