Canadian biotech startup Afynia Laboratories, a spin-out from McMaster University in Ontario, has picked up $5 million in seed funding to commercialize a blood test for endometriosis — a medical condition that can afflict people with a uterus, causing problems like chronic pelvic pain and fertility issues.
Endometriosis affects nearly 200 million people worldwide. Getting a diagnosis remains challenging, with some women reporting that it can take years — even up to a decade — of doctors trips and invasive tests before they obtain confirmation. That in turn delays treatments which might alleviate their pain or improve their chances of being able to get pregnant. Speeding up diagnosis, so treatments can happen faster, is Afynia’s mission.
Co-founder Dr. Lauren Foster (pictured above left) explains that endometriosis is not a single medical issue, but rather a syndrome or series of different disorders that can present with similar symptoms. Prior to doing the startup, Foster was a professor at McMaster for over two decades after an early career as a research scientist.
The startup’s approach to detecting endometriosis responds to this complexity by looking at a range of biomarkers. Specifically, its technology is based on testing the patient’s blood for the presence of microRNA — tiny molecules which play a role in switching genes on or off.
MicroRNA panel
Afynia’s microRNA test, which it’s calling EndomiR, works by looking for a panel of these molecules using an algorithm to compare the expression level of microRNA that’s circulating in the patient’s blood to people with surgically confirmed endometriosis to arrive at a diagnosis.
“We recognized that we needed to go beyond just a single biomarker and look at a panel — a panel that would have more consistency and reliability to pick up endometriosis from different types and at different stages of the disease,” Foster told TechCrunch.
“The biomarkers that we are looking at cover different aspects of the disease. So they might be involved in new blood vessel growth, they’re involved in inflammation, they’re involved in new nerve growth factor, or new peripheral nerve growth that’s related to pain — and so by targeting these different parts of the disease, they work better together in combination than any one does on its own.”
“We use markers that are reflective of these different physiological functions of the disease, but we put them together in a single panel, and we use our an algorithm in order to determine whether or not they represent a risk for disease or not,” Foster adds.
She argues that a microRNA-based test is a better way to do this than other approaches — such as trying to detect endometriosis by testing for proteins — as the traces are more stable.
A microRNA approach has also allowed the startup to find “the combination of markers that seem to work well together” for picking up endometriosis, per Foster, and supported understanding “what the confounding or interfering factors are.”
“Some of our competitors — it appears that they do not appreciate that,” she suggests.
Out of academia
While Afynia (previously called AIMA) was founded back in November 2021, Foster says the EndomiR test technology draws on the long span of her research career focused on ovarian regulation and endometriosis — which, since around 2015, included looking at microRNA, too.
Foster was previously involved in an effort to patent a protein biomarker for licensing to a pharmaceutical company in Europe. But she says the process of dealing with a commercial entity that lacked an academic grounding in the science was frustrating. Hence, along with her PhD student and now co-founder, Dr. Jocelyn Wessel (also pictured in the above feature image), they decided to take the IP they’d developed on microRNAs and form their own company with the goal of commercializing a non-invasive (in the sense of not requiring a surgical diagnosis) endometriosis test to market.
Using microRNA for the basis of disease testing is not new, nor is relying on panels of microRNA for diagnosis — and others are trying this sort of approach for picking up endometriosis, too — but Afynia believes it has an edge because it’s attacking the problem from a foundation of already having an academic discovery. (Rather than the approach that’s typical with many startups that try to develop a solution to crack a commercially valuable problem they have identified.)
“We are really the first group, I think, that found this as part of an academic lab, recognized its utility and decided to bring it to market,” says the startup’s chief medical officer, Dr. Jake Prigoff.
“It’s been a career of research, working on it and slowly moving towards microRNA,” adds Foster, describing the “ah-ha moment” that encouraged her to step out of academia into the commercial realm. She says the penny dropped after they were able to show that blinded microRNA tests on patients’ blood samples had a “very high level of agreement” with what surgeons were picking up through invasive testing.
“[Those results told us] we’ve got something here that’s interesting and worth pursuing,” she continues. “And then obviously there’s been a lot more work following that, to continue to explore, to refine, improve the reliability of the test, sensitivity.”
The startup declines to disclose any metrics on the accuracy of its EndomiR test vs. surgical diagnosis when we ask — saying it wants to keep its data under wraps until it’s finished going through Canada’s regulatory approval process for a laboratory developed test (LDT).
As part of this process it will be putting its algorithm through clinical validation to demonstrate clinical validity for the intended use-cases — focusing on diagnosis for patients with chronic pelvic pain or infertility, which are both areas it says treatments are available to manage or improve symptoms so faster diagnosis could have tangible benefits for patients.
Prigoff says the team is confident that they will be able to bring the test to market in North American later this year — they’re hopeful the LDT will be approved within the next three months.
Canada would be the first market Afynia’s test is deployed in — potentially as soon as this summer — with a launch into the U.S. slated for early next year if all goes to plan.
A better outcome for patients?
“The average patient can wait seven to eight years for a diagnosis [of endometriosis], and some of them more than a decade. And so while we can’t quantify exactly how much of a reduction we’re going to be able to bring to these patients, we’re confident that we’re gonna be able to reduce that timeline substantially,” Prigoff adds.
The need for a patient to get their blood drawn for Afynia’s test to be performed is one limit to scalability. But he suggests there’s a positive aspect here in terms of patient trust — arguing that diagnostic efforts that focus elsewhere (and don’t require needles), say such as using ultrasound and image analysis or even testing for molecule traces in saliva, can suffer from a lack of trust both among patients and the clinicians who are responsible for ordering tests.
“We feel that we have kind of the best combination of differentiating factors to be the market leader here,” he says. “The key there is patient trust and a balance between the level of invasiveness, if you will, and accuracy. Patients trust a blood test. And I think they’re a little bit skeptical of things like saliva tests, and, you know, AI-generated imaging reports. And I think clinicians are too.”
Another “differentiating factor” Prigoff claims is cost, suggesting: “We’re doing this in a way that allows us to scale beyond where I think some of our competitors’ price points will have to land — based off of the technology that they’re using.”
Further out, as the startup continues to develop its microRNA technology, Prigoff also says they’re hopeful that the test could work with just a drop of blood (i.e., from a finger prick), rather than requiring a blood draw. Although, he emphasizes that this is not possible as yet.
While endometriosis is where Afynia is putting all its energy for now, the startup wants to apply its approach to diagnosing other women’s health issues — with a plan to bring a pipeline of microRNA tests to market in the coming years. Though it remains tight-lipped on what else may be coming as Prigoff says they want to have patents filed before going public with additional tests.
Competitors also chasing the promise of non-invasive testing for female health issues include the likes of California’s NextGen Jane, which is exploring using menstrual blood collected via tampons to test for endometriosis and other health conditions; and DotLab, another U.S. player, that’s developed a blood-based test for endometriosis.
Telehealth platforms like Allara and research projects like Citizen Endo also seek to cater to endometriosis sufferers with support to manage their conditions or improve understanding of the disease.
Afynia’s seed was led by Bio-Rad Laboratories, a manufacturer of lab kit, with participation from Impact America Fund, SOSV, the Capital Angel Network, and Gaingels.
Prior to this funding round Foster says the startup had raised around $1.5 million in pre-seed funding, with backing for its earlier raise from McMaster University and some of its seed investors, including SOSV and the Capital Angel Network, plus some angel investors from New York.