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...]

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...]

MEDICARE REIMBURSEMENT

CMS Finalizes Controversial PAMA Fee Schedule

It's official. CMS is going forward with its controversial 2018 PAMA Clinical Laboratory Fee Schedule (CLFS). Regrettably, the final version closely tracks the preliminary one (See GCA, Oct. 24, 2017, … [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...]

PAMA

CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times

By Kyle Fetter  bio The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA … [Read more...]

REPORT

Outreach Labs Remain Profitable Despite Antiquated Systems & Lack of Exec Respect

Hidden within the basement of your average hospital is a $24 million business, one that provides a top quality, must-have service and operates at a margin of around 25% to 30%. That business is the … [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...]

CAPITAL

Industry Trends: New Report Sheds Light on DX Tech Capital Flows

The health care industry has raised $5 billion in venture fund investment in the first half of 2017 and is well on pace to smash the single year record of $7.5 billion set in 2015, according to … [Read more...]

PAMA

Draft 2018 CLFS Reveals Fundamental Flaws in PAMA Reporting Exercise; Time to Take Action

By Lâle White  bio As XIFIN predicted, the PAMA reporting exercise has resulted in significant proposed laboratory fee cuts. In fact, the multi-year decrease for the top 20 laboratory tests … [Read more...]


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