UTIs drive roughly 10.5M office visits and 3M emergency department encounters in the US each year, and the standard workup starts with a urine culture. That culture detects only the fast-growing bacteria, so patients with recurrent infections, catheters, or negative results despite ongoing symptoms often cycle through repeat visits and rounds of antibiotics that fuel drug resistance. Biotia, a diagnostics company spun out of Cornell Tech, targets that gap with clinical metagenomics, a form of next-generation sequencing that reads pathogen DNA directly from a sample instead of waiting for bacteria to grow. Its flagship BIOTIA-ID Urine Test detects 44 urogenital pathogens and 16 drug resistance markers from a single urine sample with 97% sensitivity and 99% specificity, and the company runs it in its own CLIA-certified lab in Long Island City. Patients can order the test at home and review results with UTI specialists at telehealth partner Clinova Solutions, while clinicians can order it for their own patients in all 50 states, which gives both sides a pathogen-specific answer in 2 to 3 business days instead of another empiric prescription. Biotia now applies the same platform to women’s health through an STI and vaginal health panel and develops a joint fluid test for orthopedic infections with Hospital for Special Surgery.
AlleyWatch sat down with Biotia CEO and Cofounder Niamh O’Hara to learn more about the business, its future plans, recent funding round that brings total funding to $19.4M, and much, much more…
Who were your investors and how much did you raise?
Our investors included Convergent Ventures, DigitalDx Ventures, Cloquet Capital Partners, Continuum Health Ventures, I-Lab Angels, EGB Capital, Leawood Venture Capital, Red Bear Angels, Red Bear Ventures, the family offices of Tim Barry and Dr. Clive Fields, and others.
We raised $9M in oversubscribed financing as an extension to our Series A.
Tell us about the product or service that Biotia offers.
Biotia is a NYC-based health tech company advancing infectious disease diagnostics for patients managing challenging infections. We are leaders in the field of clinical metagenomics, which uses next-generation sequencing and bioinformatics to detect pathogens from different biological samples. Our flagship diagnostic test, the BIOTIA-ID Urine Test, identifies the cause of recurrent and complicated urinary tract infections (UTIs) with 97% sensitivity and 99% specificity while simultaneously offering insight into antimicrobial resistance, helping providers select and optimize treatment. We offer this test to patients through our test to treat service, providing them with an at-home collection kit and care provided by our telehealth partner, Clinova Solutions, who specialize in recurrent and complicated UTIs. It is also available for clinician-ordering by the patient’s own clinicians and in-person collection.
What inspired the start of Biotia?
Dr. Chris Mason and I launched Biotia from Cornell Tech, driven by personal frustrations with undiagnosed infections we each experienced (e.g. I got a hospital-acquired complicated UTI), and enabled by research we had been doing using next-generation sequencing. We asked the question “If we can use these powerful genomic tools in research, why aren’t they in the clinic?”
How is Biotia different?
Biotia is different from other infectious disease diagnostics companies due to our innovations in genomic tools we have developed specifically for chronic and complicated infections. We spun Biotia out of Cornell and spent years on R&D, clinical studies, developing patented innovations in lab protocols, pathogen databases, and analytic software. Our approach for implementing this technology in clinical practice differentiates us further: we are not a wellness brand. We take diagnostic and antimicrobial stewardship very seriously. For example, the BIOTIA-ID Urine Test is intended for patients experiencing UTI symptoms who meet the clinical criteria for recurrent UTI, complicated UTI, or have recently tested negative by standard urine culture. Patients are screened for this clinical criteria by providers from our telehealth partner, Clinova Solutions. This makes sure that the right patient gets the right test at the right time, reducing the risk of overdiagnosis, and subsequent inappropriate antimicrobial use, that other companies in our space often fail to mitigate.
What market does Biotia target and how big is it?
