{"id":21393,"date":"2022-08-04T14:54:34","date_gmt":"2022-08-04T21:54:34","guid":{"rendered":"https:\/\/oralcancernews.org\/wp\/?p=21393"},"modified":"2022-08-04T14:54:34","modified_gmt":"2022-08-04T21:54:34","slug":"developing-a-non-invasive-test-orisdx-aims-to-offer-a-game-changer-for-detecting-oral-cancer","status":"publish","type":"post","link":"https:\/\/oralcancernews.org\/wp\/developing-a-non-invasive-test-orisdx-aims-to-offer-a-game-changer-for-detecting-oral-cancer\/","title":{"rendered":"Developing a non-invasive test, OrisDX aims to offer a \u2018game changer\u2019 for detecting oral cancer"},"content":{"rendered":"<p>Author: Melissa Fassbender<br \/>\nSource: www.news.uchicago.edu<\/p>\n<p>OrisDX has developed a novel saliva-based molecular test to detect and diagnose oral cancer earlier\u2014improving patient outcomes and saving lives.<\/p>\n<p>The Chicago-based startup was formed based on a decade of research in the field of liquid biopsy and cancer genomics at the University of Chicago and Johns Hopkins University by top physicians and scientists, including co-founders Nishant Agrawal, Chetan Bettegowda, Rifat Hasina and Evgeny Izumchenko.<\/p>\n<p>Currently, no oral cancer salivary diagnostics are endorsed by the American Dental Association. The standard for detecting head and neck cancer is a biopsy, which often occurs at late stages, and is associated with poorer patient outcomes.<\/p>\n<p>Using biomarker-based molecular genomic techniques to diagnose oral cavity cancers earlier, OrisDX\u2019s technology is based on the latest science and has been proven in clinical studies.<\/p>\n<p>\u201cThis is going to be a game changer in the field for oral cancer,\u201d said Agrawal, OrisDX CEO and section chief for otolaryngology and head and neck surgery at UChicago Medicine.<\/p>\n<p>As a surgeon and as a clinician, Agrawal treats patients with oral cancer every day and sees advanced-stage oral cavity cancer all too often, with most of his patients presenting with Stage 3 or 4 cancers.<\/p>\n<p>\u201cIt didn\u2019t make sense why most of our patients presented to us with these advanced stages,\u201d said Agrawal. His professional network includes other surgeons and head and neck oncologists who have helped confirm the team\u2019s belief that its test will be valuable to providers and patients alike.<\/p>\n<p>Improving outcomes<br \/>\nOrisDX\u2019s first product is focused on detecting oral squamous cell carcinoma (OSCC), the most common head and neck cancer impacting more than 30,000 people in the U.S. each year. The non-invasive test can detect cancer using next-generation sequencing.<\/p>\n<p>Existing tests are based on indirect tools to detect OSCC, either as light-based, brush tests, or singular biomarkers solutions. Those tools are not as reliable as the OrisDX test, which achieves \u201cthe highest sensitivity and specificity, and is the most consistent,\u201d explained co-founder Jake Stangl, MBA\u201922, chief business officer, who brings to the business more than eight years of experience in consulting for some of the largest global biopharmaceutical companies.<\/p>\n<p>Izumchenko, OrisDX chief science officer and biomedical researcher at UChicago, added that the test can improve a patient\u2019s outcome \u201con many different levels.\u201d In addition to screening patients at high risk of developing cancer, the tool enables physicians to assess patient response to treatment in real-time and adjust the course as needed.<\/p>\n<p>Additionally, head and neck cancers are known for high reoccurrence, especially during the first two years after treatment, so it is important to continue with regular testing, which the non-invasive test makes easier.<\/p>\n<p>\u201cIt\u2019s a huge help and fiscal benefit to detecting oral cancer early and not having to go through extended treatment that often involves surgery, chemotherapy and radiation, which is not only expensive but doesn\u2019t guarantee there isn\u2019t a lost life,\u201d said Hasina, chief operating officer at OrisDX, trained dentist and researcher in UChicago&#8217;s Department of Surgery.<\/p>\n<p>Early diagnosis has proven to be the most effective way to reduce cancer-related deaths, explained Bettegowda, chief medical officer and neurosurgeon at Johns Hopkins. His research was seminal in creating liquid biopsy company Thrive, which was recently sold to Exact Sciences in a deal worth up to $2.5 billion.<\/p>\n<p>\u201cWe are hopeful that OrisDx will be able to make a difference by enabling earlier detection of head and neck cancers, an area of significant unmet medical need,\u201d Bettegowda said.<\/p>\n<p>Joining forces<br \/>\nThe OrisDX team was initially formed after Agrawal and his lab performed the culminating research in 2018-2019, though several on the team have a long history of collaboration, having previously worked together at Johns Hopkins University where they published more than 20 papers in the field.<\/p>\n<p>\u201cWe found this equilibrium where we just fit well,\u201d explained Izumchenko, speaking to the development of the team. \u201cIt was only natural for us to connect\u2014this unique network of people who had been extremely successful.\u201d All of the technologies the co-founders had developed \u201cbasically joined forces,\u201d he added.<\/p>\n<p>To advance this work, the team initially connected with the University of Chicago Booth School of Business as part of the Global Social Impact Practicum, an experiential course that enables students to explore the impact of technology, social enterprise, and philanthropy on India\u2019s most pressing challenges. Five MBA students traveled to India with Hasina, visiting labs and talking with doctors to determine whether or not there was a market need for the test, and if patients would be interested.<\/p>\n<p>\u201cAt that point, what we found was that obviously there is a huge market need and interest, it would be beneficial, but the pain point was the price,\u201d explained Hasina. As the project in India was wrapping up, COVID hit, halting any progress in the region\u2014but the researchers didn\u2019t sit still and decided to pursue commercialization stateside. \u201cIt\u2019s actually better to start in the U.S.,\u201d she said, \u201cbecause we know the system and the FDA and we have the resources and ability to get it reimbursed.