LabReady aims to revolutionize the diagnosis of infectious diseases

Diagnosing infections is both costly and rife with opportunities for human error. Poorly managed lab samples can lead to inaccurate test results, which could mean sickness and additional medical costs.

Vax-Immune Diagnostics, a member of the 2018 TMCx medical device cohort and a JLABS @ TMC resident, has created LabReady, a hand-held, portable, disposable device designed to maintain an ideal environment for samples as they are transported from the patient to the lab for testing.

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The “lab in a bottle” collects, protects, processes and prepares samples so that when they arrive in the lab, potential infections are ready to be diagnosed. Using the current transport system—which has been in place for the last 85 years—samples are handed off between multiple parties and require continuous preservation on ice. With LabReady, as soon as the sample is inserted into the device, an incubation period begins.

“With our device, the enrichment process that currently doesn’t happen until the sample gets to the lab happens during transport. All the lab has to do is open it up and do the test,” said Leonard E. Weisman, M.D., president and CTO of Vax-Immune and a neonatal physician who worked for Texas Children’s Hospital. “You get less false negatives. You’re not testing samples where the bugs are dead or where there’s such a small amount they weren’t found.”

LabReady is wrapping up a clinical trial analyzing results from group B streptococcus (GBS) lab tests of pregnant women. GBS can be transmitted to newborns during birth and can cause complications, which could lead to death or long-term neurological issues. But with accurate diagnostic tests, Weisman said, “it’s a totally preventable disease.”

In a second generation of the device, Vax-Immune is working on an at-home product that would allow patients to diagnose their infections—including the flu or strep throat—without visiting a doctor