Biotia has a platform launching a number of infectious disease diagnostic assays for a number of very large markets. For our flagship assay, BIOTIA-ID Urine, the opportunity begins with one of the most common infections in medicine. Worldwide, UTIs have an estimated annual incidence of more than 150 million cases, and in the United States they drive roughly 10.5 million office visits, 3 million emergency department encounters, and 400,000 hospitalizations each year, at an estimated annual cost of over $4.8 billion. The patients who most need better answers make up a large, recurring share of that burden. Estimates of how many women go on to develop recurrent UTI range from about 14.5% to 40%, and 70% to 80% of complicated UTIs in the US are attributable to indwelling catheters, accounting for 1 million cases per year. These are exactly the high-risk, culture-negative, and hard-to-treat cases where standard culture falls short and sequencing-based diagnostics add the most value. Beyond urine, the same platform extends into women’s health through our STI and vaginal health panel, entering a global STD diagnostics market valued at $11.2B in 2023 and projected to reach $21.74B billion by 2032.
What’s your business model?
Biotia’s business model is built on a proprietary platform that pairs next-generation sequencing with AI-driven bioinformatics. We develop and run high-value infectious disease diagnostics in our own CLIA-certified, New York State–approved laboratory, and each new assay draws on the same lab infrastructure, software, and growing microbial database. That lets us launch new tests at low marginal cost. Revenue comes from several reinforcing channels. Clinicians order tests such as our flagship BIOTIA-ID Urine for complicated, recurrent, and culture-negative UTIs. Consumer-initiated testing (CIT) reaches patients directly, mediated by our telehealth partner. B2B partnerships bring our tests to women’s health companies, large employers, and health systems. We are working on getting insurance coverage for our tests.
How are you preparing for a potential economic slowdown?
As a startup, we are judicious and conservative in how we spend our capital. Regardless of an economic slowdown though, people will still need our testing and diagnostics as chronic complicated infections are pervasive. To ensure access to our tests, we are pushing forward obtaining reimbursement for the BIOTIA-ID Urine Test to reduce the out-of-pocket costs to patients.
What was the funding process like?
Fundraising for a diagnostics company is a marathon. Diagnostics sits at an interesting intersection for investors. It requires domain savvy investors who appreciate deep technology, lab infrastructure, regulatory approvals, clinical evidence, as well as understand the path to return on investment takes longer than in software or many other areas of health tech. What got us through was focusing on the investors who understood both the problem and the work it takes to solve it, and letting our milestones make the case for us. Each regulatory approval, clinical partnership, and new assay launch changed the conversation. The process also made us a much sharper company. Having to defend every assumption forced us to get clear on our business model, our evidence strategy, and where our platform creates the most value. We came out of it with an investor base that is aligned with how diagnostics companies are actually built, and that’s worth more than a fast round.
What are the biggest challenges that you faced while raising capital?
Some of the biggest challenges were a shifting landscape to raise in, in addition to the regulatory and reimbursement timelines that could delay deliverables at points.
What factors about your business led your investors to write the check?
Different key milestones we have achieved with a relatively small, lean team, our ability to pivot, and key partnerships we landed to scale.
What are the milestones you plan to achieve in the next six months?
Key milestones we plan to achieve in the next six months include scaling our team, receiving NYS CLEP approval for additional sample types to be used on the BIOTIA-ID platform, and making additional progress on getting insurance coverage for our assays.
What advice can you offer companies in New York that do not have a fresh injection of capital in the bank?
My biggest piece of advice is that staying in the game is a strategy in itself. Companies rarely fail because their idea was wrong. They fail because they ran out of time before the idea could prove itself. So make every dollar extend your runway toward the next milestone that changes your story, whether that’s a regulatory approval, a paying customer, or a key data readout. Narrow your focus to the few things that create the most value (sometimes easier said than done), and be honest about what can wait.. And find revenue early, even if it’s modest. Revenue buys time and proves demand, and it puts you in a much stronger position when you raise again.
Where do you see the company going now over the near term?
Over the near term, we will be going live with some major partnerships that have been enabled by our recent laboratory expansion. We are also continuing to push for reimbursement for the BIOTIA-ID Urine Test and are launching additional clinical studies to further assess how the test impacts patient’s health outcomes. In addition, we are developing assays in the orthopedics space to help diagnose joint infections.
What’s your favorite fall destination in and around the city?
Sleepy Hollow (just north of the city) has some great spooky shows this time of year!
