Three months ago Binx Health, a Boston-based biotech firm founded in 2005, started taking preorders for its flagship product, the Io, which has been in development for over a decade. It’s a deceptively simple piece of hardware—a white-and-gray box shaped like a sloped right triangle, just under a foot wide and deep and just over a foot tall, with a pink slot for a cartridge and a touch screen. But according to experts like Jeffrey Klausner, an epidemiologist at the University of California–Los Angeles, the Io and a number of similar devices in various states of development could be “a breakthrough in our efforts to prevent and control STIs.”
The World Health Organization (WHO) estimates that people worldwide contract 376 million new sexually transmitted infections (STIs) every year, including 156 million cases of trichomoniasis, 126 million cases of chlamydia, and 87 million cases of gonorrhea—diseases that can be painful in the short term and can contribute to an increased risk of infertility, among other chronic health problems, if left untreated. Rates of transmission in many nations have been on the rise for years. CDC data from 2018 suggests the number of chlamydia infections in the U.S. have doubled since the millennium, while the number of gonorrhea infections have increased by nearly 50% over the past decade.
There is likely no singular cause behind this slow-burn, silent epidemic, but stigmas around getting tested, disclosing results to partners, and seeking treatment certainly play a role. As does the difficulty many face in finding the time to visit clinics, which may be few and far between, or overburdened and underfunded, in some areas. The costs of testing and treatment also pose substantial barriers to uninsured and low-income populations. A CDC study from 2016 found that only about 12% of people age 15 to 25 got a recommended annual screening. Regular screenings are vital to controlling STIs, as these infections are asymptomatic in many people, yet transmissible. A sizable number of those who do go in for testing have to wait several days for their results to come back from the lab, then fail to come back for treatment if they test positive.
“We need new tools and strategies to combat this epidemic,” says Klausner. “We’ve lost control.”
For years, organizations like WHO have argued that one of the most important new tools needed to stem the rising tide of STIs are cheap, fast, and easy-to-use screening tests, which can be administered outside of traditional health care settings, by people with limited training or skills, yielding reliable results that allow patients to get the treatment they need almost instantly.
There are currently a number of reliable rapid point-of-care tests on the market for diseases like the flu, including the tests done at minute clinics in many neighborhood pharmacies today. Yet while early attempts at developing rapid point-of-care tests for STIs by screening bodily fluids for antibodies to diseases delivered quick results, they were not nearly as reliable enough, usually requiring a patient to visit a clinic to confirm the initial results, thus defeating the purpose.
Over the past decade, a number of biotech firms have developed devices—many of them seemingly simple boxes with insert slots for test cartridges, like Binx’s Io—that screen fluids for bacterial or viral DNA or RNA, yielding reliable results within a couple of hours. Some of these devices have been developing tests for common STIs. But according to a 2019 WHO report, many emerging point-of-care STI testing platforms are not uniformly practical. Some require extensive training to properly purify and prepare samples, need frequent calibration and maintenance, or come with huge—perhaps infeasible—price tags.
Binx’s Io hopes to overcome these limitations. A fully integrated, automated, and maintenance-free molecular testing platform, the Io lets users to drop fluid samples, either self-collected by a patient or taken by a clinician, onto a cartridge sans prep: Insert the cartridge into a slot, follow on-screen instructions, then get lab-level results within an unprecedented 30 minutes. Binx believes that’s fast enough to deliver results not just within a day, but within one doctor’s visit, allowing patients to walk out of a screening with a full diagnosis and, if needed, a treatment plan.
“You want to be able to do something in about 30 minutes,” Binx CEO Jeff Luber tells Fortune, “because the literature shows that people are willing to wait about 30 minutes” for results.
The Io got clearance for use in Europe in April 2019 for vaginal swab and male urine sample testing. In September, Binx announced that the Io had gone into the field for its first (and thus far only) real-world trial in the United Kingdom at three National Health Service Trusts (the British health care system’s term for specialized units) and in St. George’s University of London’s Applied Diagnostic Research and Evaluation Unit.
In August 2019, the FDA cleared the Io for vaginal swab tests for chlamydia and gonorrhea conducted in ob/gyn offices and certain clinics, but it has not yet been put into the field in the United States.
The Io isn’t the first FDA-approved rapid point-of-care molecular test for STIs. As of mid-2019, Cepheid’s GeneXpert system was cleared to test multiple types of samples for chlamydia, gonorrhea, and trichomoniasis. However, that platform takes 90 minutes to run a test. Cepheid did not respond to multiple requests for comment.
“Ours is the fastest FDA-cleared chlamydia-gonorrhea testing platform in history,” Luber says of Binx’s Io. “That’s a fact.”
Binx is currently seeking FDA clearance to run tests using urine samples on the Io and exploring the possibility of adding trichomoniasis screenings to its cartridges. The company, Luber says, will “be commercially launching the product [in the United States] within the second half of this year.” By year’s end, he hopes to have FDA clearance to market the Io for use in nonclinical settings as well, like urgent-care rooms and pharmacy minute clinics. That could potentially set the company up for great expansion in 2021.
