Confirmatory Testing No Longer Needed for 23andMe’s CYP2C19 Report
The 510(k) clearance allows for modification of the labeling of the previously authorized pharmacogenetics report.
Diagnostic Testing
FDA: COVID-19 Test Could Give Inaccurate Results
Agency issues alert about Thermo Fisher’s TaqPath genetic test.
Guidance Issued for Genetic Testing in Prostate Cancer
Germline testing advised for metastatic disease, family history suggestive of hereditary disease
EyeArt Autonomous AI System Cleared for Diabetic Retinopathy Screening
EyeArt is the first FDA-cleared AI technology for autonomous detection of more than mild diabetic retinopathy and vision-threatening diabetic retinopathy.
Seven States Join Pact to Speed COVID-19 Testing
Bipartisan plan illustrates just how bad testing delays are across the country
USPSTF Still Advises Against Carotid Artery Stenosis Screening
Harms of screening for asymptomatic carotid artery stenosis outweigh benefits in general population.
Respiratory Sampling Strategies for Detecting SARS-CoV-2 Compared
Sputum sampling was found to be a valuable method for diagnosing and monitoring patients with coronavirus disease 2019 (COVID-19), according to a recent systematic review and meta-analysis published in EBioMedicine.
Pooled Sampling Approved for COVID-19 Test
Sample pooling allows for more people to be tested quickly using fewer testing resources.
Symptom-Based Testing Not Adequate for Detecting COVID-19
Universal testing increased the total number of detected COVID-19 cases from 153 to 507 across all sites.
Pap/HPV Cotesting Better for Cervical Cancer Screening in Over 30s
Nondetection rate is 13.1% for cotesting, higher when testing is done >12 months prediagnosis.
