On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic (IVD) in an oncology clinical trial is … [Read more...]
NEW PRODUCT DEVELOPMENT
New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
November 15, 2019
Global News: EU Delays Launch of Eudamed Database
November 14, 2019
The European Commission (EC) is delaying the launch of the European database on Medical devices (aka Eudamed) until May 2022. Originally, manufacturers were supposed to be compliant by May 2020 with … [Read more...]
Industry News
Kellison and G2 Intelligence Honor Dr. Sidney Goldblatt
November 13, 2019
Dr. Sidney Goldblatt, MD, is the 2019 recipient of the Kellison Public Service Award. Dr. Goldblatt has been founder, medical director and CEO of Molecular Dx; founder and CEO of Goldblatt Systems; … [Read more...]
INNOVATION
Point of Care: Handheld Device Shows Promise in Detecting Concussion from Blood Samples
September 24, 2019
A handheld portable device could be more effective than a CT scan in detecting mild traumatic brain injuries (TBI), according to a new study published in The Lancet Neurology. Because it is capable of … [Read more...]
SAFETY
Business Trends: Commercial Testing Companies ‘Sell’ Health Screenings
August 12, 2019
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
Google This: Labs Partner with Tech Giant
July 28, 2019
In recent months, several diagnostic companies have announced alliances with Google, and all involve Google Cloud Platform. Here is how four companies are using Google's … [Read more...]
FOCUS ON
Surviving PAMA: Keep an Eye on Industry Disruptors
July 16, 2019
A talking point of a G2 Lab Institute 2018 presentation deserves closer attention, especially given its implications for the lab industry. "Advantages and Disadvantages Confronting Labs in a … [Read more...]
INNOVATION
Multi-Cancer Screening Tests Are Getting Closer to Reality
July 15, 2019
The hope of developing a single blood test capable of detecting multiple types of early-stage cancer is getting closer to becoming a reality. Two hopeful players, GRAIL (Menlo Park, Calif.) and Thrive … [Read more...]
INNOVATION
Rapid, Genomic-Based Surveillance IDs Aids Hospital Infection Control
May 23, 2019
Routine genomic sequencing can identify and inform hospital infection control personnel of patient transmission events in near real-time, enhancing not only detection, but follow-up and investigation … [Read more...]
NEWS
DNA Testing at the Border
May 21, 2019
The Department of Homeland Security (DHS) is piloting a DNA testing program at the U.S.-Mexico border. The program aims to establish "DNA-based family relationship (kinship) verification to improve … [Read more...]
