Tag Archives: Sekisui Diagnostics

April 2024—Sekisui Diagnostics has received emergency use authorization for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings. The lateral flow immunochromatographic assay is intended for the qualitative detection and differentiation of influenza A and B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen. The test is for in vitro diagnostic use.

March 13, 2024—Sekisui Diagnostics received EUA clearance for its Osom Flu SARS-CoV-2 Combo test for use in professional and home testing settings.

February 2024—Sekisui Diagnostics formalized an exclusive distribution agreement with Aptitude Medical Systems to sell the Aptitude Metrix COVID-19 test in the United States. The EUA-approved, single-use molecular in vitro diagnostic test is for the qualitative detection of nucleic acid from SARS-CoV­-2 using anterior nasal swab and saliva samples.

Jan. 4, 2024—Sekisui Diagnostics formalized an exclusive distribution agreement with Aptitude Medical Systems to sell the Aptitude Metrix COVID-19 test in the United States.

June 2018—Sekisui Diagnostics has partnered with Qualigen to distribute the FastPack IP System, Qualigen’s POC immunoassay testing system.

February 2018—Sekisui Diagnostics and Mesa Biotech announced a strategic alliance to distribute the Mesa Biotech POC molecular system for Flu A/Flu B. Sekisui Diagnostics will assume exclusive distribution of the Mesa Biotech POC system in the United States and Canada, pending FDA clearance.

October 2016—Sekisui Diagnostics and Qualigen announced a strategic partnership encompassing current business and future collaboration opportunities. Sekisui Diagnostics has assumed commercial activities and distribution management for the FastPack IP System and associated products in U.S. and international markets.

Sekisui Diagnostics launched the Sekure brand of clinical chemistry reagents. Sekisui develops, manufactures, and supplies clinical chemistry reagents and systems to the in vitro diagnostics industry, selling more than 1.5 billion clinical chemistry tests per year.

Sekisui Diagnostics’ OSOM rapid immunochemical fecal occult blood test detects hemoglobin in stool samples as an aid in the early detection of colorectal cancer. The OSOM test provides sample stability: a unique “dry-sample” collection card; value: two patient sample collections on one collection card allow compliance with screening guidelines, using only one test cassette; and a comprehensive physician and patient support Web site.