Design as a Platform for Future Assay Tests : 33

Astek Diagnostics is a Baltimore-based MedTech startup developing a platform for diagnosing urinary tract infections (UTIs) with unprecedented speed and accuracy.

In Episode #33, Key Tech’s Andy Rogers and Lauren Eskew discuss this exciting development with Astek Diagnostics co-founder and CEO Dr. Mustafa Al-Adhami.

Need to know

• UTIs are proliferating — Within thirty years, global cases rose 90% to over 400 million cases[CC1] , with over 8 million hospital visits in the US alone.
•  Rapid tests are unreliable — Low-specificity dipsticks have high false-positive rates.
• Clinical tests are slow — Labs take up to three days to return results.
• Incorrect prescriptions are common — Physicians initially choose the wrong antibiotics in half of patients, delaying effective treatment.
• UTI complications are lethal — 25% of sepsis cases start as UTIs, leading to 68,000 deaths in the US[CC2] .
• Slow, inaccurate diagnoses breed resistant bacteria — Delaying the use of effective antibiotics contributes to the severe threat of antimicrobial resistance.

The nitty-gritty

Dr. Al-Adhami’s entrepreneurial journey began with a personal crisis two months before receiving his biomedical engineering Ph.D. when his grandfather developed a UTI.

“It took the doctors four days to tell him what antibiotic he should be using,” Dr. Al-Adhami said. “In the meantime, he was in pain. He was delirious. He fell and broke his hip. I kid you not, he was a young 87-year-old. Within one week, he was a much, much older, bedridden 87-year-old. [While] helping with his care, I was like, if we were able to give him the proper antibiotic right away, we would not be here!”

Such strong motivation led to a one-hour test for use in a urology or OB/GYN clinic. The system has two components: a single-use sample cartridge and a durable microfluidics fluorescent analyzer that characterizes antibiotic susceptibility[CC3] . Astek’s tabletop prototype already achieves 97% specificity and 94% sensitivity — results that would revolutionize UTI treatment worldwide.

Data that made the difference

Working with Key Tech, Dr. Al-Adhami’s team will soon have an alpha product ready to begin feasibility studies. Shortly afterward, the beta design will enter clinical trials with a planned FDA submission by the second quarter of 2025 — a remarkable four years after the company’s founding.

“The patients are waiting, right?” Dr. Al-Adhami pointed out. “Luckily, my grandfather is still with us. The goal here is to help with my grandfather's situation, so I need to get this to market as soon as possible.”

While Dr. Al-Adhami and co-founder Kevin Tran saw the market need, they needed data from their first prototype to show potential investors. “We ran fifteen samples, and the device was spot on with thirteen of the fifteen. It was like, this works! This is not a bad idea! I was confident enough to raise a pre-seed round. To say, ‘Hey, angel investor, can I have 50K?’”

Further market research helped shape pricing and reimbursement models that benefit the company and physicians.

“More importantly,” Dr. Al-Adhami said, “the patient is getting better. That makes it sustainable. The idea here is to shorten the [hospital stay]. We did a health economics study. If we shorten the stay [for all patients] by one day, we’re saving the hospital — per site — a million dollars a day.”

Watch the full video below for more details and to hear Dr. Al-Adhami’s advice for MedTech founders.

 [CC1]From Key Tech/Astek press release

 [CC2]From Astek’s website

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