Spin-out from McMaster University in Ontario, Canadian biotech startup Afynia Laboratories has won $5 million in seed funding to commercialize blood tests for endometriosis. Infertility issues.
Endometriosis affects nearly 200 million people worldwide. Getting a diagnosis remains challenging, with some women reporting that it can take years from a doctor's trip or an invasive test before getting confirmation. It delays treatments that may reduce their pain or increase their chances of becoming pregnant. Affinia's mission is because treatment can occur faster to speed up the diagnosis.
Co-founder Dr. Lauren Foster (pictured at the top left) explained that endometriosis is not a single medical problem, but a syndrome or a set of different disorders that can present similar symptoms. Masu. Before starting a startup, Foster was McMaster's professor for over 20 years after his early career as a research scientist.
Startup approaches to detect endometriosis respond to this complexity by looking at a variety of biomarkers. Specifically, the technique is based on testing a patient's blood for the presence of microRNAs. This is a small molecule that plays a role in switching genes on or off.
microRNA panel
Afynia's MicroRNA Test calls Endomir, but using an algorithm to search for a panel of these molecules and surgically confirm endometriosis in endometriosis to reach a diagnosis. It works by comparing the expression levels in the patient's blood.
“We have realized that we need to look at the panel beyond a single biomarker, which is consistent and trustworthy to pick up endometriosis from different types and stages of disease. It's a sexually enhanced panel,” Foster told TechCrunch.
“The biomarkers we see cover various aspects of the disease. Therefore, they may be involved in the growth of new blood vessels, they are involved in inflammation, and new nerve growth. It is involved in the growth of new peripheral nerves associated with factors, or pain. Rather than doing it independently than anyone else, it works together together.”
“We use markers that reflect these various physiological functions of disease, but we combine them into a single panel. We use algorithms to determine whether they represent a risk of disease. I'll add “Foster.”
She argues that microRNA-based testing is a better method than other approaches, such as trying to detect endometric disease by testing proteins, as the traces are more stable. .
Also, the MicroRNA approach allowed startups to find “combinations of markers that work together” to pick up and support endometriosis, foster parents, and “what the confounding or interfering factors are.”
“Some of our competitors — they don't seem to appreciate it,” she suggests.
From the academia
Afynia (formerly known as Aima) was founded in November 2021, but Foster said it was based on a long range of research careers focusing on ovarian regulation and endometriosis. says Foster.
Foster was previously involved in efforts to patent protein biomarkers to license them to European pharmaceutical companies. But she says the process of dealing with commercial bodies that lacked the academic foundation of science was frustrating. Therefore, along with her doctoral student and now co-founder Dr. Jocelyn Wessel (also depicted in the functional image above), they acquired the IP developed with MicroRONA and commercialized it. I decided to form my own company as my goal. Non-invasive (in the sense that no surgical diagnosis is required) endometriosis tests go to the market.
Using microRONA based on disease testing is not new and does not rely on a panel of microRNAs for diagnosis. They also try this kind of approach to pick up endometriosis, but Afynia believes it has an advantage because it is attacking the problem. A foundation that has already made academic discoveries. (As not the typical approach in many startups trying to develop solutions to solve commercially valuable problems they have identified.)
“I think we are the first group to find this as part of the academic institute, recognize its usefulness and decide to bring it to the market,” says Jake, the startup's chief medical officer. Dr. Prigoff says.
“It's a career in research, and I'll work on it and move slowly towards the microluna,” Foster adds, explaining the “oh, a moment” that encouraged her to go out of academia and into the commercial realm. She was penny after a blinded microRNA test on a patient's blood sample was able to show that the surgeon had “a very high level of agreement” with what he had been taking up through invasive testing. It says it fell.
“[Those results told us] There's something interesting and worth pursuing here,” she continues. “And obviously there was more work afterwards to continue improving and improving the reliability, sensitivity of the test.”
When asked, startups refuse to disclose metrics regarding their endomeal test and surgical diagnosis accuracy. They say they want to wrap and retain the data until they complete the regulatory approval process for Canadian Institute Development Test (LDT).
Part of this process is to demonstrate the clinical validity of the intended use case through clinical verification of the algorithm. It focuses on the diagnosis of patients with chronic pelvic pain or infertility. A diagnosis of very fast symptoms can provide specific benefits for the patient.
Prigoff said the team is confident that they will be able to bring Tests to the market in North America later this year. They hope that the LDT will be approved within the next three months.
Canada will be the first market for Afynia testing to be rolled out – potentially soon this summer – with everything moving forward with plans, there will be a launch to the US scheduled for early next year.
What are the better outcomes for patients?
“The average patient can wait 7-8 years for a diagnosis [of endometriosis]and some of them have been over 10 years. So, while we cannot quantify exactly how much reductions we can bring to these patients, we are confident that we can significantly reduce that timeline,” adds Prigoff.
The need for patients to collect blood to perform Afynia testing is one limitation of scalability. However, he suggests that there is a positive aspect here regarding patient trust – diagnostic efforts (and no needle required) focusing elsewhere, the use of ultrasound and image analysis, and more Lack of trust in both patients and clinicians responsible for the order of tests, claiming that they can suffer, such as testing molecular traces in saliva.
“I feel there's the best combination of differentiators here to become a market leader,” he says. “The key there is the balance between the trust of the patient and, if you do, the level of invasiveness and accuracy. Patients trust blood tests. And they are like saliva tests. I think you're a bit skeptical of things, and I think the same goes for clinicians.”
Another “differentiator” Prigoff's claim is cost, “we do this in a way that allows us to scale beyond where some of our competitor's price ranges think we have to land. Re use.”
Furthermore, as startups continue to develop MicroRNA technology, Prigoff also hopes that the test can work with just blood (i.e. from a finger stab wound) rather than requiring a blood draw. He says that. However, he emphasizes that this is still impossible.
Endometriosis is where Afynia is currently where all the energy is located, but startups want to apply an approach to diagnosing other women's health problems. As Prigoff says he wants to file a patent before it's published in additional tests, it remains perfectly closed to what else might come.
Competitors are also chasing the promise of non-invasive testing for women's health issues. It includes things like the next Jenjane in California. This investigates using menstrual blood collected via tampons to test endometriosis and other health conditions. Another US player, dotlab, has also developed a blood-based test for endometriosis.
Telehealth platforms like Allara and research projects like Citizen Endo are urging patients with endometriosis to receive support in managing their illness and improving their understanding of the illness.
Afynia seeds are led by Bio-Rad Laboratories, the maker of lab kits, with participation from the Impact America Fund, SOSV, The Capital Angel Network and Gaingels.
Prior to this funding, Foster has raised about $1.5 million in pre-seed funds, along with some seed investors including McMaster University and SOSV and The Capital Angel Network, as well as some from New. Supporting angel investors in York.