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
January 14, 2020
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
January 14, 2020
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
January 14, 2020
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?
January 13, 2020
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
January 3, 2020
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
January 3, 2020
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
December 31, 2019
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
December 3, 2019
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
December 3, 2019
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...]
