Genomic testing is inconsistently utilized in the U.S., even in states with favorable coverage policies. Those are the findings of a report from the Personalized Medicine Coalition (PMC) released in … [Read more...]
Precision Medicine
New ACOG Guidelines Recommend cfDNA-Based NIPT for All Pregnancies, Not Just Risky Ones
August 29, 2020
The American College of Obstetricians and Gynecologists (ACOG) has revised its position on noninvasive prenatal testing (NIPT) and is now recommending prenatal aneuploidy screening for all pregnant … [Read more...]
Reimbursement
Payors Gradually Increasing Coverage of Liquid Biopsies but Obstacles Remain
July 28, 2020
Gaining the acceptance of insurers and payors for new tests and testing technology is a perennial challenge for laboratories and test developers. This has been especially true with liquid biopsy … [Read more...]
Genetic Testing
Despite Recommendations, Autism Patients Are Not Fragile X, Karyotype or CMA Testing
May 26, 2020
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 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...]
