As usual, the Big 3 of Abbott, Quest and LabCorp were the driving force of M&A activity in the diagnostics industry in the first half of 2017. Abbott Continues to Make News Each company … [Read more...]
ORDERING PHYSICIANS
Ordering Physicians: Oncologists Say Genomic Testing Is Overhyped
August 7, 2017
When it comes to measuring Dx product effectiveness, few things speak louder than the attitudes of ordering physicians. With that in mind, genomic test manufacturers might want to take pause from a … [Read more...]
NEWS
Focus On: Quest-Walmart Deal Latest in Mass Retailing of Lab Tests
July 25, 2017
Laboratory test products have been appearing on the shelves of mass retail stores with growing frequency. But the newly announced partnership between Walmart and Quest Diagnostics raises eyebrows … [Read more...]
MOLECULAR TESTS
Palmetto Gives Okay to Medicare Coverage of 5 New Molecular Tests
July 17, 2017
Medicare contractors are slowly coming around on covering unproven molecular assays. The most notable new baby steps come from, Palmetto GBA (Columbia, SC), one of Medicare's most important … [Read more...]
DOJ
Medical Necessity Requirement Bites Anatomic Pathologists
June 6, 2017
By Robert Mazer bio The DOJ has announced two separate settlements involving claims for allegedly unnecessary special stains. Medicare permits a pathologist to order special stains when … [Read more...]
MANAGING THE LAB
5 ways to end generational stereotyping in your lab
May 22, 2017
By Dr. William A. Schiemann bio These days, the Millennial Generation is hyped, perhaps even more than Baby Boomers were hyped in the 1950s and 1960s. As I meet with executives around the … [Read more...]
EMERGING MARKETS
Blood-Based Concussion Diagnostic Tests
April 25, 2017
There is a great need for better tools to diagnose concussion. Currently, there is no single marker of panel of markers in widespread clinical use and diagnosis remains based on clinical judgment. But … [Read more...]
ENFORCEMENT
Liability Traps to Avoid:
Commission-Based Lab Marketing Arrangements
April 25, 2017
Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on the volume or value … [Read more...]
EMERGING MARKETS
Key Players in Blood-Based Concussion Testing Market
April 24, 2017
There is a great need for better tools to diagnose concussion. Currently, there is no single marker or panel of markers in widespread clinical use and diagnosis remains based on clinical judgment. But … [Read more...]
MARKET TRENDS
FDA EUAs for Zika Tests
(As of March 15, 2017)
March 31, 2017
Date Issued Test Company Feb. 26, 2016* CDC Zika Immunoglobulin M (IgM) Antibody Capture Enzyme-Linked Immunosorbent Assay Zika MAC-ELISA March 17, 2016* CDC Trioplex Real-time RT-PCR … [Read more...]
