How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
Five strategies for lab leaders to focus on to tackle the challenges of today and ensure future success.
Standard 1910.1450 requires labs to have a chemical hygiene plan.
Approaching laboratory safety from a diversity, equity, inclusion, and accessibility perspective.
Artificial intelligence models have a valuable role to play in each phase of the total testing process.
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
While Roche has an early lead, Quest recently made key moves to improve its position in the AD patient-initiated blood testing market.
A settlement for kickback allegations, prison time for lab owners convicted of COVID-19 fraud, and 10x Genomics gets OK for lawsuit.
Key 2024 coding changes for laboratories and tips for ensuring proper implementation into chargemasters and fee schedules.