FDA WATCH

FDA Watch: Congress Kills Trump Plan to ‘Recalibrate’ User Fees

Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by $103 million, $4.665 billion in total. That includes $2.759 billion for … [Read more...]

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...]

NEW PRODUCTS

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

As usual, genome and sequencing products dominated the diagnostics pipeline last month. Exceptions included rapid diagnostic testing products from Alere, oncology lung testing kits from IncellDx, … [Read more...]

EMERGING MARKETS

Blood-Based Concussion Diagnostic Tests

There is a great need for better tools to diagnose concussion. Currently, there is no single marker of panel of markers in widespread clinical use and diagnosis remains based on clinical judgment. But … [Read more...]

EMERGING MARKETS

Key Players in Blood-Based Concussion Testing Market

There is a great need for better tools to diagnose concussion. Currently, there is no single marker or panel of markers in widespread clinical use and diagnosis remains based on clinical judgment. But … [Read more...]

NEW PRODUCTS

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...]

NEWS

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...]

NEWS

FDA Watch: Doubling of User Fees, LDT Maneuvering & Potential OK for First Diabetes POC Dx Test

Trump Proposes Doubling FDA User Fees The Trump 2018 budget proposal would double user fees that pharma and medical device companies pay the FDA to review their products from $1 to $2 billion. … [Read more...]

MARKET TRENDS

FDA EUAs for Zika Tests
(As of March 15, 2017)

Date Issued Test Company Feb. 26, 2016* CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay Zika MAC-ELISA March 17, 2016* CDC Trioplex Real-time RT-PCR … [Read more...]

MARKET TRENDS

Emerging Markets: The Rapid Rise of Commercial Zika Diagnostics

The rapid emergence of the Zika threat is creating a new in vitro diagnostics market that did not exist a year ago. Here's a quick overview of the Zika market, how it developed and where it stands … [Read more...]


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