The Food and Drug Administration (FDA) has issued an emergency use authorization for Abbott’s BinaxNow COVID-19 Ag Card, the first antigen test that displays results on a testing card similar to an over-the-counter pregnancy test. To perform this test, a healthcare provider first swabs a patient’s nose and mixes the collected sample with a reagent on the test card. After 15 minutes, the result appears on the card, with one line indicating a negative result and two lines indicating a positive result. The BinaxNow COVID-19 Ag Card is authorized for use within 7 days of symptom onset in patients whose healthcare providers suspect they have COVID-19. In FDA’s announcement of its authorization for this test, the agency also notes that, in general, antigen tests have high specificity, but are not as sensitive as molecular tests. Due to this potential for decreased sensitivity, providers and labs might need to confirm negative results from Abbott’s test with a molecular test prior to making treatment decisions.

FDA Approves Guardant Health’s NGS-Based Liquid Biopsy Companion Diagnostic

Guardant Health has received Food and Drug Administration (FDA) approval for the Guardant360 CDx assay, making this the first FDA-approved liquid biopsy companion diagnostic that uses next-generation sequencing technology. Intended for use in non-small cell lung cancer (NSCLC) patients, the test simultaneously detects mutations in 55 tumor genes, with a particular focus on mutations of the epidermal growth factor receptor gene that indicate whether a patient might benefit from treatment with Tagrisso (osimertinib). Tagrisso is an FDA-approved therapy developed by AstraZeneca for metastatic NSCLC. The Guardant360 CDx is also approved to provide information on multiple other solid tumor biomarkers, but genomic findings for these other biomarkers are not currently validated for choosing a particular corresponding treatment. Additionally, labs should be aware that if the Guardant360 Dx does not detect the specific NSCLC mutations associated with this FDA approval, then a follow-up tumor biopsy should be performed to confirm whether or not these mutations are present.

FDA Gives EUA to Siemens for Semi-Quantitative Antibody Test

Siemens Healthineers has received emergency use authorization from the Food and Drug Administration (FDA) for its SARS-CoV-2 IgG (COV2G) antibody test, which is designed for use on Siemens’ Atellica instrument and Advia Centaur XP and XPT family of analyzers. In addition to offering a positive or negative result for IgG antibodies, this test also reports a numerical result expressed as an index value that enables clinicians to gauge the level of IgG antibodies in a patient’s blood sample. According to Siemens, the COV2G is the first FDA-authorized antibody test to perform this type of semi-quantitative detection. By providing a semi-quantitative result, this test will enable providers to assess changes in an individual’s immune response to the SARS-CoV-2 virus and determine how SARS-CoV-2 antibodies develop in an individual and persist over time. This test could also help to establish the level of IgG antibodies that could be protective against recurrent infection.

Roche Gets FDA Approvals for HIV-1/HIV-2 Test, Breast Cancer Co-Diagnostic

The Food and Drug Administration has approved two new tests from Roche: an HIV-1/HIV-2 qualitative test for use on the fully automated cobas 6800/8800 systems and the Ventana HER2 Dual ISH DNA Probe Cocktail companion diagnostic. The cobas HIV-1/HIV-2 qualitative test uses polymerase chain reaction to simultaneously detect and differentiate between HIV type 1 (HIV-1) and type 2 (HIV-2) RNA in human serum and plasma. The Ventana HER2 Dual ISH DNA Probe Cocktail assay, on the other hand, identifies breast cancer patients with HER2 amplification, a biomarker that indicates they could potentially benefit from Herceptin (trastuzumab) therapy. This assay is a ready-to-use brightfield dual in situ hybridization (ISH) system that returns same-day results and can be read using light microscopy, eliminating the need for a specialized fluorescence microscope. Additionally, the test is designed for use with the Ventana Silver ISH DNP detection kit and the Ventana Red ISH DIG detection kit on the fully automated BenchMark Ultra.

FDA Approves Foundation Medicine’s Liquid Biopsy Companion Diagnostic

Foundation Medicine has received Food and Drug Administration (FDA) approval for FoundationOne Liquid CDx, a pan-tumor liquid biopsy test. This test is a companion diagnostic that identifies patients who could benefit from treatment with specific FDA-approved targeted therapies, including an indication for Rubraca (rucaparib), a poly (ADP-ribose) polymerase inhibitor for the treatment of patients with BRCA 1/2-mutant metastatic castration-resistant prostate cancer, and three first-line tyrosine kinase inhibitors for the treatment of non-small cell lung cancer. The FoundationOne Liquid CDx is also approved for use as a comprehensive genomic profiling test to aid in the management of patients with any solid tumor. For this purpose, it reports genomic alteration results for more than 300 cancer-related genes, including genomic signatures such as blood tumor mutational burden and high microsatellite instability, as well as single gene alterations and all NTRK gene fusions.

CE Mark Granted to NeuMoDx Molecular for BK Virus Test

NeuMoDx Molecular has received CE mark approval for its quantitative BK virus (BKV) polymerase chain reaction (PCR) assay, which was developed in collaboration with Sentinel Diagnostics. BKV primarily affects immunocompromised individuals, such as those who have undergone organ transplantation, and this test will expand upon NeuMoDx’s menu for transplant patients, which already includes CE-marked assays for Epstein-Barr virus and cytomegalovirus viral load monitoring. The BKV PCR assay is based on Sentinel Diagnostics’ patented STAT-NAT technology and is supplied in a ready-to-use lyophilized format. The NeuDry reagents used with the test require no refrigeration and have an on-board stability of up to 60 days, as well as an ambient temperature shelf life of greater than 1 year. Like other NeuMoDx tests, the test also integrates the entire molecular diagnostic process from extraction to detection, with initial results available in about 1 hour.