The United States is currently experiencing the most severe flu season in recent years, according to the CDC, with widespread activity and high influenza-like illness (ILI) across the majority of the country. The Silaris test allows urgent care, physician offices, hospitals and other facilities to implement an affordable, CLIA Waived, molecular testing option to diagnose and treat patients quickly which is key to minimizing the spread of the virus. The Silaris™ test offers the simplicity, convenience and procedural familiarity of traditional visual read rapid tests, while providing the superior sensitivity and specificity of laboratory-based PCR testing. The test is indicated for use with nasal swabs which are less invasive than other sample types and allows for a more comfortable experience for the patient.
"We are very excited to announce the launch of the Silaris™ product because it brings a unique diagnostic tool to the marketplace. Healthcare professionals can feel more confident they are treating patients accurately and quickly which is critical, especially during heavy flu seasons," said Robert Schruender, President & CEO of Sekisui Diagnostics. "This system is highly complementary with the rest of our point-of-care product line and illustrates our commitment to deliver innovative products which improve patient care."
Sekisui Diagnostics entered into a strategic alliance with Mesa Biotech in November 2017 for exclusive product distribution rights in the U.S. and Canada. This allows Mesa to leverage Sekisui Diagnostics' established sales/distribution channels and strong reputation among healthcare providers and provide immediate access to distribution channel partners.
"The influenza product is the first assay on our PCR testing platform to receive FDA clearance," said Dr. Hong Cai, co-founder and CEO of Mesa Biotech. "This is an outstanding validation of our testing platform and we remain focused on additional product development and look forward to a long term commercial collaboration with Sekisui Diagnostics of our expandable system."
About Sekisui Diagnostics
Sekisui Diagnostics is a global diagnostics company committed to improving patient's lives by providing innovative medical diagnostics to physicians and laboratories through a global commercial network. Product lines include clinical chemistry and coagulation systems, reagents, rapid test kits, point-of-care systems as well as enzymes and specialty bio-chemicals.
About Mesa Biotech Inc.
Mesa Biotech designs, develops and manufactures next generation molecular diagnostic tests, bringing the superior diagnostic performance of nucleic acid PCR amplification to the point-of-care (POC). Mesa Biotech's Accula™ System consists of a portable, palm-sized dock and a disposable, assay-specific test cassette. This patented system will allow healthcare professionals to access actionable, laboratory-quality results at the POC with greater sensitivity and specificity than current infectious disease rapid immunodiagnostic tests. Mesa Biotech's technology development has been funded to date by a series of grants and private equity investments.