From DNA testing and risk-screening to kits that can detect early signs of serious complications like colon cancer, at-home health diagnostics are one of the latest innovations sparked by an increased demand in patient access to easy, affordable healthcare. Just last week, Amazon released its own FDA-approved COVID-19 test kit for direct sale to consumers. To meet the demand for fast, accurate results and address one of healthcare’s most marginalized communities, one Temple Health and Bioscience District (THBD) tenant company is addressing the sexually transmitted disease (STD) epidemic head-on.
Mia Mihailovic, Paul Amador, and Sam Mihelic are the engineers, and coincidentally best friends, behind ama biotech, a medical diagnostic company committed to delivering at-home STD testing kits to women. Born from a desire to help inform populations about their own health and increase access to needed screenings, the trio took inspiration from Amador’s last name to mark their research.
“In many languages and cultures,” explains Mihailovic, “‘ama’ is a root word for love. We want to make a point-of-caring diagnostic, especially for women, a population largely underrepresented in healthcare research. That’s what love and this tool mean to us.”
Asymptomatic infection, a concept made devastatingly popular by the COVID-19 pandemic, is particularly common for STDs in women. Unfortunately, long-term consequences of bacterial STDs like chlamydia, gonorrhea, and syphilis can lead to serious problems such as pelvic inflammation, infertility, and cervical cancer. The effects of undetected STDs, coupled with Centers for Disease Control and Prevention (CDC) data that shows bacterial STDs are at a staggering all-time high for the sixth consecutive year, led Mihailovic and her colleagues to develop at-home diagnostics specifically designed for women to use on a regular basis.
“Our product is a completely at-home STD test for menstruating women,” says Mihailovic. “There are other STD tests on the market that send a testing kit to the user but require the patient to send it back for third-party lab testing. Our concept is easier, faster, and more affordable.”
Similar to a pregnancy test, the ama biotech test delivers an at-home readout so patients can immediately understand which infections they may be carrying. Delivered at an affordable cost, these tests are designed with the at-risk population of sexually active women ages 15 to 24 in mind. Cost is increasingly becoming a barrier to health knowledge and care, with 70 percent of women in a research study showing a desire to be tested for STDs three times annually; most insurance only covers one annual test.
The ama biotech test empowers women to take stock of their health in a safe, comfortable environment – their own home. If the test indicates an infection, patients can then take the readout to their physician and discuss the next steps from there. Many STDs are bacterial infections, meaning they can be treated and in fact cured, with antibiotics, thwarting the long-term health effects left when these complications are left undetected or treated.
“Information is power,” says Mihailovic. “We aren’t here to judge anyone but to give people the knowledge they need to take care of themselves.”
In addition to identifying STDs, the ama biotech kit may help detect two other serious health issues that impact women: bacterial vaginosis (BV) and STD antimicrobial resistance.
“We realize that there may be another sort of market,” says Mihailovic, “for women suffering from extremely common problems. Some individuals are simply more susceptible to complications like BV.”
Antimicrobial resistance, defined by the World Health Organization (WHO) as, “The ability of bacteria, parasites, viruses and fungi to resist medicines,” is identified by the organization as a Top 10 threat to global health, that would increase human’s susceptibility to common illnesses. For example, due to its developed resistance to numerous antibiotics, gonorrhea (a bacterial STD) can now only be treated with one class of recommended antibiotics. As STD antimicrobial resistance continues to grow, it will be critical to diagnose rapidly to appropriately treat these infections the first time.
Nearly one-third of women ages 14 to 49 are estimated to carry BV, a non-STD inflammation that upsets the balance of natural microflora in the vagina. Like bacterial STDs, this condition is also treatable by a medical professional and early diagnosis can increase a patient’s comfort and overall self-care.
At THBD, the team is hard at work developing a minimal process handling feature, making the product easier for at-home use.
“Not everyone has a centrifuge at home,” jokes Mihailovic, with a nod to THBD’s state-of-the-art laboratory equipment. “We have access to quantify the concentration of biomolecules and readings of these biotests that we could not have seen without these tools.”
Stay tuned for more developments on the ama biotech team’s research and progress, as well as other tenant and biotechnology resource news at templebioscience.org.