In this interview, we spoke with Farideh Bischoff, PhD, Chief Medical Officer – Head of Diagnostics at HeranovaTM, about their innovative non-invasive diagnostics for endometriosis. The discussion covered challenges in ensuring diagnostic accuracy, designing patient-centered clinical trials, and forming strategic partnerships. Dr. Bischoff also shared insights into regulatory complexities impacting the broader diagnostic landscape and Heranova’s vision for the future of non-invasive reproductive health diagnostics, emphasizing inclusivity and accessibility.
Moe Alsumidaie: What challenges do you face in ensuring accuracy and reliability in non-invasive diagnostics for endometriosis?
Farideh Bischoff: The diagnostic landscape for endometriosis is outdated, with a significant unmet need for women who often remain undiagnosed for as many as 10 years from the time of initial symptom presentation. Our non-invasive, blood-based test, HerResolveTM, is designed to change that paradigm. A primary challenge is educating the public and clinical community about endometriosis, including the prevalence and the overlapping symptoms with other diseases. The current gold standard for diagnosing endometriosis is exploratory laparoscopic surgery, which is invasive and does not align with many women’s health and family planning goals. Women in their reproductive years are particularly concerned about avoiding invasive procedures like surgery, which carry risks that could affect their reproductive success. Therefore, raising awareness and understanding of a new and non-invasive, blood-based solution, like HerResolve, will be crucial to our success.
Moe Alsumidaie: How does Heranova envision changing the treatment landscape for endometriosis with early diagnostic tools?
Farideh Bischoff: The ultimate goal of our HerResolve non-invasive blood test is to develop a test that all women can use to understand their risk level or disease presence, similar to HPV Pap smear testing or mammograms. We believe that HerResolve will become an important new tool for physicians to diagnose endometriosis and reserve surgery for treatment of the condition versus exploratory for diagnosis. Data suggests that about 33% of all laparoscopic surgeries performed in the US are for endometriosis and as many as 50% of those procedures do not find endometriosis, which means there is another gynecological condition present. HerResolve has the potential to change that and become a new diagnostic standard of care.
Moe Alsumidaie: What strategic partnerships has Heranova pursued to advance diagnostic and treatment advancements?
Farideh Bischoff: Heranova seeks partnerships and collaborations worldwide, not just within the US, to establish a global presence. The company is in discussions with pharmaceutical companies that are developing new therapeutic options for endometriosis, as well as large diagnostic companies that may be looking to add a new option for women’s health to their exiting diagnostic portfolio. We are also partnering with some of the top institutions across the country to continue the development work on HerResolve through our Early Access Program, and our other pipeline diagnostic products. Finally, we are particularly focused on partnering with patient advocacy groups and organizations that are helping to bring a voice to this condition – endometriosis – and raise awareness that more attention, interest and candidly – more funding – needs to be directed toward this condition including companies actively trying to develop and deliver new therapeutic solutions and new diagnostic innovations.
Moe Alsumidaie: How does Heranova ensure patient-centered and ethically sound practices in clinical trials for reproductive health?
Farideh Bischoff: Ensuring patient safety and ethical soundness begins with obtaining Internal Review Board (IRB) approval, which carefully considers and acknowledges potential patient risks and emphasizes patient safety. Women participating in these studies must understand the investigational nature of these trials. Heranova aims to identify diseases early for proper management, starting with education and visibility to gain community support. Once we have IRB approval, we work with specific sites and centers to identify the most appropriate patients for our study. Once our trials begin, we have tight controls for sample handling, data collection and reporting. All of this leads to our clinical validation, our performance outcomes, which is crucial to demonstrating that our diagnostic test works as intended, providing accurate results. Safety protocols are in place to detect any risks, such as infections, ensuring the protection of participants and the team handling the samples.
Moe Alsumidaie: How does Heranova address barriers to participation in studies, especially in underrepresented communities?
Farideh Bischoff: Heranova’s approach to inclusivity involves working with various clinical study sites, not just well-known or large facilities, to ensure broad representation. By collaborating with small and large groups, Heranova ensures that the study population is diverse and inclusive. We include many sites representing different regions in the US and globally, ensuring that the test includes all relevant patient populations. For US FDA requirements, for example, Heranova must include a representative sample of patients that is consistent with the prevalence of the condition across the country. This comprehensive approach is a major part of the clinical development of a new diagnostic , ensuring the diagnostic tool is effective across various populations.
Moe Alsumidaie: What are the primary regulatory challenges Heranova faces, and how does the company navigate these?
Farideh Bischoff: One of the most significant challenges is patient access, and finding centers of excellence for diagnosis. This bottleneck slows recruitment and study initiation. The regulatory process also can be challenging. However, we are encouraged by our recent interactions with the FDA. It is clear to us that they are interested in our HerResolve program. The FDA, I am sure you know, is planning to take a more active role in diagnostic tests. We anticipated this development which is why we opted to proactively apply for FDA clearance for our HerResolve test. By doing so, we believe our test will be one of the first, if not THE first, approved non-invasive, blood-based test for detecting endometriosis. So, in that sense, we believe we have turned a regulatory challenge into an opportunity. By navigating these regulatory complexities, Heranova strives to bring innovations to market faster, ensuring that its diagnostic tools are accessible and effective for all women.
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.
