Today, Sekisui Diagnostics announces the launch of three new rapid tests as additions to the OSOM portfolio. Providing accurate results with minimal hands on time, OSOM Ultra Flu A&B and OSOM Ultra hCG Combo complement the existing Flu and hCG product lines, while the OSOM iFOB provides a new diagnostic option for fecal occult blood testing.
The OSOM Ultra Flu A&B Test provides qualitative results in 10-15 minutes by utilizing a simple assay procedure with minimal hands-on time. The Ultra Flu A&B Assay provides accurate results for both Flu A and Flu B viral infections across multiple sample types. The OSOM Ultra Flu A&B Test is projected to meet the currently pending FDA reclassification requirements for Rapid Flu Tests in the US Market.
The OSOM Ultra hCG Combo Test provides qualitative hCG results in 3-5 minutes utilizing a single-step procedure with less than 30 seconds of hands-on time. In studies, the Ultra hCG Combo assay demonstrated highly accurate results with 100% sensitivity and 100% specificity for urine samples and 100% sensitivity and 99% specificity for serum samples. The OSOM Ultra hCG Combo Test also detects hCG β-core fragments, reducing the risk of interference when testing urine samples from later stages of pregnancy.
The OSOM iFOB Test provides qualitative results in 5-10 minutes utilizing a simple assay procedure requiring less than 1 minute of hands-on time. Results indicate the presence of fecal occult blood in human samples, which aids in the diagnosis of colorectal cancer. The OSOM iFOB Assay provides highly accurate results specific to human hemoglobin which eliminates dietary or drug restrictions for the patient prior to testing. The design of the test also offers the patient a simple and convenient method for collection and return of their sample, which can be a significant barrier to compliance.
"Sekisui Diagnostics is delighted to be launching these three new products to complement our successful OSOM product line," says Lee Lipski, Vice President of Global Sales and Marketing, Sekisui Diagnostics. "We are focused on continuing to deliver innovative products and are confident that the new OSOM Flu, iFOB, and hCG tests will help improve patient care by expanding the menu and benefits of our OSOM Rapid Test portfolio."
Rapid /Point-of-Care Testing is both a growing and highly relevant area of diagnostics, especially with the increased focus on efficient diagnosis and cost management through rapid and effective treatment.
The three new OSOM products will be initially launched in the United States through our current distribution partners, with the potential to expand internationally in the future.
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