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
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...]
EMERGING TESTS
Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval
October 17, 2019
Next generation sequencing (NGS) data supporting resistance assessments is crucial to developing and gaining FDA clearance for new antiviral drugs and related companion diagnostic tests (CDx). Now the … [Read more...]
INDUSTRY BUZZ
Industry Buzz: Cologuard’s Wild September Ride
October 16, 2019
The month of September was a rollercoaster for a product that has in many ways become the face of the consumer genetic testing market, Exact Sciences’ Cologuard. The Growth of Cologuard The … [Read more...]
FDA WATCH
Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays
September 24, 2019
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against Borrelia burgdorferi, the bacteria that causes the disease, in a patient's blood. Traditional testing uses … [Read more...]
