Beware of Backlash When Restructuring Commission Arrangements for EKRA Sales Commissions & EKRA Liability Risks

The following is an excerpt from the Master Guide to Clinical Lab Compliance 2021 Edition available here. To comply with EKRA, labs have been eliminating traditional commissions and bonuses from … [Read more...]

FDA Watch

Final Rule Clarifies Liability for Off-Label Uses and Lab’s Right to Create LDTs

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...]

DX Deals

Labcorp Teams with Oncology Research Startup to Eliminate Demographic Disparities in Cancer Treatment

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

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

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

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

  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

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

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

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...]