The first infection diagnostic emerges from Carb-X

A tool that can identify infections within hours is the first diagnostic product to emerge from the Carb-X partnership and could be the first of its kind to market.

T2 Biosystems, based in Lexington, Massachusetts, created the diagnostic, called the T2 Resistance Panel. It relies on nuclear magnetic resonance to identify pathogens in the bloodstream. Carb-X, a public-private venture that develops drugs, vaccines, and other products to tackle antibiotic resistance, awarded the company $2 million in 2017 to build the panel. T2 recently announced a contract worth up to $69 million from the US Biomedical Advanced Research and Development Authority to begin clinical trials.

“We see T2 being a real example of how diagnostics can help decrease the amount of time it takes to identify pathogens,” says Betsy Wonderly Trainor, who manages the diagnostics portfolio for Carb-X. She says T2 “demonstrates how diagnostics can guide the more appropriate use of antibiotics,” leading to shorter hospital stays and reduced health care costs.

Diagnosing bacterial infections typically involves culturing bacteria over several days from up to 20 ml of blood, T2 CEO John McDonough says. Testing that culture for antibiotic resistance adds more time.

The T2 test uses a fraction of the blood sample and can detect just a few bacterial cells per milliliter of blood. The lysed blood sample is incubated with metal-based nanoparticles attached to DNA probes. The probes correspond to species-specific bacterial DNA as well as genes that encode antibiotic resistance. If the probes bind a target, the NMR signal changes, indicating infection. Amplifying the sequences of the probes identifies both the bacterial species and possible antibiotic resistance.

Knowing both the bacterial culprit and its genetic makeup allows clinicians to make more rapid decisions about which antibiotics to use to treat a person with an infection, cutting possible treatment time by days and reducing antibiotic use, McDonough says. Clinical trials will focus on sepsis, a bacterial illness that the US Centers for Disease Control and Prevention says causes one of every three hospital deaths.

The US Food and Drug Administration has given the product its breakthrough device designation, which could shorten its time to approval. The resistance panel will soon be available for research purposes, and McDonough says T2 is pursuing approvals in Europe. He says Carb-X’s support has shortened the firm’s development time and puts it in position to be the first to market with a bacterial diagnostic that does not require culture time.

“As a small company, we have limited R&D dollars. We’re perhaps as much as two years ahead of what the schedule would have been without Carb-X,” McDonough says.