\u201d<\/p>\n<p>Backed by the rigor of the FDA, OrisDX would have an easier time getting buy-in from the rest of the world, said Hasina, for whom global accessibility of the test is a way to give back to her first home of Bangladesh, which has an oral cancer prevalence similar to India.<\/p>\n<p>Still, the path to commercialization is challenging. \u201cAt first it was guarded excitement because we didn\u2019t know how to do it,\u201d said Izumchenko, \u201cThe team consults companies often, but being an advisor is one thing\u2014creating something from scratch that is yours is completely different.\u201d<\/p>\n<p>\u201cIt\u2019s almost always that we conduct discovery and we do validation, but it\u2019s the biotech companies that produce the tests,\u201d added Hasina. \u201cWe knew that we had to do it; that we were the experts that know it. We couldn\u2019t just hand it to somebody else.\u201d<\/p>\n<p>Overnight entrepreneurs<br \/>\nWith a new plan in place, the next step was teaming up with a chief business officer, Stangl, who met the group through the Polsky Center\u2019s Collaboratorium, which brings together Chicago Booth students with researchers and faculty who are exploring commercialization opportunities for their work.<\/p>\n<p>\u201cWhat enticed me first about OrisDX was their team, a group of really passionate individuals who care about one thing: getting patients the help they need,\u201d Stangl said.<\/p>\n<p>OrisDX went on to participate in the I-Corps program to determine customer market fit, and the Compass deep tech accelerator, which helped guide the researchers step by step, connecting them with the right people and providing a structured path to follow.<\/p>\n<p>The startup\u2019s Polsky programming participation culminated in a first-place win and $665,000 in investment at the 26th annual Edward L. Kaplan, \u201971, New Venture Challenge, as well as a $200,000 co-investment via the George Shultz Innovation Fund.<\/p>\n<p>\u201cThe well-resourced programs at the Polsky Center really enabled and facilitated all of this. Without Polsky, we wouldn\u2019t be in this position,\u201d said Agrawal, adding that they learned a lot from many different people with different experiences, and ultimately, were able to build something from what they learned.<\/p>\n<p>\u201cIt was amazing the pace at which we went and the resources that were available to us. I became an entrepreneur overnight,\u201d added Hasina.<\/p>\n<p>Most recently, OrisDX was selected to participate in the inaugural cohort of SMILE Health, an accelerator from CareQuest Innovation Partners in partnership with MATTER focused on solutions that make oral health more accessible, equitable, and integrated with overall health.<\/p>\n<p>This combined funding will help them build out the team while formalizing regulatory and reimbursement strategies and path to market. The goal is to launch the product in Chicago across three different patient segments of screening, diagnosis and monitoring by the end of 2023.<\/p>\n<p>\u201cThere\u2019s a lot of potential for this product to really make an impact in the world,\u201d said Agrawal. \u201cWith Polsky and Booth, there are no limits. Think big, work hard, and make it happen.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Author: Melissa Fassbender Source: www.news.uchicago.edu OrisDX has developed a novel saliva-based molecular test to detect and diagnose oral cancer earlier\u2014improving patient outcomes and saving lives. The Chicago-based startup was formed based on a decade of research in the field of liquid biopsy and cancer genomics at the University of Chicago and Johns Hopkins University by top physicians and scientists, including co-founders Nishant Agrawal, Chetan Bettegowda, Rifat Hasina and Evgeny Izumchenko. Currently, no oral cancer salivary diagnostics are endorsed by the American Dental Association. The standard for detecting head and neck cancer is a biopsy, which often occurs at late stages, and is associated with poorer patient outcomes. Using biomarker-based molecular genomic techniques to diagnose oral cavity cancers earlier, OrisDX\u2019s technology is based on the latest science and has been proven in clinical studies. \u201cThis is going to be a game changer in the field for oral cancer,\u201d said Agrawal, OrisDX CEO and section chief for otolaryngology and head and neck surgery at UChicago Medicine. As a surgeon and as a clinician, Agrawal treats patients with oral cancer every day and sees advanced-stage oral cavity cancer all too often, with most of his patients presenting with Stage 3 or 4 cancers. \u201cIt didn\u2019t make sense why most of our patients presented to us with these advanced stages,\u201d said Agrawal. His professional network includes other surgeons and head and neck oncologists who have helped confirm the team\u2019s belief that its test will be valuable to providers and patients alike. Improving outcomes OrisDX\u2019s  [&#8230;]<\/p>\n","protected":false},"author":44,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[6269,6277,3415],"class_list":["post-21393","post","type-post","status-publish","format-standard","hentry","category-oral_cancer_news","tag-orisdx","tag-polsky-center","tag-saliva-test"],"_links":{"self":[{"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/posts\/21393","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/users\/44"}],"replies":[{"embeddable":true,"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/comments?post=21393"}],"version-history":[{"count":2,"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/posts\/21393\/revisions"}],"predecessor-version":[{"id":21395,"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/posts\/21393\/revisions\/21395"}],"wp:attachment":[{"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/media?parent=21393"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/categories?post=21393"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/oralcancernews.org\/wp\/wp-json\/wp\/v2\/tags?post=21393"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}