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T2 Biosystems & Canon Collaborate to Develop Lyme Disease Diagnostic Test

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T2 Biosystems, Inc. has entered into a multi-year, strategic agreement with Canon U.S. Life Sciences, Inc. to jointly develop a novel diagnostic test panel to rapidly detect Lyme disease, a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders and cognitive defects.

Under the terms of the agreement, T2 Biosystems will receive an upfront payment of $2 million from Canon U.S. Life Sciences and additional milestone payments upon achieving certain developmental and regulatory milestones for total payments of $8.5 million. T2 Biosystems will retain exclusive worldwide commercialization rights of any products developed out of the collaboration, including sales, marketing and distribution. Canon U.S. Life Sciences will receive royalty payments on all product sales resulting from the collaboration and both companies will explore operational areas to work together and additional diagnostic product opportunities in the future.

"We are thrilled to enter into this collaboration with Canon U.S. Life Sciences to address the significant unmet market need in the detection of Lyme disease utilizing our T2MR technology platform," said John McDonough, president and CEO of T2 Biosystems. "Similar to T2Candida, our first FDA-cleared diagnostic panel for the detection of sepsis pathogens, blood culture is the current gold standard for testing patients suspected to have Lyme disease, but has many limitations, including often taking weeks to diagnose. We believe T2MR may be able to provide accurate results in hours instead of weeks, which could positively impact outcomes for patients and reduce the cost of Lyme disease to the healthcare system. We look forward to partnering with Canon to work towards developing and bringing this important diagnostic test panel to market."

According to The Centers for Disease Control and Prevention (CDC), Lyme disease affects approximately 30,000 people in the U.S. each year. However, the CDC estimates that the actual number is closer to 360,000, but is under-reported due to poor diagnostic testing. Approximately 3.4 million tests are run for Lyme disease each year, including serology testing, polymerase chain reaction (PCR) techniques and blood culture, the current diagnostic standard of care, but which has low sensitivity and takes approximately two to three weeks to provide results.

"Canon U.S. Life Sciences is dedicated to developing innovative new diagnostic solutions that improve human health," said Akiko Tanaka, vice president and COO, Canon U.S. Life Sciences, Inc. "We believe combining our collective expertise with T2 Biosystems' proprietary T2MR platform may enable us to develop a fully differentiated diagnostic panel for the detection of Lyme disease, an area of critical need where delays in providing appropriate treatment to patients can result in significant morbidity and unnecessary costs. We look forward to collaborating with T2 Biosystems on this exciting area of development."