NEWS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

The big story of April wasn't any particular new deal but the apparent resolution of an old one—the Abbott-Alere merger. Deal volume remained brisk, particularly in the alliance arena. But for those … [Read more...]

FDA

23andMe Wins FDA Approval for DTC Genetic Test

23andMe and the U.S. Food and Drug Administration (FDA) announced this month that the agency has allowed marketing of 23andMe's Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases … [Read more...]

REIMBURSEMENT

CMS Enforcement Discretion Eases Pressure on Labs

After we went to press last month, the Centers for Medicare and Medicaid Services (CMS) announced just in the nick of time that it wouldn't impose civil monetary penalties against labs which failed to … [Read more...]

FDA

FDA Exempts 71 Class I Device Types From 510(k) Filings

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

DEALS

Abbott and Alere Reach New Deal Terms

Abbott's deal to acquire Alere is back on. Both companies announced Friday, April 14, 2017, that they will move forward with the deal and have revised its terms. Abbott, a global health care company … [Read more...]

TOP OF THE NEWS

Trump Budget “Blueprint”: 4 Ways It Will Impact Labs

President Trump's 2018 budget proposal includes a number of items likely to affect your laboratory. Here are the four things lab managers need to know about the proposal. What It Is & Is Not The … [Read more...]

IMMIGRATION

Revised Travel Ban Issued

We recently outlined the major effects and the steps you can take to manage the impact of the travel ban executive order (See G2 Compliance Advisor, February 2017). Although that guidance was based on … [Read more...]

INVESTMENTS

Inside the Lab Industry: Silicon Valley Bank Reports Steady 2016 Dx Investments, Declining Exits

Investments in the diagnostics and tools (Dx/Tools) sector remained steady in 2016, according to Silicon Valley Bank's annual report, Trends in Healthcare Investments and Exits 2017. The report's … [Read more...]

NEWS

The 6 Things Labs Need to Know About the Trump Travel Ban

Although the first Trump travel ban didn't survive, a new version is already in the works. Although we don't yet know the details, the expectation is that the new travel ban will look a whole lot like … [Read more...]

NEWS

Industry Newsmaker: Veracyte, Inc. Scores Big with Percepta and Affirma GEC

Veracyte, Inc. is a leader in developing noninvasive genomic diagnostic tests for lung cancer. And in February, Veracyte's share of this lucrative market grew significantly. Percepta Gets Thumbs Up … [Read more...]


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