PARTNERSHIPS

AACC Collaborates on Adaptive Learning Resource

Laboratory professionals will now have a new tool in the search for knowledge. The American Association for Clinical Chemistry, the NEJM Group, and Area9 Learning are joining forces to provide AACC … [Read more...]

EARNINGS

Diagnostics Sector Reports 4Q Earnings

Fourth quarter earnings reports are starting to trickle in. Here is a big picture roundup of some of the key results so far. Gainers Companies with strong 4Q diagnostics revenues include: Abbott … [Read more...]

INDUSTRY BUZZ

Deal of the Month: $25 Billion Acquisition of St. Jude Med Cements Abbott as Leader in Cardiovascular Device Market

In a month with an unusually heavy volume of diagnostic deal making, the headline story was Abbott Laboratories' $25 billion purchase of fellow device-making giant St. Jude Medical, which finally … [Read more...]

REVENUES

Diagnostics Earnings Report: Abbott, Quest, Genomics Labs Pace Fourth Quarter Growth

Fourth quarter earnings reports are starting to trickle in. Here is a big picture roundup of some of the key results so far. Gainers Companies with strong 4Q diagnostics revenues include: Abbott … [Read more...]

NEWS

FDA Watch: Discussion Paper Signals New Approach (Not Retreat) to LDT Regulation

After nearly two years of inactivity, things are suddenly heating up on FDA regulation of laboratory developed tests (LDTs). As promised, the agency took action on LDTs by the end of 2016—but not in … [Read more...]

PARTNERSHIPS

Diagnostics Companies Form Coalition Supporting cfDNA Prenatal Testing

Five major players in genetic testing have joined forces to promote cell-free DNA (cfDNA)-based noninvasive prenatal testing (NIPT). A newly formed organization, Coalition for Access to Prenatal … [Read more...]

NEWS

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...]

INDUSTRY BUZZ

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

The Arizona Attorney General's Office (AGO) recently issued a request for proposal signaling a new legal battle for Theranos: state consumer fraud lawsuits. The AGO indicated in its request that it … [Read more...]

EMERGING TESTS

FDA Approves Next-Gen Companion Diagnostic

A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test. The FDA … [Read more...]

REIMBURSEMENT

Update on Palmetto’s Molecular Dx Testing LCDs

Advanced diagnostic tests are emerging faster than the clinicians can document their clinical utility. All of this creates an interesting dilemma for payors as far as coverage is concerned. Normally … [Read more...]


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