On Jan 22, Ottawa-based DNA Genotek announced that it has obtained FDA 510(k) clearance for its Oragene Dx kits for collecting saliva samples for DNA testing. According to the company, Oragene Dx is … [Read more...]
PUBLIC HEALTH
The DX Pipeline: OraSure Subsidiary’s DNA Test Sample Collection Kit Gets FDA Greenlight
February 8, 2020
NEW PRODUCTS
FDA Watch: Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
February 8, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
Increasing Profits
Strategic planning needs to evolve over time
February 6, 2020
By Nick Hernandez bio Some of my counterparts have a firm belief that strategic planning is a rigid process which should occur once every three to five years. The process they undertake is often … [Read more...]
DIAGNOSTIC DEALS
Diagnostic Deals: Lab Corp & Quest to Continue Targeting Small and Independent Labs for Acquisition
January 31, 2020
PAMA price cuts were supposed to drive consolidation in the lab market. The expectation was that price pressures would make it impossible for smaller labs to remain independent, rendering them juicy … [Read more...]
FDA Watch
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
January 30, 2020
There are no FDA-cleared tests to detect the new 2019-nCoV Wuhan coronavirus. But on Jan. 28, the agency unveiled its strategy to promote the rapid development and availability of safe and effective … [Read more...]
Industry Buzz
Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
January 30, 2020
Along with an urgent public health challenge, the outbreak of the novel 2019-nCoV coronavirus in Wuhan, China, first reported on Dec. 31, has created a strategic opportunity for makers of lab tests. … [Read more...]
Lab Safety
Doing What We’ve Always Done
January 27, 2020
By Dan Scungio bio Scenario: The reference cytology lab has always had limited storage space for supplies and specimens. They use tall wire racks to store the many liquid-based cytology specimen … [Read more...]
Current Issue of LIR
January 24, 2020
Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download LIR content: I agree that I am the the only person who is accessing my … [Read more...]
Billing & Collections
Finding the “Backdoor” into Payer Networks
January 20, 2020
By Steve Selbst bio I am delighted to be able to share with you a key “secret to success” about payer contracting. Today’s article is about getting in the “backdoor” with payers and complementing … [Read more...]
Employment Law Update
New overtime rule now in effect
January 14, 2020
By Mike O’Brien bio Jan. 1, 2020 was the deadline to comply with new FLSA overtime rule. At the end of September the Department of Labor issued its long-awaited final rule updating the salary … [Read more...]
