MERGERS

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

Good news for any of you who slept through December 2017: You didn't miss much—at least as far as blockbuster strategic deals in the clinical laboratory space are concerned. M&AIn contrast to … [Read more...]

NEW PRODUCTS

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

Here's a rundown of the key diagnostic product launches from mid-October through November. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s) llumina NextSeq 550Dx NGS … [Read more...]

DISTRIBUTION AGREEMENTS

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

The pattern of high volume and relatively low impact continued with strategic alliances outnumbering acquisitions at rate of roughly 3:1. M&A Following the trio of mega-deal closings, … [Read more...]

INDUSTRY BUZZ

FDA Watch: New Policy Would Allow DTC Marketing of Genetic Tests without Premarket Approval

For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests. On Nov. 6, the agency finally made a move in that direction … [Read more...]

INDUSTRY BUZZ

FDA Watch: New Moves to Boost CLIA Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]

AGREEMENTS

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

Deal volume was high during the month. But most of the deals were small and research-based. M&A It took over 18 months but the Abbott-Alere merger finally closed on Oct. 3. Alere got quite the … [Read more...]

NEW PRODUCTS

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

Here's a rundown of the key diagnostic product launches from late September through mid-October. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s) Episona Consumer launch of … [Read more...]

NEWS

FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”

The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the FDA Office of In Vitro Diagnostics (OIVD), announced that he will step down from … [Read more...]

NEW PRODUCTS

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

Although it did not launch any new products, Quest announced that its existing low density lipoprotein (LDL) cholesterol tests are using a new calculation that not only improves accuracy but also … [Read more...]

ACQUISITIONS

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

Strategic alliance rather than M&A remains the preferred form of strategic interaction in the lab industry. M&A The preference of diagnostic companies to work with rather than digest each … [Read more...]


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