INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

NEW PRODUCTS

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

Most of the new product launches in late November through December were in the molecular and genomics space. For the second month in a row, Qiagen was among the most active companies with a trio of … [Read more...]

NEW PRODUCTS

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

Here are some of the more notable launches from the busy October-November period. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s)/Service(s) Quest QuestDirect, … [Read more...]

INDUSTRY BUZZ

FDA Watch: First NGS Residual Cancer Detection Test Wins Approval

The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]

DISTRIBUTION AGREEMENTS

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

As the year winds down, diagnostic deals aren't as plentiful. Nevertheless, there have been some significant transactions. Here's a recap of the key activity from mid-October through the third week of … [Read more...]

INDUSTRY BUZZ

FDA Watch: Changes to CBER Email Policy May Affect Your Lab

Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use. The agency changed its email communications policy on … [Read more...]

PARTNERSHIPS

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

The swirl of autumn leaves has brought a swirl of diagnostic deals. Here's a recap of the key activity from mid-September through the third week of October. M&A and Asset Sales Quest Diagnostics … [Read more...]

CUSTOMER SERVICE

Lab Leaders Have New Opportunities in the Age of Consumerism

The G2 Power Panel provided attendees at the 36th annual Lab Institute (Oct. 24-26; Washington, D.C.) an opportunity to learn how some of the nation's leading laboratories are navigating the current … [Read more...]

NEW PRODUCTS

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

The awakening from a sleepy summer that began in September picked up in intensity in October. Here's a rundown of the key new launches during the period. NEWLY LAUNCHED PRODUCTS & … [Read more...]

ACQUISITIONS

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

Amid back to school season, companies were back to making diagnostic deals. Here's a recap of the key activity from mid-August through the third week of September.  M&A and Asset Sales This … [Read more...]


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