Evvy’s New Test Aims to Disrupt Decades-Old UTI Diagnostics

NEW YORK, NY – December 09, 2025 – For the tens of millions of women who experience a urinary tract infection (UTI) each year, the process is often a frustrating cycle of discomfort, guesswork, and delay. The standard of care—a urine culture that can take days to yield results—has remained largely unchanged for decades. Now, women’s health startup Evvy is making a bold move to disrupt this paradigm with the launch of its UTI+ Test, an at-home kit that leverages advanced technology to deliver precise results in just one business day.

The company's entry into the UTI space represents a significant strategic expansion, moving from its foundation in vaginal microbiome analysis to tackling one of the most common infections affecting women. By promising not just a diagnosis but a roadmap for targeted treatment, Evvy is betting that patients and clinicians are ready to trade the slow, often inaccurate, culture method for a faster, more expensive, but potentially more effective solution.

The Diagnostic Dilemma

The persistence of the standard urine culture as the primary diagnostic tool is a well-known pain point in medicine. These tests, which involve growing bacteria from a urine sample in a lab, can miss up to 70% of pathogens according to some studies. They are particularly poor at identifying slow-growing organisms, polymicrobial infections (those caused by multiple types of bacteria), and infections in patients who may have already started an antibiotic. The result is a high rate of diagnostic failure.

This inefficiency has direct business and health consequences. When a diagnosis is delayed or incorrect, patients suffer longer, leading to repeat doctor visits, lost productivity, and increased healthcare utilization. Furthermore, it often results in physicians prescribing broad-spectrum antibiotics as a first-line defense—a practice that contributes to the escalating global crisis of antibiotic resistance. Evvy’s own data underscores the scale of the problem, noting that nearly half of women may receive an antibiotic that isn’t effective for their specific infection.

“At Evvy, we believe women deserve better than guesswork,” said Dr. Kate McLean, OBGYN and Chief Medical Officer at Evvy, in the company’s launch announcement. “We designed the UTI+ Test to solve a big failure of current UTI care: incomplete detection.”

A Technological Leap Forward

At the core of Evvy’s strategy is Polymerase Chain Reaction (PCR) technology. While PCR became a household name during the COVID-19 pandemic, its application in UTI diagnostics offers a powerful alternative to traditional methods. Instead of waiting for bacteria to grow, PCR rapidly amplifies and detects the specific DNA of pathogens present in a sample. The Evvy UTI+ Test uses this technology to screen for 12 key uropathogens and, crucially, 7 genetic markers for antibiotic resistance.

This two-pronged approach is the test's main value proposition. First, its speed—delivering results in one business day—dramatically shortens the feedback loop between testing and treatment. For eligible patients, this can mean receiving a same-day targeted prescription. Second, by identifying resistance genes, it provides clinicians with critical data to select an effective antibiotic from the outset, moving away from the trial-and-error approach.

Scientific literature increasingly supports the use of PCR for its superior sensitivity, with studies showing it can detect pathogens in a significant percentage of samples that are deemed negative by standard cultures. This is particularly relevant for the 1 in 4 women who suffer from recurrent UTIs, a group for whom a missed or incorrect diagnosis can lead to a chronic and debilitating cycle of infection. Evvy further connects this to its foundational research, noting that its data shows nearly half of its users with a recent UTI also had UTI-related bacteria detected in their vaginal microbiome—highlighting the potential for an integrated diagnostic ecosystem.

The Business of Precision Health

Evvy is positioning itself not just as a test provider, but as an end-to-end precision health platform. However, this advanced approach comes at a premium. Priced at $248 for a single test ($218 with a subscription), the Evvy UTI+ Test is substantially more expensive than both over-the-counter dipstick tests (typically under $25) and traditional urine cultures, which can cost as little as $8 for Medicare claims. This positions Evvy in a competitive but complex market.

Its direct competitors are not the cheap dipstick tests, but other labs offering advanced molecular diagnostics. Companies like Pathnostics and Devansh Lab Werks also offer multiplex PCR panels for UTIs, often with similarly high price tags. The key challenge for this entire category is demonstrating a cost-benefit that justifies the price. While Medicare and some private insurers have begun covering these advanced tests, the reimbursement landscape is fragmented and often requires strict clinical justification. This leaves many patients paying out-of-pocket.

Evvy’s direct-to-consumer model bypasses some initial gatekeeping but places the financial decision squarely on the patient. The company’s strategy appears to be targeting a segment of the market—particularly those with recurrent infections—who are frustrated with the status quo and willing to pay a premium for speed, accuracy, and convenience. By integrating the UTI test with its existing vaginal microbiome analysis, prescription services, and health coaching, Evvy is building a comprehensive ecosystem designed to create long-term customer value and loyalty, justifying the subscription model.

Broader Implications and Lingering Questions

The push toward precision diagnostics for UTIs carries significant public health implications. The ability to identify resistance markers and enable targeted antibiotic use is a powerful tool for antimicrobial stewardship. By avoiding broad-spectrum antibiotics when a more targeted drug will suffice, such technologies can help preserve the effectiveness of our most critical medicines for future generations.

However, experts also raise important questions. The high sensitivity of PCR technology carries a risk of overdiagnosis by detecting low levels of bacteria that may not be clinically significant, a condition known as asymptomatic bacteriuria. This could inadvertently lead to the overtreatment of patients who don't require antibiotics, undermining some of the stewardship benefits. The medical community continues to debate the best way to integrate these powerful new tools, with some professional groups urging caution and calling for more research that demonstrates improved patient outcomes, not just improved diagnostic metrics.

Furthermore, the regulatory environment for these tests remains in flux. Most multiplex PCR panels for UTIs are offered as Laboratory-Developed Tests (LDTs), which are regulated under CLIA but do not undergo the same FDA premarket approval process as commercial test kits. As Evvy and its competitors push the boundaries of at-home diagnostics, they are navigating a landscape where technology is outpacing policy.

Evvy's launch of the UTI+ Test is a clear signal of where the market for consumer health is headed: toward greater technological sophistication, personalization, and patient empowerment. Its success will depend on its ability to convince consumers and clinicians that the benefits of speed and precision are worth the significant cost, and to prove that its high-tech solution delivers not just data, but quantifiably better health outcomes.