Biomarkers are measurable signs that provide objective information about what is happening inside the body, such as: heart rate, blood pressure, and certain lab tests. AOA Dx is a Massachusetts-based company that developed a platform to diagnose early-stage cancer through molecular biomarkers in the blood called gangliosides. Gangliosides are a type of lipid existing on the membrane of cells. Two specific gangliosides, GD2 and GD3, are uniquely expressed in certain types of tumor cells. When these gangliosides leak into the bloodstream they can be picked up by AOA’s GlycoLocate™ Platform technology after a routine blood draw. AOA’s GlycoLocate™ Platform plans to utilize the assistance of artificial intelligence to identify the shed gangliosides in the blood of patients at risk for, or symptomatic of, different types of cancer. Based on preliminary literature, their technology will be able to identify the presence of cancer and the tissue of origin, hopefully aiding in the early diagnosis of various types of cancer.
AOA Dx’s first diagnostic test within their GlycoLocate™ Platform is AKRIVIS GD™, a serum blood test that can detect the presence of ovarian cancer. Ovarian cancer has the highest mortality rate of gynecological cancers, contributing to 152,000 deaths per year. Across the world, women wait an average of 31 months from the start of symptoms to diagnosis of ovarian cancer. Most existing diagnostic tests lack sensitivity and specificity in early stages of the disease, resulting in late diagnosis and thus, a higher mortality rate.
The AKRIVIS GD™ blood test detects expression of the gangliosides GD2 and GD3. A preliminary clinical study suggests significantly higher expression of GD2 and GD3 in patients affected by ovarian cancer compared to healthy donors. The study found a high rate of selectivity and specificity, even at early stages of the disease. Recent research by AOA Dx demonstrates that the AKRIVIS GD™ technology effectively identifies disease in 90% of patients with stage I and II ovarian cancer, the stages historically most challenging to diagnose. AOA Dx is currently pursuing a multi-center, prospective clinical trial to evaluate the effectiveness of their technology for diagnosis, and subsequent treatment, of ovarian cancer.
AOA Dx’s novel ganglioside technology is the first of its kind. AOA Dx holds a US patent for their methods of ovarian cancer diagnosis and is in the process of securing Intellectual Property for the use of gangliosides in liquid biopsies for early cancer detection. There is currently no other effective screening strategy to detect early-stage ovarian cancer. If verified by clinical trials, the AKRIVIS GD™ is a simple blood test that will be minimally invasive, cost-effective, accessible and effective in identifying early-stage ovarian cancer. Considering that gangliosides are expressed during early tumor development, the GlycoLocate™ Platform testing could detect cancer even in asymptomatic patients. Moreover, preliminary studies suggest different types of gangliosides may be biomarkers for other types of cancer, including: breast cancer, brain tumors, and prostate cancer. Since there is no existing screening platform utilizing gangliosides as biomarkers for cancer, AOA Dx hopes to pioneer this technology through their GlycoLocate™ Platform.
While current literature suggests that various tumors express gangliosides, further research is needed to confirm the effectiveness of using serum gangliosides to aid in diagnosis for each type of cancer. Challenges for AOA Dx include the need for multiple clinical trials and Food and Drug Administration (FDA) approval prior to product launch. The company has raised a total of $24 million to date and is in the clinical trial process for only the AKRIVIS GD™.
In October, AOA Dx company announced a recent round of $17 Million in funding with investors from RH Capital, Y Combinator, Astia Fund, Adaptive Capital Partners, Gore Range Capital, LongeVC, The Helm, VU Venture Partners, and FemHealth Ventures and Labcorp Venture Fund. Many of these companies are investing for a second time, demonstrating a belief in the success of the business. AOA Dx plans to use the funds to open a new lab in Colorado, expand the current clinical trial and further develop the GlycoLocate™ platform to be able to test for other types of cancer.
AOA Dx was co-founded by Oriana Papin-Zoghbi, Alex Fisher, and Anna Jeter. Oriana Papin-Zoghbi is the Chief Executive Officer of AOA Dx. She has experience leading early-stage startups, ensuring multiple strategic exits. Papin-Zoghbi brings experience launching products in international markets, including the establishment of nationwide HPV screening in East Africa with QIAGEN. Prior to founding AOA Dx, she also worked with multiple smaller life science companies delivering novel diagnostics in maternal fetal medicine, oncology and infectious disease. Papin-Zoghbi holds a baccalaureate degree in economics and international relations from Boston University. She was recently honored in Inc’s 2022 Top 100 Female Founders for her work on AKRIVIS GD™, and was selected for the 2023 Bloomberg New Economy Catalyst List and The Wave Summit’s Emerging Women Found in Bio Award.
AOA Dx’s novel diagnostic technology is featured in the Journal of Precision Medicine. Their initial peer reviewed study is published by Frontiers in Oncology. The company recently received the Life Science Award, the People’s Choice Award, and the Robert J. Crowley Award at The Eddie’s, a Massachusetts Innovation Network’s Innovation competition.