Afynia Secures $5M Seed Funding for Endometriosis Test

Afynia Laboratories Secures Seed Funding for Endometriosis Blood Test

Afynia Laboratories, a Canadian biotechnology company originating from McMaster University in Ontario, has successfully raised $5 million in seed funding.

This investment will be used to facilitate the commercialization of a novel blood test designed for the detection of endometriosis.

Understanding Endometriosis and Diagnostic Challenges

Endometriosis is a medical condition impacting individuals with a uterus, often leading to complications such as chronic pelvic pain and difficulties with fertility.

Globally, almost 200 million people are affected by endometriosis.

Currently, obtaining an accurate diagnosis can be a protracted process, with many patients experiencing delays of several years – sometimes even up to ten – involving numerous medical consultations and invasive procedures.

These diagnostic delays can postpone access to treatments aimed at pain relief or improved fertility outcomes.

Afynia’s primary objective is to accelerate the diagnostic timeline, enabling quicker initiation of appropriate therapies.

Afynia’s Innovative Approach to Detection

Dr. Lauren Foster, co-founder of Afynia, clarifies that endometriosis isn't a singular disease, but rather a complex syndrome encompassing various related disorders that share similar symptomatic presentations.

Before establishing the startup, Dr. Foster dedicated over twenty years as a professor at McMaster University, building upon a foundation as a research scientist.

The company’s diagnostic method addresses this complexity by analyzing a comprehensive panel of biomarkers.

Their technology centers on analyzing a patient’s blood sample for the presence of microRNA – minute molecules that regulate gene expression.

How MicroRNA Testing Works

Specifically, the test identifies microRNA, which are crucial in controlling the activation and deactivation of genes.

By examining these molecules, Afynia aims to provide a more accurate and efficient method for diagnosing endometriosis.

This approach offers the potential to significantly reduce the time to diagnosis and improve patient care.

MicroRNA Panel for Endometriosis Diagnosis

Afynia has developed a microRNA diagnostic test, named EndomiR, which functions by analyzing a specific set of these molecules. An algorithm is employed to compare the levels of microRNA found in a patient’s blood sample against those of individuals with surgically confirmed endometriosis, ultimately aiding in diagnosis.

Foster explained to TechCrunch that the necessity for a comprehensive approach was recognized. This led to the development of a panel, rather than relying on a single biomarker, to enhance both consistency and reliability in detecting endometriosis across its various types and stages.

The selected biomarkers address multiple facets of the disease. These include processes like the formation of new blood vessels, inflammatory responses, and the growth of nerve factors, particularly those linked to pain perception. Combining these markers provides a more effective diagnostic capability than any single marker alone.

“Our methodology involves utilizing markers that accurately reflect the diverse physiological functions impacted by the disease,” Foster stated. “These markers are integrated into a unified panel, and our algorithm assesses whether their combined profile indicates a disease risk.”

Foster contends that a test based on microRNA analysis offers advantages over alternative methods, such as protein detection. This is due to the increased stability of microRNA traces within the bloodstream.

The microRNA approach has also enabled the company to identify optimal marker combinations for endometriosis detection. Furthermore, it has facilitated a deeper understanding of potential factors that could interfere with accurate results.

“It seems some of our competitors haven’t fully grasped this crucial aspect,” Foster implied.

Emerging from Research

Founded in November 2021 as AIMA, now known as Afynia, the company’s EndomiR test technology is rooted in extensive research conducted by Foster, focusing on ovarian regulation and endometriosis. This research, spanning many years, incorporated the study of microRNA beginning around 2015.

Previously, Foster participated in efforts to patent a protein biomarker intended for licensing to a European pharmaceutical company. However, she found the collaboration with a commercially-focused entity lacking a strong academic background in the underlying science to be challenging. Consequently, alongside her doctoral student and current co-founder, Dr. Jocelyn Wessels, they opted to independently commercialize their developed microRNA-based intellectual property.

