Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval

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...]


FDA Watch: Expanded Label Clearance Opens Cologuard to a Younger Market

September was an eventful month for one of the hottest products on the consumer genetic test market, the Cologuard multi-target stool DNA test (mtSDNA) for colorectal cancer screening produced by … [Read more...]

Testing Trends: AMP Creates New Quality Guidelines for PGx Laboratory Testing

Pharmacogenetic (PGx) testing has recently come under fire from both the scientific and regulatory community for its lack of self-policing. But the new Association for Molecular Pathology (AMP) … [Read more...]

Test Utilization: New Guidelines Recommend Basing Routine Colorectal Cancer Screening on Risk Rather than Age

Even people who are not in diagnostics have probably heard that adults age 50 to 79 should get routine colorectal screening exams. But now that longstanding recommendation has changed. According to … [Read more...]

Innovation: Breathalyzer May Offer Reliable, Easier Alternative to Blood-Based Opioid Detection

Police officers, law enforcers, employers and drug testing laboratories may soon have a new tool: a breathalyzer test capable of detecting opioid drugs. Engineers and physicians from the University of … [Read more...]

Inside the Diagnostics Industry: Quest-hc 1 System Leverages Lab Data to Help Providers Monitor Test Utilization

Getting Medicare and private insurers to pay for lab tests is as challenging as it’s ever been. It’s not just about reimbursement. Payors have become fanatically dedicated to weeding out lab testing … [Read more...]

New Study Suggests Blood Testing May Be Capable of Diagnosing PTSD

As post-traumatic stress disorder (PTSD) becomes more widespread, it may be becoming easier to diagnose. A new study suggests that it may soon be possible to detect PTSD by using a quick blood test … [Read more...]

Current Issue of DTET

  Before You Download Please read the following user agreement and confirm your acceptance of the terms before you download DTET content: I agree that I am the the only person who is … [Read more...]


Laboratory Information Systems (LIS): What You Need To Know To Get Paid

By Sean McSweeney  bio Today, laboratory billing claims require more and more data to successfully get paid. One of the biggest reasons your claims may be getting denied is because you're not … [Read more...]


Inside the Diagnostics Industry: New Government BRCA Test Guidelines Are a Mixed Bag for Genetic Testing Labs

The US Preventive Services Task Force (USPSTF) issued updated recommendations for BRCA-related cancer risk assessment, genetic counseling and testing in the Aug. 20 issue of the Journal of the … [Read more...]