T2 Biosystems wins FDA breakthrough nod for drug resistance blood test

T2 Biosystems (NSDQ:TTOO) said yesterday that it won FDA breakthrough device designation for its T2Resistance Panel diagnostic designed to detect 13 drug resistance genes from a blood sample.

The T2Resistance Panel is designed to identify 13 genes that the Lexington, Mass.-based company said include “the most clinically important.” This includes genes that indicate a resistance to antimicrobial drugs that can significantly affect the treatment of bacterial infections and several genes listed on the CDC’s Urgent Threat list for antibiotic resistance, T2 said.

The system is intended for use on both gram-positive and gram-negative pathogens from a single patient blood sample and eliminates the need to wait for blood culture, the company added.

“Under the current standard of care, diagnosing bloodstream infections caused by antimicrobial resistant pathogens requires a positive blood culture and subsequent analyses to determine exactly what medication will most effectively treat the infected patient. These conventional methods, including blood cultures and antimicrobial susceptibility testing, take 3 or more days to provide an actionable result. This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need,” medical affairs VP Sandy Estrada said in a prepared statement.

T2 Biosystems said that it expects the T2Resistance Panel to be available for research use only in the U.S. later this year, and that it is hopeful for CE Mark approval in the European Union and commercial availability in the region during the same time frame.

“We’re grateful to the FDA for bringing us one step closer to getting the T2Resistance Panel in the hands of clinicians across the country. With the introduction of this panel, the T2 product portfolio will continue to expand to enable clinicians to make fast, accurate treatment decisions for the more than 2 million people who get an antibiotic-resistant infection each year in the United States alone,” prez & CEO John McDonough said in a press release.

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