Their aim was to introduce a non-invasive endometriosis test – one that doesn’t necessitate surgical diagnosis – to the market. While utilizing microRNA for disease testing and employing microRNA panels for diagnosis are not novel concepts, Afynia asserts a competitive advantage. This stems from building upon a pre-existing academic discovery, rather than the typical startup approach of identifying and attempting to solve a commercially viable problem.

“We believe we are the initial group to have identified this within an academic laboratory setting, recognized its potential, and subsequently decided to bring it to market,” states Dr. Jake Prigoff, the startup’s chief medical officer.

Foster elaborates, describing a pivotal moment that prompted her transition from academia to the commercial sector. She explains that the realization came after demonstrating a “very high level of agreement” between blinded microRNA tests performed on patient blood samples and the findings of surgeons using invasive diagnostic methods.

“These findings indicated we had a promising concept worthy of further investigation,” she continues. “Subsequent efforts have focused on refining the test, enhancing its reliability, and improving its sensitivity.”

The company refrains from disclosing specific accuracy metrics comparing its EndomiR test to surgical diagnoses. They cite a desire to protect their data until completion of Canada’s regulatory approval process for a laboratory developed test (LDT).

This process involves clinical validation of the algorithm to establish clinical validity for intended applications. The focus is on diagnosing patients experiencing chronic pelvic pain or infertility, conditions where treatments exist to manage or alleviate symptoms, making faster diagnosis potentially beneficial.

Prigoff expresses confidence in launching the test in North America later this year, anticipating LDT approval within the next three months.

If successful, Canada will be the initial market for Afynia’s test, potentially as early as this summer, followed by a U.S. launch planned for the beginning of next year.

Improving Patient Outcomes?

A significant delay often plagues individuals seeking a diagnosis of endometriosis. “Patients typically experience a wait of seven to eight years for diagnosis, with some facing over a decade,” explains Prigoff. “While we cannot precisely determine the extent of timeline reduction we will achieve, we are confident in substantially shortening this period.”

Currently, Afynia’s test necessitates a blood draw, which presents a challenge to widespread implementation. However, Prigoff posits that this requirement fosters greater patient confidence. He argues that diagnostic methods relying on alternative approaches – such as ultrasound, image analysis, or saliva molecule detection – may encounter skepticism from both patients and the clinicians ordering the tests.

“We believe our unique combination of features positions us to become the leading provider in this space,” he states. “Central to this is patient trust, alongside a balance between the degree of invasiveness and diagnostic accuracy. Blood tests are generally well-received by patients, whereas they may exhibit reservations towards saliva tests or AI-driven imaging analyses. Clinicians share similar perspectives.”

Prigoff further asserts that cost-effectiveness is a key advantage. He suggests, “Our approach allows for scalability beyond what competitors might achieve, given the technologies they employ.”

Looking ahead, Afynia aims to refine its microRNA technology to potentially utilize only a small blood sample – obtained via a finger prick – instead of a full blood draw. However, he clarifies that this capability is not currently available.

While endometriosis is the current focus, Afynia intends to extend its diagnostic approach to other women’s health concerns. The company plans to introduce a series of microRNA tests over the next few years, though specific details remain confidential pending patent filings.

Several companies are also pursuing non-invasive testing solutions for women’s health. These include NextGen Jane, based in California, which is investigating the use of menstrual blood collected through tampons for endometriosis and other condition detection, and DotLab, a U.S. company that has developed a blood test for endometriosis.

Furthermore, telehealth platforms such as Allara and research initiatives like Citizen Endo are dedicated to supporting individuals with endometriosis, offering condition management assistance and improved disease understanding.

Afynia’s seed funding round was spearheaded by Bio-Rad Laboratories, a laboratory kit manufacturer, with contributions from Impact America Fund, SOSV, the Capital Angel Network, and Gaingels.

Prior to this investment, Foster indicates the startup had secured approximately $1.5 million in pre-seed funding. This earlier funding came from McMaster University, several of its seed investors – including SOSV and the Capital Angel Network – and individual angel investors from New York.