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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test
On Jan. 27, BioFire Defense's COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than...
Leader in Brain Health Sector Achieves Key Certification
ST. LOUIS, MO — C2N Diagnostics has earned ISO 13485:2016 certification for its quality management system. In late 2020 C2N launched the PrecivityAD™ test, an innovative blood test intended for use with patients with cognitive impairment. The test aims to help...
Newly Identified Protein May Help Diagnose Ulcerative Colitis
An international research collaboration has discovered a potential new diagnostic marker for ulcerative colitis in a trans-ethnic analysis of Japanese and White patients. The finding could lead to the development of non-invasive, diagnostic blood test to both...
Blood-Based Test Uses Lipid Profiles to Detect Early-Stage Lung Cancer
Research team creates a promising new mass spectrometry-based blood lipid test.
MRI May Lower Breast Cancer Deaths from Variants in 3 Genes
Annual MRI screenings starting at ages 30 to 35 may reduce breast-cancer mortality by more than 50 percent among women who carry certain genetic changes in three genes, according to a comparative modeling analysis published Feb. 17, 2022, in JAMA Oncology. The...