|John McDonough, CEO of T2 Biosystems|
T2 Biosystems ($TTOO) inked an $8.5 million deal with Canon U.S. Life Sciences to develop a rapid diagnostic test for Lyme disease, expanding its offerings and looking to carve a niche in a growing market.
Under the terms of the agreement, the Lexington, MA-based company will receive an upfront payment of $2 million from Canon U.S. Life Sciences and additional payments for reaching certain developmental and regulatory milestones. T2 will hold onto exclusive worldwide commercialization rights for any products developed from the partnership, and Canon U.S. Life Sciences will receive royalty payments on product sales. The companies will also "explore operational areas to work together and additional diagnostic product opportunities in the future," T2 said in a statement.
The test will use T2's proprietary T2MR technology to quickly scan for Lyme disease, offering an advantage over current screening methods. Approximately 3.4 million tests are run for Lyme disease each year, but the products often have low sensitivity and take up to three weeks to provide results. T2's test would whittle diagnosis time down to a few hours, improving patient outcomes and potentially reducing healthcare costs, CEO John McDonough said in a statement.
The partnership comes on the heels of more good tidings for T2, as the company looks to make headway with its diagnostic portfolio. In September, the company won FDA approval for its rapid diagnostic system for sepsis, riding on the tailwinds of its August IPO and moving forward on its path toward full commercialization for the product. The company's T2Dx device and T2Candida test can identify sepsis-causing pathogens from a whole blood specimen in four hours. All other FDA-cleared tests require cultured blood samples and take two to 5 days to process results.
Meanwhile, the 2012 Fierce 15 company is touting data from pivotal trials showing its test's efficacy in identifying fungal infections. Last month, T2 announced results for a large, multicenter clinical trial of the devices which found that T2Candida and T2Dx demonstrated a 91.1% overall sensitivity and 99.4% specificity. The mean time for a positive result was 4.4 hours, compared to just over 5 days for blood culture and species identification methods.
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