As coronavirus continues to spread and claim more lives, the development of a quick, safe and effective diagnostic test for detecting the 2019-nCoV virus has become an urgent global priority. Not … [Read more...]
Coronavirus
Emerging Tests: Progress & Key Developments in the Scramble to Develop a Rapid Coronavirus Detection Test
March 4, 2020
FDA Watch: Agency Grants Emergency Clearance for CDC Novel Coronavirus Detection Test
March 2, 2020
Because the 2019 novel coronavirus outbreak was so unanticipated, there were no FDA-approved commercial products for it available in the US during its early days. On Jan. 28, the FDA unveiled its … [Read more...]
Emerging Tests: Lab Industry Mobilizes to Develop Coronavirus Detection Test
March 2, 2020
The global coronavirus (COVID-19) outbreak came without warning and is having a seismic impact on laboratories and the diagnostics business. The imperative for the industry right now is to develop a … [Read more...]
PUBLIC HEALTH
The DX Pipeline: OraSure Subsidiary’s DNA Test Sample Collection Kit Gets FDA Greenlight
February 8, 2020
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...]
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...]
GENETIC TESTING
Test Quality: New Study Casts Doubt on Whole Exome Sequencing’s Accuracy in Diagnosing Genetic Disorders
January 24, 2020
Depending on the reporting laboratory, patients who undergo whole exome sequencing may receive false negatives or incomplete test results. That is the finding of a new study published in Clinical … [Read more...]
REIMBURSEMENT
Genetic Testing: New Medicare Early NGS Cancer Test Coverage Policy Is Less than Meets the Eye
January 3, 2020
For Myriad Genetics, Foundation Medicine and other manufacturers of next-generation sequencing (NGS)-based test panels for early-stage cancer risk assessment, the recent announcement of CMS’ decision … [Read more...]
Emerging Tests: New Study Supports Feasibility of At-Home Urine Prostate Cancer Testing
January 2, 2020
One of the most challenging aspects of prostate cancer diagnosis is collecting urine samples from patients. In addition to being highly uncomfortable, post-digital rectal examination collection yields … [Read more...]
EMERGING TESTS
FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials
November 19, 2019
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, 2019, the US Food and Drug … [Read more...]
