CLN - Regulatory Roundup

FDA OKs 23andMe to Report Pharmacogenomic Variants Without Confirmatory Testing

Regulatory Roundup: JulyAug 2021

The Food and Drug Administration (FDA) has granted 23andMe 510(k) clearance for a pharmacogenomics report for two medications: clopidogrel, which is prescribed for certain heart conditions, and citalopram, which is prescribed for depression.

This 510(k) clearance modifies the labeling of the previously authorized 23andMe CYP2C19 Drug Metabolism Report, removing the need for confirmatory testing and allowing the company to provide interpretive drug information based on genetic factors for these specific medications.

Individuals with certain genetic variants that affect how the CYP2C19 enzyme metabolizes drugs may experience reduced efficacy with clopidogrel and citalopram. They may also have increased chances of side effects—some of which could lead to life-threatening adverse events, such as cardiac problems. With this new pharmacogenomics report, consumers can learn if they have variants of the CYP2C19 gene or any other clinically validated pharmacogenomic associations consistent with the FDA-approved drug labels for these medications. Consumers can then share this information with their doctors to determine if any modifications to their medication regimes are needed.

In order to meet FDA requirements for this new clearance, 23andMe performed method comparison studies designed to increase the likelihood of obtaining rare *3 allele combinations and further mitigate the risk of false-positive and false-negative results. Through this, the company found that the accuracy of its pharmacogenetics report exceeds 99% concordance with Sanger sequencing.

CE Mark Granted to BD HPV Assay for Use With At-Home Self-Collected Samples

BD has earned the CE mark for a new at-home self-collection indication for the BD Onclarity HPV assay. This new indication enables patients to self-collect samples for human papillomavirus (HPV) screening using a BD diluent tube. Patients send their samples to a laboratory, where they’re processed using the Onclarity HPV assay on either the BD Viper LT, which is in use globally, or the BD COR system, which is in use across Europe. In a single analysis, the BD Onclarity HPV assay detects and provides genotyping information for the following 14 HPV types: 16, 18, 31, 45, 51, 52, 33/58, 35/39/68, and 56/59/66.

Studies have shown that adding at-home collection as an option to cervical cancer screening programs increases participation. BD therefore hopes that the new indication for the Onclarity HPV assay will help address the public health challenge of reaching women who do not attend routine cervical cancer screening—a problem that has recently been compounded by the COVID-19 pandemic.

FDA authorizes NowDiagnostics’ Rapid, Point-of-Care SARS-CoV-2 Antibody Test

NowDiagnostics has received emergency use authorization (EUA) from the Food and Drug Administration for its point-of-care AdexusDx COVID-19 antibody test. Following this EUA, NowDiagnostics will offer this test across a variety of CLIA-waived healthcare settings, such as pharmacies, clinics, and hospital emergency rooms. The company is also conducting studies in order to make the technology behind the AdexusDx available for over-the-counter detection of SARS-CoV-2 antibodies. The test analyzes 40 µL of either fingerstick or venous whole blood, serum, or plasma. Using separation microfluidics and proprietary multilayer membranes, it separates plasma from whole blood automatically and displays results in 15 minutes. Performance of the AdexusDx does not require a phlebotomist, buffers, reagents, or additional equipment, making it suitable for large-scale testing as well as testing in remote or under-resourced areas.

NowDiagnostics developed this test with funding and technical support from the Biomedical Advanced Research and Development Authority, which is part of the U.S. Department of Health and Human Services.

FDA Gives Nod to Phosphorus Diagnostics for At-Home SARS-CoV-2 Saliva Test

Phosphorus Diagnostics has received Food and Drug Administration emergency use authorization for its SARS-CoV-2 saliva test featuring at-home sample collection. The test was developed at Phosphorus’ CLIA laboratory in Secaucus, New Jersey and uses OraSure’s OrageneDx (OGD-510) saliva collection device. Consumers can order the test online, and Phosphorus is also making the test available through partnerships between employers and healthcare providers with the goal of helping companies safely resume operations. After ordering the test, consumers will be directed to complete a medical questionnaire that will then be reviewed by an independent physician. Once the physician approves the order, Phosphorus will ship a sample collection kit to the consumer’s home. The consumer can then collect a saliva sample without supervision and ship it back to the lab. Test results will be available within 72 hours after the laboratory receives the sample and will be accompanied by a consultation from medical personnel.

FoundationOne CDx Gets FDA Approval for Use as Bile Duct Cancer Co-Diagnostic

The Food and Drug Administration (FDA) has approved Foundation Medicine’s FoundationOne CDx test for use as a companion diagnostic with the new bile duct cancer therapeutic infigratinib. Infigratinib, which is marketed as Truseltiq by QED Therapeutics, is a kinase inhibitor for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. Using formalin-fixed paraffin-embedded tissue specimens, FoundationOne CDx analyzes numerous guideline-recommended genes in solid tumors, including FGFR2, and can therefore identify patients who are most likely to benefit from infigratinib. The test has previously received FDA approval for use as a companion diagnostic with more than 20 other targeted therapies, including drugs for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, ovarian cancer, and prostate cancer. In addition to gene analysis, the test’s results include microsatellite instability and tumor mutational burden to help inform immunotherapy decisions, and loss of heterozygosity for ovarian cancer patients.