Whether due to lack of insurance coverage, personal preference or other reasons, patients with autism spectrum disorder (ASD) are not getting recommended genetic testing. That is the conclusion of a … [Read more...]
Genetic Testing
Despite Recommendations, Autism Patients Are Not Fragile X, Karyotype or CMA Testing
May 26, 2020
Genetic Tests
New NCCN Recommends Biomarker Prostate Cancer Testing for Intermediate- & High-Risk Men
March 23, 2020
With all the COVID-19 hullabaloo, a potentially significant development in genetic prostate cancer testing has flown under the radar. It happened on March 16, when the National Comprehensive Cancer … [Read more...]
FDA Watch
FDA Finalizes CLIA Waiver Guidance for Approval of New In Vitro Diagnostic Devices
March 23, 2020
On Feb. 25, the FDA issued a pair of final guidances to help manufacturers seeking clearance for new in vitro diagnostic devices. Here is a summary of the key points from each guidance. CLIA … [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...]
GENETIC TESTING
FDA Watch: Agency Exempts Dozens of Tests from 510(k) Review
January 24, 2020
On Dec. 30, 2019, the U.S. Food and Drug Administration (FDA) published a final order exempting dozens of Class I and Class II medical devices that previously required 510(k) submission from 510(k) … [Read more...]
EMERGING TESTS
Standard Pathology Tests Outperform Molecular Subtyping in Bladder Cancer Tumor Classification
January 19, 2020
The deadliness of muscle invasive bladder cancer has made the development of new diagnostic and treatment methods imperative. One strategy involves the use of molecular genetic testing to subtype … [Read more...]
ACMG the Latest to Come Out Against Genetic Testing for All Breast Cancer Patients
January 19, 2020
The debate over the need for genetic testing of all breast cancer patients for germline pathogenic or likely pathogenic variants in BRCA1, BRCA2 and other breast cancer-linked genes continues with the … [Read more...]
GENETIC TESTING
FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval
January 3, 2020
Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA’s enforcement priority list this year. The agency has issued seven warning letters related to … [Read more...]
Genetic Testing
Precision Medicine: Are Primary Care Providers Prepared to Interpret Genetic Testing Results?
January 2, 2020
Specialists might be the best choice to interpret genetic testing results, but primary care providers may be positioned to do so when specialists are not available, a new study has found. And that is … [Read more...]
Genetic Tests: NCCN Updates Genetic Breast, Ovarian & Pancreatic Testing Guidelines
January 2, 2020
On Dec. 4, the National Comprehensive Cancer Network (NCCN) issued updated guidelines for use of genetic testing to assess the risk of breast, ovarian and pancreatic cancer. The headliners of the new … [Read more...]
