LabReady

Houston medical device startup enters clinical trials

LabReady ensures samples make it from the patient to the lab without compromising the quality of the sample. Photo via vaximmune.com

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.

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Koda Health, Houston, uses AI to help guide difficult conversations in health care, starting with end-of-life care planning. Image via kodahealthcare.com

A new Houston-based digital advanced care planning company is streamlining some of the most difficult conversations in the health care industry around palliative care.

Founded by Tatiana Fafanova, Dr. Desh Mohan, and Katelin Cherry, Koda Health uses AI to help patients create advance medical care directives and documents—such as a living will—through an easy to use web-based interface.

Koda Health uses a conversational platform where users can enter information about their values, living situations, quality of life wishes, and more while learning about different care options at their own speed. It also uses a proprietary machine learning approach that personalizes audio-video guided dialogue based on the patient's individual and cultural preferences.

The app then autogenerates legal and medical documents, which patients can notarize or electronically witness the forms through the app or on their own.

According to Fafanova, who earned her PhD in in Molecular Medicine at Baylor College of Medicine in Houston and now acts as the company's CEO, what historically has been a time consuming and expensive process, through Koda Health, takes an average of 17 minutes and is completely free of charge to the end user.

"We hope to reduce any outstanding barriers to access that might exist," Fafanova says. "It is very frequently the oldest and the poorest that are the highest utilizers of health care that don't have access to these solutions."

The app is also projected to save health care systems roughly $9,500 per patient per year, as it allows for hospitals and organizations to better plan for what their patient population is seeking in end-of-life-care.

The B2B platform was born out of the TMC's Biodesign Fellowship, which tasked Koda's founding members with finding solutions to issues surrounding geriatric care in the medical center. In March 2020, Koda incorporated. Not long after ICU beds began to fill with COVID-19 patients, "galvanizing" the team's mission, Fafanova says.

"It was no longer this conceptual thing that we needed to address and write a report on. Now it was that people were winding up in the hospital at alarming rates and none of those individuals had advanced care planning in place," she says.

After accelerating the development of the product, Koda Health is now being used by health care systems in Houston, Texas, and Virginia.

The company recently received a Phase I grant of $256,000 from the National Science Foundation, which will allow Koda to deploy the platform at Atrium Health Wake Forest Baptist and test it against phone conversations with 900 patients. Fafanova says the company will also use the funds to continue to develop personalization algorithms to improve Kona's interface for users.

"We want to make this a platform that mimics a high quality conversation," she says.

After Koda completes the Phase I pilot program it will then be eligible to apply for a Phase II award of up to $1 million in about a year.

Koda Health was founded by Tatiana Fafanova, Dr. Desh Mohan, and Katelin Cherry. Photos via kodahealthcare.com

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