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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
Fraud Trial of Theranos CEO Is Back on Track
After several delays, the trial of former Theranos CEO Ramesh "Sunny" Balwani on charges of fraud and wire fraud resumes today. The prosecution evidence includes records showing that Theranos voided lab test results to cure CLIA deficiencies cited in January 2016....
MRI Innovation Makes Cancerous Tissue Light Up and Easier to See
A new form of magnetic resonance imaging (MRI) that makes cancerous tissue glow in medical images could help doctors more accurately detect and track the progression of cancer over time. The innovation, developed by researchers at the University of Waterloo,...
Saliva Testing for COVID-19 Quicker, Safer than Nasal Swabs
WASHINGTON, DC — Genetic testing of saliva samples identifies the SARS-CoV-2 virus more quickly than testing of nasal swabs, according to research published March 21 in Microbiology Spectrum, a journal of the American Society for Microbiology. “That is important...
New Assay Could Make Allergy Testing Easier and Less Painful
Diagnosing allergies is difficult and cumbersome. Current skin-prick tests are painful, time-consuming, and carry the chance of the patient having a dangerous allergic reaction. But a new assay from researchers at the University of Bern and Inselspital, Bern...
NIH Sees Budget Increase by $2 Billion
On March 15, President Biden signed the Consolidated Appropriations Act, 2022 into law, an omnibus bill that sets the budgets for all federal agencies for the rest of FY2022. The bill includes a $2 billion increase for the National Institutes of Health (NIH),...
New Smartphone App Encourages People to Seek Therapy for Heart Disease
Smartphone apps can already help manage many aspects of our health, from tracking physical activity to suggesting healthy eating options to monitoring heart rate. Now, a new app has been developed that predicts an individual’s genetic risk for coronary artery...
Quest and Walmart Partner to Make Consumer Lab Tests Accessible Online
Even before the pandemic, labs and major retailers have been partnering to make lab tests more accessible for consumers. Under a recently announced collaboration, Quest Diagnostics, the nation’s largest lab will work with retail giant Walmart to enable customers to...
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
