The Theranos debacle hasn't dissuaded retailers from partnering with labs. Here's a rundown of some recent deals. LabCorp & Walgreens In fact, Walgreens, Theranos's ex-retail partner, has moved … [Read more...]
DATA
6 Steps to Data-Driven Transformation
November 26, 2018
By Nir Kaldero bio We're now well into the Fourth Industrial Revolution. The First Industrial Revolution was about steam and railroads, the Second about electricity, and the Third brought … [Read more...]
FOCUS ON
Industry Buzz: ACA Constitutionality Is Back in Play
October 11, 2018
After a series of court setbacks, Republicans challenging the constitutionality of Obamacare, aka, the Affordable Care Act (ACA) are back at it. And this time they may win. Beating a Dead Horse? The … [Read more...]
SPECIAL FOCUS
Cost Avoidance vs Cost Savings: What’s the Difference?
August 31, 2018
By Jennifer Dawson, MHA, DLM (ASCP) bio As I work to spread awareness within the clinical laboratory community about the Cost of Poor Quality (COPQ) concept and its benefits as a method to … [Read more...]
FOCUS ON
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
August 6, 2018
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four key takeaways for IVD test makers and labs: 1. No Mandatory … [Read more...]
LITIGATION
Are Genetic Testing Labs Liable for Medical Malpractice?
July 30, 2018
Consumer-based genetic testing has become a $3 billion business with a seemingly limitless future. But the industry is also facing a legal threat to future growth: malpractice liability. In the past … [Read more...]
FOCUS ON
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
June 19, 2018
In a notice for public comment issued last November, the FDA raised eyebrows by floating a proposal that would make it easier to bring new genetic health risk (GHR) assessment tests to market. The … [Read more...]
FOCUS ON
Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
June 19, 2018
Earlier this month, the FDA finalized new rules designed to relax the regulatory obstacles faced by manufacturers in commercializing new genetic health risk assessment tests. And now an earlier … [Read more...]
FOCUS ON
New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
May 14, 2018
Test makers have long complained about the FDA's unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address those concerns by issuing a pair of … [Read more...]
FOCUS ON
Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
April 30, 2018
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements: Sharply lower prices for traditional tests; and Wider coverage of newly emerging tests, including some that … [Read more...]
