Test Kits Included in Class 1 Devices Exempt from 510k Filing

The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks … [Read more...]


Avoid Liability for Commission-Based Marketing Arrangements

Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on the volume or value … [Read more...]


Key Coverage Determinations and Product Developments

Although several companies secured favorable diagnostic coverage determinations in March, the big winner was Vermillion, manufacturer of the OVA1 ovarian cancer early detection test—the test covered … [Read more...]


Diagnostic Deals: A Roundup of Mergers, Acquisitions, Alliances, Licenses and Other Major Transactions

Two-thirds of the way through the month, March has seen a relatively high volume of strategic deals but mostly of the marginal variety, particularly with regard to M&A activity. M&A The … [Read more...]


Hologic Sells Blood Screening Business

During a slow month for diagnostic M&A activity, a noteworthy deal was Grifols's acquisition of Hologic's blood screening business. The acquired assets include a San Diego plant, development … [Read more...]


Managing Kickback Risks in Lab Sales & Marketing Arrangements

As with any other business, labs need sales and marketing expertise to survive and grow in the competitive diagnostics market. But to the extent you serve patients in Medicare, Medicaid and other … [Read more...]


Diagnostic Deals: A Roundup of February’s Mergers, Acquisitions, Alliances, Licenses and Other Major Transactions

After January's flurry of deals, the M&A front has been relatively quiet so far this month. But relatively low volume of M&A deals has been more than offset by surges in strategic alliances … [Read more...]


Arizona Fraud Suit Opens New Front in the Legal War against Theranos

Suing Theranos has become something of a cottage industry. And now a whole new front in the legal war appears ready to open: state consumer fraud lawsuits. The Arizona Attorney General's Office (AGO) … [Read more...]


Is Offering Free Labelling Services to Dialysis Facilities a Kickback?

SITUATION XYZ Labs wants to offer dialysis facilities free labeling of test tubes and specimen collection containers. But rather than offering it to all dialysis facilities, XYZ Labs would provide … [Read more...]


Diagnostic Deals: A Roundup of January’s Mergers, Acquisitions, Alliances, Licenses and Other Major Transactions

January 2017 has already seen an unusually high volume of diagnostic deal making. Here is a quick overview of the key deals and what they portend. M&A While Abbott Laboratories made the … [Read more...]