NEW YORK (360Dx) — Shares of T2 Biosystems soared today on news that the US Food and Drug Administration granted Breakthrough Device Designation for its T2Resistance Panel.
In morning trading on the Nasdaq, the company's shares were up more than 25 percent at $4.73.
T2 Bio's panel can detect 13 resistance genes from both gram-positive and gram-negative pathogens and from a single patient blood sample without waiting for a blood culture.
The 13 genes include the most clinically important because they are largely resistant to antimicrobial drugs that are crucial in the treatment of bacterial infections, including carbapenems, vancomycin, penicillin and more, in certain patients, T2 Bio said.
With the Breakthrough Device Designation, the firm will work closely with the FDA during the premarket review phase of obtaining regulatory clearance, to ensure patients can have access to the benefits of the diagnostic panel as soon as possible, the firm said. Eliminating blood culture knocks days off the diagnostic process and expedites accurate and targeted treatment for certain antibiotic resistant bloodstream infections, it 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. "This leads doctors to start their patients on broad spectrum antibiotics before they even know exactly what they need," Sandy Estrada, vice president of medical affairs at T2 Bio, said in a statement.
The T2Resistance Panel, which can provide results in less than 5 hours, is expected to be available for research-use only in the US and receive CE mark for commercial availability in Europe later this year, T2 Bio said.
Canaccord Genuity analyst Mark Massaro said in a research note that T2 Bio has told him that discussions with FDA about the test have just started, "thus timing is fluid, but we believe an FDA-cleared version of this panel is likely a couple of years away."
The firm noted that several of the genes detected by the panel are listed on the Centers for Disease Control and Prevention’s Urgent Threat list for antibiotic resistance.