Weekly Enforcement Report: Drug Testing Fraud Dominates
Last week’s three key cases included two involving drug testing that was either medically unnecessary, or not provided at all.
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Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel
While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.
Quest Expands into MRD Liquid Biopsy with Haystack Oncology Buy
The acquisition of the Johns Hopkins spin out and its liquid biopsy ctDNA test will significantly strengthen Quest’s oncology offerings.
FDA Releases Recommendations for Safe Use of At-Home COVID-19 Tests
On March 18, the U.S. Food and Drug Administration (FDA) released a Safety Communication about the dangers of improperly used FDA authorized at-home COVID-19 tests. The agency also reminded the public that these tests should be safely stored away from children and...
Labs in Court Weekly Roundup
Enforcement actions involving health care fraud were again dominant over the past two weeks, based on information from the U.S. Department of Justice (DOJ) and state agencies. Of the key court cases involving the lab and/or health care industry from March 10-21,...
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...
FDA Orders LuSys and Celltrion to Recall Unauthorized COVID-19 Rapid Tests
This week, two companies announced Class I recalls, the most serious kind, for COVID-19 antigen and antibody tests that have reached the US market without FDA Emergency Use Authorization (EUA) or 510(k) clearance. San Diego-based LuSys Laboratories is recalling...
