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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
Feds Target Fraudulent Billing of Genetic Cancer Tests
False ordering and billing of cancer genetic (CGx) tests has become a favorite target for federal fraud enforcers, with the U.S. Department of Justice (DOJ) reporting two notable convictions in the closing months of 2021. On Nov. 17, a 57-year-old former lab sales...
Healthy Growth Predicted for Global Aspiration & Biopsy Needles Market
According to a recently released report from market research company Research and Markets, the global aspiration and biopsy needles market is poised for solid growth over the next five years. The report valued the market at an estimated $879 million US for 2021 and...
Labcorp Completes Acquisition of Personal Genome Diagnostics
BURLINGTON, NC — Labcorp, a leading global life sciences company, announced Feb. 21 that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products....
Startup Awarded NIH Grant to Develop Endometriosis Test
OAKLAND, CA — NextGen Jane, a genomics startup generating big data for novel applications in molecular diagnostics and drug development for female reproductive disorders, announced that it has received the green light for the second phase of a Small Business...
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...