S2E7 - LabReady, Set, Go: Accurately Diagnosing Infections Faster and From Home

Introduction

Meet Leonard (Lenny) Weisman, MD. Lenny is co-founder, President, and CTO of Vax-Immune™ Diagnostics, a Houston-based early-stage diagnostic technology company redefining the way infections are clinically diagnosed, enabling a more accurate early detection of infections. The company’s novel platform technology LabReady® was designed to revolutionize the microbiology industry’s outdated 85-year-old process of collecting, processing, transporting, testing and reporting of samples, leading to better accuracy, faster and more efficient streamlined process for clinical labs.

According to Lenny, the current process for diagnosing infections takes too long, costs too much, and is frequently unreliable, due in most part to the adverse conditions encountered by the sample as it moves from the patient to the laboratory. This results in 20 to 45% of microbiology tests that are inaccurate, depending on the infection. Additionally, as part of an effort to target one of the most vulnerable patient markets, the company’s initial focus is on serious infections impacting pregnant women and babies, initially a bug called group B streptococcus that’s been associated with sepsis, pneumonia, meningitis, and death in newborn infants and urinary tract and uterine infections in pregnant women. If the company is successful, it will not just lead to quicker, more accurate diagnosis of infection but could displace the more than $4-5 billion in lost costs due to the inaccuracy of microbiology tests, each year, in the US pregnancy and baby markets alone.

Lenny’s fight for improved infection diagnoses began decades ago. “As a child I always knew I wanted to be a physician,” he shares.  After 24 years in the US armed forces as a physician, Lenny was recruited back to Baylor College of Medicine, his medical school alma mater, “and I've been here, now, for 25 years,” he says. Armed with over three decades as a practicing and research neonatologist, experience in developing vaccines, antibodies, diagnostics, and his globally recognized work with newborns and infectious disease, Lenny decided to “go out and develop a vaccine and antibody for Ureaplasma,” while at Baylor and Texas Children’s Hospital. “And we actually did,” Lenny confirms. “We have a vaccine; we have a therapeutic antibody and a diagnostic antibody.” But, continues Lenny, “the problem was to take a vaccine or an antibody to market is probably anywhere from a 15 to 20-year commitment and a billion dollars or more.” So instead, Lenny and his team “made a diagnostic for this particular bug using the antibody we had developed.” The diagnostic, though successful at its core, needed more work and thus, Vax-Immune™ Diagnostics’ flagship platform device LabReady® was developed.

“LabReady® is a hand-held, portable, disposable device that collects, processes, prepares, transports, and diagnoses the sample [for infection testing for immediate reporting],” explains Lenny. He believes it will significantly reduce the loss of sample quality and time required from collection to testing and result in faster and more accurate infection diagnosis. Lenny adds that “the second-generation device will actually include the ability through Bluetooth to report to the patient or the physician the result of the test” and, he continues, “is the one that we think will be the most exciting and that will allow the patient to stay at home, diagnose and treat their infection.” “That, to me,” Lenny concludes, “is just the ultimate: you don't have to get up if you're sick and go into the doctor's office, you can do it basically from your home.”

As residents of Johnson & Johnson Innovation, JLABS (JLABS @TMC) and a graduate of the TMC Innovation Institute’s accelerator program, TMCx, both located in the largest medical center in the world, Texas Medical Center, Vax-Immune™ Diagnostics is primed for success with one of its six patents for LabReady® already approved by the US Patent and Trademark Office. “We have LabReady® ready for FDA testing, and we have our clinical sites, and our clinical protocol developed. So, we’re about to embark on our FDA-associated clinical study,” closes Lenny. “Our next milestone is to get FDA approval and to start sales for our first-generation device, LabReady®. Our second-generation device, the home testing device, MY LabReady® will be more of a two-year addition to that, so probably about three years from now.” From all of us at MedTech Strategist, we offer Lenny and the Vax-Immune™ team, congratulations and continued success!

AUTHOR’S NOTE: The market for Ureaplasma, though important, is limited, so the Vax-Immune™ team focused their initial product on improving the diagnosis of group B streptococcus (GBS), with four million women a year receiving this test in the US alone. The GBS test will be followed by tests for Ureaplasma, and many other pregnancy and non-pregnancy related tests for infection.

WATCH THE SHORT VIDEO INTERVIEW ABOVE TO LEARN MORE ABOUT LENNY, AND HOW VAX-IMMUNE™ DIAGNOSTICS IS MAKING AN IMPACT ON THE HEALTHCARE INDUSTRY.

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