Oriana Papin-Zoghbi, CEO and co-founder of AOA spoke to Med-Tech Innovation News to discuss its offering, which includes an early-stage ovarian cancer biopsy test.
First of all, tell us about AOA and the early-stage ovarian cancer biopsy test?
AOA was co-founded by myself, Anna Jeter and Alex Fisher to make a lasting impact in the space of women’s health. Women are half of the population but diseases that disproportionately affect women receive less than 7% of funding. Our goal is to change this paradigm. We formed AOA with the aim of brining innovative, impactful and cost-effective medical technologies from research and development into the hands of the patients and providers. The three of us already have been working together for a decade in the start-up environment focussed on women’s health. We have vast experience bringing to market paradigm changing diagnostic tests globally and successfully aligning for strategic exits to drive market adoption.
The area of ovarian cancer is especially critical. 1 in 78 women will be diagnosed in her lifetime and the disease is on the rise around the world, however, there has been little to no innovation in the diagnosis since 1987. Early diagnosis of ovarian cancer is crucial, as survival of women with Stage 1 disease is more than 90%, whereas stage 4 is only around 30%. Today, most available tests aren’t sufficiently sensitive or specific to diagnose the disease early, leading to over 80% of women being diagnosed at late stages. There are also no screening methods like there are for cervical or prostate cancers.
In order to solve this major problem, we formed a collaboration with Prof Saragovi and his lab at McGill University. Prof. Saragovi is a renowned researcher with over 250 publications in the area of oncology. Prof. Saragovi’s team identified unique and promising biomarkers for the early-stage detection of ovarian cancer. In a collaboration with Prof Saragovi, our team is further developing this technology. The name of the test for early diagnosis of ovarian cancer from a blood sample is called AKRIVIS GD.
Our proof-of-concept data shows that AKRIVIS GD has both an excellent sensitivity and specificity when compared to traditional diagnostic methods.
Can you provide us some insight into the technology behind the test?
AKRIVIS GD is a simple liquid biopsy test that detects a novel class of markers that are unexploited for cancer diagnosis. Our proprietary markers, unlike other investigated markers, demonstrate important characteristics that make them ideal for a cancer diagnostic test: they originate in cancer, expressed in millions of cells per tumour, stable and non-mutating, and present throughout the cancer lifecycle and in relapse.
How does the test take place? Does it have to be done by a healthcare professional or can a patient carry it out?
Similar to currently available cancer tests, AKRIVIS GD is done by a healthcare professional. Over 90% of women with ovarian cancer experience symptoms, which leads them to seek medical attention. A blood sample will be taken by the physician and sent to the local lab for analysis. Physicians will be provided a result which will aid them in diagnosis and a referral to a specialist.
What makes this diagnostic method different from those already out there?
Current methods of diagnosis fall into three categories; biomarkers, imaging, and clinical assessment. A clinician will typically conduct a clinical assessment followed by imaging, usually in the form of a transvaginal ultrasound. These assessments lack the ability to detect early cancer and thus typically diagnose women already in late-stage disease. Biomarkers have been shown to improve the diagnosis but to date, current biomarkers available are not etiological to ovarian cancer, they produce false positive results in the presence of other common conditions including cysts, endometriosis, fibroids and other similar gynaecological conditions. Additionally, available markers are not expressed in vast concentrations in the early stages of cancer, thus impacting the markers’ ability to diagnose the cancer early.
Our preliminary data suggests that our markers are specific to ovarian cancer and present in high concentrations in early-stage disease and therefore maintain an excellent accuracy at all stages.
Is there scope for this test to be further developed?
Yes, first we will be pursuing regulatory approval for the test to aid in diagnosis of patients with symptoms of ovarian cancer, and the preliminary data already suggests the markers are excellent for monitoring the disease once a patient has been diagnosed. The expression levels of the markers also suggest they will be supportive of asymptomatic testing i.e. screening the general population.
Who did you have to work with to bring this idea to life?
We have partnered with Prof. Saragovi of McGill University. His initial work in cancer vaccine development has proven instrumental in identifying the proprietary markers. We also partnered with industry leading clinicians and advisors to further support with the development of the test to ensure it can aid with early-stage accurate diagnosis of ovarian cancer.
Any future plans? Or anything else you would like to add?
Ovarian cancer is the most lethal gynaecologic cancer and the fifth cause of cancer death in women due to the fact that 80% of women are diagnosed when the cancer is stage III or IV. Improving early-stage diagnosis is fundamental to improving the five-year survival rate. Recent studies have suggested that any improvements in test accuracy in the early stages can reduce the five-year mortality rate by as much as 50%. An accurate early diagnosis test could save up to 100,000 women per year.
We would also add that the woman plays an important role in improving these outcomes and if they suffer from continuous symptoms, they should be encouraged to see a doctor and request testing as soon as possible to hopefully rule out this challenging disease. Patients detected with stage I or II ovarian cancer have a more than 90% five-year survival rate.
We are a team that is incredibly passionate about Women’s Health and committed to solving the challenge of early diagnosis of ovarian cancer. Women deserve better.
