Several companies market an array of preventive tests directly to consumers. Are these companies and tests legit? What does the medical community have to say about such companies and advertising … [Read more...]
INDUSTRY BUZZ
FDA Watch: First Zika Assay Gets Green Light for Marketing
July 22, 2019
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for Zika. But on May 23, 2019, the FDA did something it had never done before: It … [Read more...]
TECHNOLOGY
Top 4 trends shaping the healthcare industry
July 8, 2019
By Leora Borgenicht bio Before the healthcare industry can ambitiously transform to offer more accurate and personalized patient care, certain stepping stones must be reached. These four … [Read more...]
INDUSTRY BUZZ
FDA Watch: Agency Approves New STD Screening Assay Applications
July 1, 2019
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the throat and rectum. The tests, … [Read more...]
FOCUS ON
Business Best Practices: The 5 Essential Components of a Marketing Plan
June 10, 2019
Although there's no single formula for marketing a lab, there are five basic elements a marketing plan should include. 1. A Website An online presence is a must for even single-location labs. The … [Read more...]
HUMAN RESOURCES
Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees
May 6, 2019
A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost. New research from WorkJam, a digital workplace platform, found that for nearly half of employees … [Read more...]
INDUSTRY BUZZ
FDA Watch: New Warning Letter May Signal Resurgence of LDT Enforcement Activity
April 29, 2019
After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on April 4, when the agency issued a warning letter to Inova Genomics Laboratory (Inova) for … [Read more...]
INDUSTRY BUZZ
Improved Accuracy of Point-of-Care HbA1c Tests May Expand Access to Testing
April 26, 2019
Good news for Abbott and its newly acquired Alere Technologies: A new study published in the Journal of Diabetes Science and Technology finds that the latter's POC Afinion HbA1c Dx test is accurate … [Read more...]
COMPLIANCE
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
April 15, 2019
By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests … [Read more...]
INDUSTRY BUZZ
FDA Watch: Gottlieb Resignation Costs Lab Industry a Valuable Frenemy
March 27, 2019
Scott Gottlieb, M.D., is resigning as FDA commissioner, the position he's held since 2017. Although his reign lasted just two years, Gottlieb has been a longtime friend and foe of the lab industry … [Read more...]
