Houston medical device startup enters clinical trials
Houston-based Vax-Immune Diagnostics has commenced on a new multicenter clinical trial to roll out a specific lab test as a part of its LabReady product.
The 12-week study will analyze results from Group B Streptococcus lab tests in expecting mothers. Currently, 16 to 20 percent of pregnant women are affected by GBS, according to a news release, which will then infect their newborn through the childbirth process.
Vax-Immune's product, LabReady, enhances the transportation process of lab samples and aims to improve the quality of results in patients. The company is expected to report data from the trial this summer.
"Currently samples are not regulated through transport from the patient to the lab often causing inaccurate test results. And inaccurate test results can cause significant problems since medical decisions are based on these results," Dr. Leonard E. Weisman, president and chief technology officer at Vax-Immune Diagnostics, says in the release.
"Our device, LabReady collects, protects, processes, and prepares the sample from the patient through transport, so when it arrives at the laboratory, infection can easily and accurately be diagnosed."
This study is planned to randomize approximately 300 patients from 35 to 37 weeks of pregnancy, according to the release. GBS is the most common cause of infections such as sepsis, meningitis, and pneumonia among newborns. The Centers for Disease Control and Prevention, among other organizations, have launched efforts for screenings and tests to reduce cases of neonatal GBS disease.
Vax-Immune was a member of the Texas Medical Center's 2018 TMCx Medical Device cohort and pitched at the 7th TMCx Demo Day. The company is a JLABS @ TMC resident.