DIAGNOSTIC DEALS

Diagnostic Deals: Illumina/PacBio Merger Derails & Qiagen Takes Itself Out of Play

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

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

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...]

DIAGNOSTIC DEALS

Diagnostic Deals: The Fate of Illumina-PacBio Merger Hangs in the Balance

Will they or won’t they? The suspense continues over whether Illumina’s proposed rescue of Pacific Biosciences will actually close. The $1.2 billion cash merger, which was originally expected to close … [Read more...]

Global News: EU Delays Launch of Eudamed Database

The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022.  Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: A roundup of the key mergers, acquisitions, alliances, licenses and other strategic transactions from the past month

Although briskness in alliances partially offset sluggishness in M&A, October was far less dynamic than September for strategic deal making within the diagnostics sector. Here’s an overview of the … [Read more...]

NEW PRODUCTS

FDA Watch: New Process for Simultaneous Review IVD Tests Used in Cancer Drug Trials

Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final … [Read more...]

NEW PRODUCTS

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

With 10 days still left to run, October was shaping up to be the busiest month of 2019 for new product launches. Here’s a summary of the key diagnostic products unveiled so far: NEWLY … [Read more...]

NEW PRODUCTS

The DX Pipeline: A Roundup of the Month’s Key New Product Launches

Here's a summary of the key product launches announced from late August through the third week of September, 2019: NEWLY LAUNCHED PRODUCTS & … [Read more...]

FDA WATCH

FDA Watch: New NGS Data Guidance May Ease Antiviral Drugs & Companion Test Approvals

A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic … [Read more...]


(-00000g2)