INDUSTRY BUZZ

FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway

A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including: FoundationOne's CDx (F1CDx) companion diagnostic test for solid tumors; and Memorial … [Read more...]

INSIDE THE LAB INDUSTRY

PAMA-geddon: Lab Industry Asks Court to Stop New Medicare Fee Schedule

With CMS refusing to back down, the lab industry has escalated the dispute and asked a U.S. District Court to step in and prevent enforcement of the 2018 PAMA-inspired Part B Clinical Lab Fee Schedule … [Read more...]

HEALTH CARE REFORM

Utilization Trends: Teaching Hospitals Consistently Order More Lab Tests

A new study provides solid evidence for a long-held assumption about how hospitals consume lab tests: teaching hospitals utilize tests at a consistently higher rate than nonteaching hospitals. The … [Read more...]

INDUSTRY BUZZ

LDTs: Top 10 New FDA Diagnostic Approvals of 2017

The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo, jealous of its authority and suspicious of the industry it … [Read more...]

DEALS

Industry Buzz: 2017-The Year in DX Mergers & Acquisitions

Meh. That word best describes the state of 2017 merger and acquisition activity in the clinical laboratory space, where firms continue to prefer alliance to absorption at a rate of over 3 to 1. But … [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- November through December. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s) Thermo Fisher Scientific Ion … [Read more...]

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...]

FALSE CLAIMS

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Using Nuclear Stress Tests as Screening Procedure = Medical Necessity Violation Case: A California cardio clinic and its physician owners will pay $1.2 million to settle charges of falsely billing … [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...]


(-0000g2)