Sekisui Diagnostics Announces OSOM® Ultra Flu A&B Test is now CLIA Waived

Sekisui Diagnostics announces the U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) Waiver status for the OSOM® Ultra Flu A&B Test using swab samples.  

The OSOM® Ultra Flu A&B Test delivers fast, accurate results in 10-15 minutes by utilizing a simple procedure across multiple sample types, including nasal swabs, nasopharyngeal swabs, and in moderate settings, nasopharyngeal aspirate/wash.  The performance of the OSOM® kit by users at CLIA waived sites was measured against the preferred standard of polymerase chain reaction (PCR), with a Positive Percent Agreement of 89.2% for Flu A and 86.4% for Flu B and Negative Percent Agreement of 99.4% for Flu A and 99.0% for Flu B.

According to the CDC Foundation, there are approximately 31.4 million outpatient visits and 200,000 hospitalizations each year related to influenza.[1] An estimated 20 million rapid tests have been performed in the U.S. each year since 2013, with a projected 4.5% CAGR through 2019. ]2,3]

CLIA waiver designation will enable healthcare providers to perform the OSOM® Ultra Flu A&B Test using nasal or nasopharyngeal swabs, to deliver simple and accurate test results in locations such as the emergency room, community-based settings, urgent care and physician offices. By using the OSOM® Ultra Flu A&B Test healthcare practitioners will provide patients with a rapid, accurate diagnosis while on site, thereby helping prevent unnecessary antibiotic prescriptions, reduce hospitalization, and minimize influenza transmission. [4]

"The excellent performance benefits of the CLIA Waived OSOM® Ultra Flu A&B Test will aid in the fast, accurate  detection of influenza through an easy to use product that provides physicians and patients the convenience of rapid results and treatment in one visit," says Robert Schruender, President and Chief Operating Officer of Sekisui Diagnostics.  "The test complements our other OSOM® CLIA waived rapid diagnostic tests and is another example of meeting our promise to our customers to deliver the products they need."

Along with influenza, Sekisui Diagnostics provides a broad line of OSOM® rapid tests for Strep A, Mononucleosis, Trichomonas, Bacterial Vaginosis, Helicobacter pylori, hCG and Fecal Occult Blood.  Sekisui's expanding Point-of-Care product line also includes the FastPack® IP System, which offers a convenient, rapid, decentralized testing solution for Vitamin D, Testosterone, PSA, Free PSA, TSH, Free T4, and hCG.

Point-of-Care Testing (POCT) is a highly relevant and growing area of diagnostics, particularly due to the increased focus on cost efficiency through rapid and appropriate treatment. Market analysis and consulting firm Enterprise Analysis Corporation estimated the global market for POC testing at $5,924 million in 2015. [5]

1. http://www.cdcfoundation.org/businesspulse/flu-prevention-infographic
2. GHX data
3. Kalorama 2014 Physician Office Laboratory Markets
4. Theocharis, George.Vouloumanou, Evridiki et al."Evaluation of a direct test for seasonal influenza in outpatients", European Journal of Internal Medicine, Vol. 21(2010) 434-438.
5. Enterprise Analysis Corporation, IVD Market Research 2016.