NEW YORK (360Dx) – When Mounir Koussa, CEO of Confer Health, learned that a colleague paid three times more for a pregnancy test to get the result one day sooner, his company began pursuing a new commercial path.
The firm, which last week completed a $9.5 million funding round, had been looking to develop a diagnostic test platform based on gel electrophoresis and DNA nanoswitches that had just a few potential uses.
Instead, he and his colleagues decided to investigate consumer needs to develop a platform that would enable a broad range of testing in the home.
"There were some interesting applications for the [DNA nanoswitch] technology, but we realized that it wasn't going to be as robust or as diverse as needed to build a versatile diagnostic platform," Koussa said in an interview. "We reassessed the technology landscape and began developing a proprietary in-house platform that can detect whole cells, proteins, and small molecules across blood, serum, urine, and saliva," he said. "We've progressed with that and the plan now is to build a clinical analyzer that is small, cheap, and easy enough to use in the home."
With an entirely new technology that employs antibody assays within a microfluidic analyzer, the firm is targeting the development and launch of its own pregnancy test, but the switch to a new platform also enables the future launch of separate assays for strep and prostate specific antigen, and the firm has completed proof-of-concept testing on assays for cardiac health, viral pathogens, and other conditions, Koussa said.
The firm said its microfluidic technology provides a new way of doing both competitive and sandwich immunoassays, potentially providing a way to enable use in the home of a broad number of antibody tests currently done in hospital and other labs.
The diagnostic platform is a reusable analyzer that accommodates disposable microfluidic cartridges containing all of the components of various assays, Koussa said.
The firm's first product, Confer Conceive, which it expects to launch in the second half of next year, will measure luteinizing hormones in urine and enable couples to track fertility, increase their chances of conceiving, and determine if the woman is pregnant two days earlier than the fastest tests currently on the market, he said.
Confer Health expects to release its strep test within 12 months of launching the pregnancy assay and analyzer and then release assays at a rate of six months per test thereafter.
Its objective is to overcome traditional resistance to the adoption of new technology by starting with an assay that is already familiar to home users, Koussa said. When people become familiar with use of the analyzer and platform in homes, they will be more likely to accept other types of tests, even those that normally are done in the clinic or hospital labs, Koussa said. For tests such as strep, cold, flu, other infectious diseases, and acute trauma, the firm plans to launch another product category, Confer Diagnose. It has plans to launch a third category, Confer Manage, in which its platform would enable managing chronic illness.
Although it has not yet published data on the clinical performance of its platform, the firm is preparing a paper that it expects to have published in the "next couple of months" that will describe its clinical methods and a clinical study for the detection of pregnancy hormones in urine, Koussa said. In developing its platform and assays, the firm ran clinical tests on about 150 samples for fertility, up to 200 participants for strep, and up to 35 participants for prostate specific antigen, he added.
The platform detected prostate specific antigen down to single-digit femtomolar levels, a point at which you can capture "all levels of recurrent prostate cancer," and which is far more sensitive than current tests, he said.
Further, the firm's strep test, in its most recent trial, demonstrated 100 percent sensitivity and 90 percent specificity, he noted. The US Food and Drug Administration requires that strep tests that provide results without a backup culture be at 98 percent sensitivity and 95 percent specificity, but the firm expects it can achieve those levels of performance. "That's a gap we think we can bridge and then launch the first rapid test that you can use in the home and that doesn't require a confirmatory culture," which can take a minimum of 48 hours, Koussa said.
Being able to substantially reduce the time required to receive a result will enable quickly prescribing or avoiding antibiotics, he said. A patient would diagnose the cause of a sore throat within minutes and call in a prescription without leaving the home.
Part of the challenge in developing the platform and its assays has been finding a technology that enables a diagnostic platform to be small, cheap, and easy to use, he said. However, figuring out how to drive adoption of an entirely new technology in the home can be just as challenging, he added.
