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T2 Biosystems Announces Issuance of Patent Covering T2Candida® Assay


T2 Biosystems, a company developing direct detection products enabling superior diagnostics, announced the U.S. Patent and Trademark Office has issued a patent number US8409807 (the ‘807 patent) covering T2Candida® the Company’s flagship diagnostic test. T2Candida identifies sepsis-causing Candida species directly from whole blood at ~1CFU/mL sensitivity in approximately three hours compared with current methods that rely on blood culture and require two to five days. The patent describes the T2Candida test format and methodology to detect and identify Candida species in a whole blood sample.

“The highly sensitive and rapid T2MR® technology enables us to identify Candida cells directly within a blood sample even at low copy numbers eliminating time-consuming and costly sample preparation” said John McDonough President and CEO T2 Biosystems. “This piece of intellectual property adds further protection for T2 Bio’s breakthrough direct detection technology that we believe will have a profound impact on the diagnostic landscape for any molecular immunoassay or hemostasis target.”

The ’807 patent “NMR systems and methods for rapid detection of analytes” is the first patent to issue from a large patent family that describes proprietary assays and the core of the T2Dx system. The claims broadly describe the T2Candida diagnostic test. T2 Bio owns or has rights to over 20 worldwide patents protecting several of the Company’s assets including its T2MR technology T2Dx® instrument and various applications of the technology.

About Sepsis & Candidemia

Sepsis is a potentially life-threatening illness caused by the body’s severe reaction to infection by bacteria fungi viruses or parasites. It is one of the top 10 leading causes of death in the United States and each hour of delayed treatment increases the mortality of these patients by 8%. Candida is a fungal pathogen known to cause sepsis and it is associated with approximately 100000 cases of candidemia in the U.S. annually making it the fourth-leading cause of hospital-acquired infections. Currently candidemia has a 40% mortality rate which can be reduced to 11% with early identification of the specific species. Current detection methods rely on blood culture a process that can take two to five days before identifying a Candida infection. The T2MR® platform is able to detect species-specific Candida directly from whole blood without the limits experienced with optical detection technology even at low copy numbers and provide results in approximately three hours.

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