A startup called Confer Health wants to put a medical test lab on your bathroom counter. And a group of venture capital firms have just supplied $9.5 million to help it do that.
The question is, do you feel like you need a medical test lab on your bathroom counter, in between the electric toothbrush and the soap dispenser?
Confer’s pitch goes like this: no one likes dragging a sick kid into the pediatrician’s office to find out whether the little one has strep throat. And people dealing with diabetes, or the aftermath of a heart attack, don’t like going to a clinic for a blood draw any better. The Boston company is building a diagnostic device — target price, $100 — that will be able to perform a range of health-related tests at home. The Confer Analyzer is about the size of a stack of six salad plates. Each test will use a disposable plastic tray that you insert into a slot in the analyzer; those will sell for between $5 and $20 each.
Test results can be remotely reviewed by a doctor, who would decide what action needs to be taken — like a prescription for an antibiotic, in the case of strep. The company’s first product will help women who are trying to conceive monitor their fertility, and find out when they’re pregnant. Confer says it will be able to deliver results on a pregnancy test up to two days sooner than the best drugstore tests now on the market.
Pending the results of a clinical trial next year, Confer hopes to get clearance from the Food and Drug Administration to begin selling the device and accompanying tests before 2019 is out.
If you think that sounds quick for a company that only built its first prototype four years ago, you’re right. But Confer cofounder and chief executive Mounir Koussa also finished his PhD in neuroscience at Harvard University in under four years, and the average is six, according to David Cardozo, an associate dean for graduate studies at Harvard Medical School. “If anyone can pull this off, it’s Mounir,” Cardozo says. “He may be the most extraordinary graduate student I’ve known.”
Koussa’s entrepreneurial cred isn’t too shabby, either. Along with his cofounder, Zhi-Yang Tsun (PhD from MIT, now earning an MD at Harvard), he participated in a half-dozen mentoring and advising programs for startups. Koussa also maxed out his American Express card, rented out extra rooms in his Dorchester condo on Airbnb, and subsisted on the meal replacement beverage Soylent to help keep the company going in its early days, before the venture capital money hit Confer’s bank account.
Koussa’s PhD work laid the foundation for the company. He was using a tool called “optical tweezers” to manipulate individual molecules, as part of his research on the inner ear. He also started thinking about useful applications for the technique. One day, he went to CVS with a friend who was trying to conceive, and purchased a pregnancy test. Voila. “This was something where a better ability to identify molecules would be useful,” Koussa says, by more quickly delivering a positive or negative result. He built a rough prototype in 2014. The technology needed to be redesigned from scratch, though, in 2017, in part to improve its ability to measure pregnancy hormones like estrogen or strep from a throat culture. It uses a magnetic particle to capture “molecules of interest” in a sample, Koussa explains, and shines light on them using a light-emitting diode and a tiny manufactured particle called a “quantum dot” to analyze and count those molecules of interest, like the hormone hCG in the case of pregnancy. That generates a test result — for example, “congratulations!”
FDA clearance will be a big milestone for Confer, as will determining if insurers will reimburse customers for some of the cost of using the company’s tests. (Do you really want to pay out of pocket for a strep test, or postprostate surgery test?) “Some progressive insurers might pick up on the fact that this is much better for the consumer, and cheaper for them overall, but we are not at all counting on reimbursement,” Koussa says. He notes that most of the company’s tests will be cheaper than the copay for an office visit, and the resulting lab fees.
Boston, thanks to its research hospitals and universities, sees a lot of innovation in diagnostic tests. But venture capitalists can be reluctant to invest, says Michael Greeley of Flare Capital Partners. In part, that’s because of long development timelines and the need for a high degree of accuracy in the test results. And, he adds, “the reimbursement frameworks are very challenged.” Companies like Daktari Diagnostics of Cambridge, which was building a briefcase-sized testing device, have raised tens of millions of dollars — without making much of a dent in the market. Daktari ceased operations last April, and the former chief executive is now seeking to sell the company’s assets.
But while diagnostics can be a challenging corner of the health care world, Dan Poscover, a Newton consultant to the industry, observes that “the entire hospital and health care system is going to shift more and to remote care,” meaning outside of hospitals and doctor’s offices. “You see it with urgent care centers, and clinics at CVS and Walgreens,” he says. But Poscover also questions whether those urgent care centers and clinics might prove to be a bigger market for Confer. Having a testing device at the home “is interesting for ovulation, or strep, but how much is somebody going to pay for that? And how often do you get strep that you just can’t go to the physician or the CVS MinuteClinic?”
There’s also the shadow of Theranos. That California company overhyped its diagnostic testing technology, and skirted FDA regulations by using its technology (and technology from others) inside its own labs — a loophole that regulators may soon close. Theranos raised $700 million from investors, and its chief executive was sanctioned by the Securities and Exchange Commission last month for defrauding investors about what the company’s technology could do.
“The positive,” says Confer cofounder Joshua Forman, “is that Theranos demonstrated a clear desire in the market for better kinds of tests,” including some that the company had suggested would be done at home. “Everyone was thrilled at the notion of being able to do what they claimed they could do,” he says.
And, Forman adds, “it is clearer now that you can’t do this without going through the FDA. It’s better for consumers that people not be selling snake oil.”