As a result, he firm's go-to-market strategy is likely to be pivotal to its success, he said, adding, "That's why we are starting with fertility. There's an existing market, and people are motivated to test at home. There's a willingness and an ability to pay, and regulatory barriers are lower than they are for other tests."
Until it announced the closing of its funding round, Confer Health had been operating in stealth mode. The firm had to meet several technical and feasibility milestones prior to receiving all of the new funding, and it was able to achieve these 18 months ahead of schedule, Koussa said.
The firm will conduct further clinical studies for its fertility assay in preparation for applying to the FDA for clearance to market its platform and its assays. The firm expects to soon raise an undisclosed amount of additional funds that it would use to launch the fertility product, and it plans to include additional investors in that funding round, Koussa said.
As part of the manufacturing process for its analyzer and assays, Confer Health will injection mold and stamp a precision microfluidic platform, which enables use of cheaper parts elsewhere in the platform. That would contribute to reducing total manufacturing costs and enable the firm to potentially sell its analyzer for about $100 and tests at about $20 each, Koussa said. In the platform, the reaction of the analyte is read by a laser emitted by an inexpensive optics stack built using high-power LEDs, and the analyzer itself is a five to six-inch disc that could sit on a household counter, Koussa noted.
To encourage adoption of the fertility assay and analyzer, the firm expects to offer a subscription pricing model. One flat fee would cover the cost of the analyzer and provide a customized number of tests each month for a customer.
The Theranos effect
Confer Health's objective to eventually enable a broad range of testing in the home is similar to that of Theranos, a company that was once viewed as a Silicon Valley darling with potentially disruptive medical technology that would decentralize traditional lab-based diagnostic testing. The US Securities and Exchange Commission recently charged Theranos, its founder and CEO Elizabeth Holmes, and its former President Ramesh Balwani with fraud, saying it raised more than $700 million from investors by exaggerating the company's technology and its business and financial performance. Earlier this month, the firm laid off most of its workforce.
The Theranos experience "has very much affected Confer Health's go-to-market strategy, but only positively," Koussa said. "[Theranos has] proved that there is a need and demand for this kind of testing, which is helping us a lot." He noted that the firm also proved that new market entrants need to be rigorous in testing out its diagnostic product concepts, and that it had cleared a path for entities that are working on bringing diagnostics to consumers with scientific rigor "and the intent of building something that really works, hand-in-hand with the FDA from day one."
Koussa noted that Confer Health's first hire was a clinical and regulatory manager, and that its first written check was to an FDA consultant. Thus far, the firm has had four meetings with the FDA to ensure that the products it builds "are safe and effective."
Mary Sabatini, medical director of the Clinic for Reproductive Health and Cancer at Massachusetts General Hospital, said in a statement that the Confer Health technology has potential as a fertility diagnostic tool.
She noted that the technology enables faster feedback about early stages of pregnancy for couples trying to conceive and would be highly recommended by obstetricians. The company's technology could "add insight into the problem of early pregnancy loss by helping clinicians to differentiate pregnancies that are lost prior to implantation and those that occur after," she added.
At-home testing has been on the FDAs radar of late, and the topic has elicited some concerns from industry participants. For example, an expert panel at a recent FDA workshop noted that self-collection devices used in the home for Pap testing would need to be held to the same standards as Pap testing performed in the clinic.
Following the announcement in March this year that the FDA had given 23andMe the go-ahead to sell its genetic health risk report on three BRCA1 and BRCA2 mutations, some experts cautioned that the testing could mislead people to think they weren't at risk of disease when they were or that they might not grasp the subtleties of what testing can and cannot show.
In an opinion piece appearing in Stat News, however, 23andMe's CEO and cofounder Anne Wojcicki said, "As is the case for at-home pregnancy tests, I believe that years from now we'll look back and wonder why we questioned that individuals would be able to understand and responsibly act on carefully delivered health information."
On its current journey in developing an at-home pregnancy and other tests, Confer Health has learned about the important of including users in product design when you want to ultimately affect health and disease diagnostics. "Building really fancy science is not enough," Koussa said.