LEXINGTON, Mass., January 11, 2017 /PRNewswire/ – Today, Sekisui Diagnostics announces the launch of the OSOM® BVBLUE® Test in Europe, Middle East and North Africa. The OSOM® BVBLUE® Test, which is used in the diagnosis of bacterial vaginosis (BV), is now CE marked. The test provides accurate results with minimal hands on time through detection of elevated levels of the enzyme sialidase produced by the four major pathogens associated with the condition.
The OSOM® BVBLUE® Test, combined with the OSOM® Trichomonas Test, provide comprehensive diagnostic tools for two of the most common vaginal and sexually transmitted infections in the world. “Worldwide, it is estimated that 20 –30 % of women of reproductive age attending sexually transmitted infection (STI) clinics suffer from BV, the prevalence of which can be as high as 50–60 % in high-risk populations”.1
The OSOM® BVBLUE® Test delivers fast, accurate results in 10 minutes by utilizing a simple procedure with less than one minute hands on time. The ability to rapidly diagnose a BV infection is beneficial to the patient in order to begin immediate and proper treatment, while reducing the chance of serious health complications.
In studies, the OSOM® BVBLUE® Test demonstrated highly accurate results with 92.8% sensitivity and 98% specificity vs. Gram Stain, with the added benefit of objective result interpretation. Along with the accuracy of the results, the OSOM® BVBLUE® Test provides economic benefits by helping to reduce the intensive labor and also the need for advanced expertise required to perform and interpret Gram Stains by microscopy.
“Sekisui Diagnostics is committed to providing products that can have a direct impact on the improvement of patient care,” says Lee Lipski, Vice President of Global Sales and Marketing, Sekisui Diagnostics. “Building on the successful adoption of this test in the US, we are pleased to be able to offer the OSOM® BVBLUE® Test internationally, which now enables physicians and laboratories in those countries to offer simple and efficient testing for both bacterial vaginosis and trichomonas infections.”
Along with these women’s health products, Sekisui Diagnostics provides a broad line of OSOM® rapid tests for Influenza, Strep A, Mononucleosis, Helicobacter pylori, hCG and Faecal Occult Blood. Sekisui’s Diagnostics 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. 2
About Sekisui Diagnostics
Sekisui Diagnostics is a global diagnostics company committed to improving patient lives by providing innovative medical diagnostic products to physicians and laboratories, as well as diagnostics manufacturers through a global distribution network. Product lines include clinical chemistry and coagulation systems and reagents, infectious disease testing and rapid test kits, as well as enzymes and specialty bio-chemicals.
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1Bautista et al. Military Medical Research (2016) 3:4
2Enterprise Analysis Corporation, IVD Market Research 2016
OSOM is a registered trademark of Sekisui Diagnostics, LLC.
BVBLUEis a registered trademark of Gryphus Diagnostics, LLC.
FastPack is registered trademark of Qualigen Inc
Because every result mattersTM is a trademark of Sekisui Diagnostics, LLC