Binx plans to provide clinics with free rental devices, then charge them between $60 and $90 per single-use test cartridge, which costs in the single-digits to manufacture. The company hopes that this will appeal to health care providers as it will undercut the cost of existing tests, which average about $125 but can run up to $200 each, allowing them to reap increased profits from insurance reimbursements or offer direct-paying patients savings. Reducing the need for patient follow-up and return visits would also cut down on administrative costs for doctors and on out-of-pocket expenses like co-pays for patients.
Luber claims that at least 13 health organizations have expressed interest in preordering the current Ios, even though Binx has not done much marketing. He hopes these early prospective buyers will represent up to $3.5 million in projected revenues. A Binx survey of 116 ob/gyns found that about three-fourths would be interested in adopting the Io or a similar platform.
But Binx’s greatest potential, for profitability and public health, likely lies in getting the Io into neighborhood pharmacies. Hilary Reno, director of the St. Louis County Sexual Health Clinic, notes that pharmacies are often far more accessible—conveniently located and open at all hours of the day—than most health clinics. Barbara van der Pol of the American STD Association adds that putting testing devices in pharmacies “is going to be huge in the fight against stigma, because it could be something you see everywhere,” as just another facet of everyday health. (Van der Pol also directs the University of Alabama–Birmingham’s STD diagnostics lab, which performed comparator testing on the Io.)
Combine this increased accessibility and normalizing visibility with the Io’s speed—the ability to potentially ask a minute clinic staffer to run a test for you, then go shopping or grab food nearby, and come back for definitive results and any needed prescriptions or advice—and pharmacy placement could have a huge effect on STI screening and transmission rates.
“We’re talking to a lot of retail pharmacies,” Luber says. “They’ve lost a lot of front-of-store sales in soap and paper towels and all of that to Amazon. So, they’re trying to do more things to generate revenue in health care.”
Since its founding—originally as Atlas Genetics, a spinoff of a University of Bath research project—Binx has had no issue attracting investor support, based on the promise of its tech. It started off with $1.5 million in seed funding, half of which came from the university-affiliated Bath Sulis Seedcorn Fund. Binx raised nearly $100 million through four rounds of funding from 2007 to 2017. Funders currently include Johnson & Johnson Innovation, the Novartis Venture Fund, Life Science Partners, RMI Investments, Technology Venture Partners, and BB Biotech. The company has also formed strategic investor partnerships with Consort Medical, whose subsidiary Bespark manufacturers Binx’s test cartridges, and Wondfo Biotech.
In 2018, the company rebranded as Binx Health and started selling at-home STI testing kits, which allow users to collect their own samples, send them in to central labs, then receive results online. At-home STI tests are accessible, private, and often comparable in price to or cheaper than traditional in-clinic testing. But they take several days to process and, if they detect an infection, require follow-up visits with health care providers to develop treatment plans.
David Cavanaugh, a partner at life sciences consulting firm DeciBio, tells Fortune that there is “potentially more of a white space opportunity” for a firm like Binx than there is for many other companies in the crowded rapid point-of-care testing platform landscape, given its focus on the relatively neglected field of STI testing. He also says that the Io’s speed and accessibility seem promising. Marco DeMeireles, a partner at investment firm TCG who focuses on emerging biotech opportunities, adds that there is always opportunity when the product has the potential to break down barriers for consumers who may need but currently have limited access to health services like regular STI testing.
But the Io is not a perfect device. A 2019 review of 107 rapid point-of-care molecular testing systems in various stages of development (not all of which test for STIs) shortlisted it as one of the 11 most promising platforms. However, it also noted that the Io, like many other rapid point-of-care devices, may not meet the needs of every community—like developing regions with limited electricity and climate controls.
Additionally, many clinics with limited resources, the review points out, may stay away from a device that currently tests only for two STIs, holding out for potential future systems that can test for the most common STIs, and perhaps other diseases as well, with similar levels of reliability and speed.
Reno adds that even if Io cartridges are cheaper than existing STI tests, patients without insurance are still not likely to be able to afford them. And Cavanaugh notes that recent regulatory changes are “expected to significantly decrease the reimbursement [values] of high-volume diagnostic tests,” like traditional lab tests for chlamydia and gonorrhea, in the near future. This may limit the Io’s appeal to potential buyers, or force Binx to lower its cartridge prices.
If Ios do make it into minute clinics, DeMeireles suggests that the company and investors may have to wait and see how consumers react to them—and how much paid and proactive marketing it would take to build awareness of and trust in them—before fully gauging their potential.
But no matter how profitable the Io turns out to be, the very fact that Binx and other companies are trying to bring products like this to market is heartening from a public health perspective. The spread of STIs has been one of the more worrying epidemics of the 21st century, yet thanks to all the stigmas built up around the subject, it rarely receives the attention, much less the innovation, it deserves. Every push to bring the latest in diagnostic technology, like rapid point-of-care platforms, to this field—to make testing easier to access, and to translate results into treatment—is a step toward making sex safer for all.
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