Sekisui Launches FDA-Cleared COVID and Flu Combo Test

Sekisui Diagnostics has launched a rapid nasal-swab test that can distinguish COVID-19 from influenza A and influenza B in a single procedure. The product enters the market with FDA 510(k) clearance and a CLIA waiver for point-of-care use.

The OSOM COVID-19/Flu A&B Combo Test is intended for people showing symptoms of a respiratory infection. It detects viral antigens from an anterior nasal swab and reports qualitative results, meaning it identifies whether each target is present rather than measuring the amount of virus.

The FDA's CLIA database lists the test under document K243561 and records the waiver as effective on August 26, 2026. That status allows the assay to be used in eligible waived settings, expanding access beyond high-complexity laboratories. Sekisui says the test is manufactured in the United States and designed for professional healthcare settings.

The commercial pitch includes a built-in quality-control feature. Sekisui says its QC Inside system avoids the need to buy separate external control material and leaves two additional patient tests available for quality-control procedures. That is a claimed operating-cost advantage, although the company did not disclose price, expected volume or revenue.

The timing is relevant because overlapping symptoms make clinical differentiation difficult during respiratory-virus season. A combined test can reduce the need for separate assays and may help clinicians decide which treatment or follow-up is appropriate. It does not replace clinical judgment, and a negative antigen result may still require confirmation depending on symptoms and public-health guidance. The release did not provide sensitivity or specificity figures suitable for a performance comparison.

For investors assessing diagnostics companies, clearance and waiver remove important regulatory barriers, but they do not establish commercial success. Adoption will depend on test accuracy in practice, reimbursement, distribution, pricing and competition from other multiplex assays. Sekisui did not provide sales guidance, so the launch is a product-access milestone rather than a quantified earnings catalyst.