Employment Law Update

New overtime rule now in effect

By Mike O’Brien bio Jan. 1, 2020 was the deadline to comply with new FLSA overtime rule. At the end of September the Department of Labor issued its long-awaited final rule updating the salary … [Read more...]

NEW PRODUCTS

The DX Pipeline: New Invitae App Leverages Apple Watch Data for Studying Disease Genetics

Invitae’s newly launched Invitae Discover app is in many ways the perfect manifestation of where consumer-based precision medicine diagnostics is heading. The app combines health and activity data … [Read more...]

NEW PRODUCTS

FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]

DEALS

Industry Buzz: The 10 Biggest DX Mergers of 2019

Conspicuous by its absence from the list is the proposed $1.2 billion Illumina takeover of Pacific Biosciences which suddenly seems to be in major trouble. Here are the 10-highest value M&A … [Read more...]

BILLING & COLLECTIONS

Accessions Disappearing or Not Getting Billed?

By Sean McSweeney bio Ever get that feeling that there should be more charges in the billing system? How many times have you or someone else said something like “we did 3000 samples last month, but … [Read more...]

REIMBURSEMENT

Genetic Testing: New Medicare Early NGS Cancer Test Coverage Policy Is Less than Meets the Eye

For Myriad Genetics, Foundation Medicine and other manufacturers of next-generation sequencing (NGS)-based test panels for early-stage cancer risk assessment, the recent announcement of CMS’ decision … [Read more...]

BILLING & COLLECTIONS

5 ways to break down bureaucracies to get payer contracts

By Steve Selbst bio It is important to remember that payers are large companies, with protocols, policies and business practices. As with any large company, there are bureaucracies, and they are … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: Illumina/PacBio Merger Derails & Qiagen Takes Itself Out of Play

As 2019 came to a close, the biggest story in DX deal making was the pair of anticipated M&A deals that suddenly seem unlikely to happen. As a result, two major genetic testing companies will … [Read more...]

NEW PRODUCTS

The DX Pipeline: A roundup of the month’s key new product launches

The last quarter is typically the busiest of the year for new product launches and 2019 is no exception. The DX pipeline was churning at a high pace from late October to mid-November. Here’s a rundown … [Read more...]

FDA Watch: Agency Clears the Way for Approval of Blood-Based PSA Test

The U.S. Preventive Services Task Force (USPTF) recommends that men age 55 to 65 consider prostate cancer screening. The reason it doesn’t directly recommend testing for all men in this age group is … [Read more...]


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