Gene test for antibiotic resistance gets FDA breakthrough nod
- A fast test to detect whether a patient has genes resistant to antimicrobial drugs has received FDA breakthrough device status. The designation is intended to speed development and review of a technology that could offer a more effective treatment for life-threatening conditions or irreversibly debilitating diseases.
- T2 Biosystems said its T2Resistance Panel can detect 13 resistance genes from a patient's blood sample in three to five hours, versus the three or more days it now takes to get results through conventional methods such as a blood culture or antimicrobial susceptibility test (AST).
- The company said the panel is expected to be available for research use only in the United States and to receive CE Mark for commercial use in Europe later this year.
Shares of T2 Biosystems, which focuses on development of diagnostics products for unmet medical needs, leaped 15.4% to $4.34 on the Nasdaq Thursday following the announcement of FDA's breakthrough designation.
The World Health Organization has identified antibiotic resistance, where bacteria change in response to overuse of the medicines and become harder to treat, as one of the biggest threats to global health.
A growing list of infections including pneumonia, tuberculosis, blood poisoning, gonorrhea and foodborne diseases are becoming more difficult to treat as antibiotics become less effective, the agency said. WHO has encouraged countries to develop national action plans to reduce antimicrobial overuse and misuse.
At least 2 million people get an antibiotic-resistant infection each year in the United States and at least 23,000 people die, according to the Centers for Disease Control and Prevention (CDC).
Because it can take several days to get results under the current standard of care for diagnosing bloodstream infections caused by antimicrobial-resistant pathogens, doctors may start patients on broad spectrum antibiotics before they know what exactly is needed, T2 Biosystems said. The new diagnostic panel is designed to expedite the diagnostic process so patients can get targeted treatment sooner. A faster diagnosis also can cut down on the unnecessary use of antimicrobial drugs.
The technology can detect both gram-positive and gram-negative pathogens for a single blood sample. The 13 genes identified on the panel include several that are listed on the CDC's urgent threat list for antibiotic resistance.
CDC said it is working to release an updated Antibiotic Resistance Threats report in fall 2019.
The T2Resistance panel was developed with the help of funding from the HHS Biomedical Advanced Research and Development Authority; the U.K-based Wellcome Trust charitable foundation; and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Lexington, Massachusetts-based T2 Biosystems also makes the T2Bacteria and T2Candida panels, which are FDA-cleared for detection of sepsis-causing pathogens from whole blood samples.