On Aug. 2, 2021, the FDA published the long-awaited final rule updating its “intended use” regulations for medical devices and drugs. Here’s a quick briefing of the new rules, which took effect on … [Read more...]
FDA Watch
Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs
September 13, 2021
DX Deals
Labcorp Teams with Oncology Research Startup to Eliminate Demographic Disparities in Cancer Treatment
September 13, 2021
Studies show that demographic differences can impact cancer care and that disadvantaged populations suffer from a lack of access to advanced precision cancer diagnostics and treatments. Evaluating and … [Read more...]
FDA Watch
FDA Watch: VALID and VITAL Bills for LDTs Regulation Are Back in Play
August 17, 2021
Reform of FDA Laboratory Developed Tests (LDTs) regulation is back on the agenda and this time it may result in actual legislation. Fired by the agency’s ineffectiveness in bringing new SARS-CoV-2 … [Read more...]
DX Deals
Cloud-Based Platform Enlists Quest to Provide COVID-19 Molecular Test Results to Travelers
August 16, 2021
As proof of COVID-19 vaccination and/or negative molecular test results morphs into a passport for air travel and attending live events, labs with the capacity to generate rapid and reliable tests and … [Read more...]
Labs in Court
Georgia Lab Owner Must Stand Criminal Trial for CGx Kickback and Billing Scam
August 10, 2021
Case: In 2019, the feds indicted the owner of a Georgia lab for allegedly paying kickbacks to patient recruiters to engage in telemarketing campaigns and health fairs in an effort to drum up referrals … [Read more...]
Labs in Court
Florida Telemarketers Indicted for $47 Million Genetic Test Fraud Scheme
August 5, 2021
Case: A federal grand jury indicted three telemarketing company owners for a smorgasbord of fraud, kickback and money laundering violations that allegedly cost Medicare $47 million medically … [Read more...]
DX Deals
Amazon Already Making a Mark on Direct-to-Consumer COVID-19 Test Market
July 11, 2021
Will Amazon transform diagnostic lab testing the way it did the retail industry? Probably not. But the tech giant with the proven capacity to reach into the home and change the shopping patterns of … [Read more...]
Inside the Lab Industry
Even Without COVID-19, Infectious Disease Test Market on Track for Steady Growth
July 1, 2021
From a pure business perspective, the pandemic has been a windfall for Abbott, Cepheid, PerkinElmer, Roche, Thermo Fisher Scientific and other COVID-19 testing companies. However, while the COVID-19 … [Read more...]
FDA Watch
Agency Okays COVID-19 Blood Spot Self-Collection & Molecular Test Pooling
June 14, 2021
Pandemic pressures continue to produce unprecedented action from the FDA. The current imperative is to clear assays and collection kits for rapid and easy screening, including products that can be … [Read more...]
DX Deals
Labs Cutting Deals to Provide Pooled COVID-19 Testing for Schools
June 14, 2021
As schools return to in-person learning environments, communities across the country are turning to COVID-19 testing programs to monitor and contain the virus. Although, more and more teachers, … [Read more...]
