NICHD RADX TECH ACT ENDO CHALLENGE AWARD - INITIAL OBLIGATION

Investigators

Abstract

Endometriosis is a chronic, debilitating condition that is associated with symptoms including chronic pelvic pain, dysmenorrhea, dyspareunia, dysuria, dyschezia, and infertility, as well as an increased risk for ovarian cancer, depression, migraines, lupus, multiple sclerosis, and other pain and autoimmune conditions. Despite the severe impact of endometriosis on quality of life, diagnosis may be delayed up to 10 years due to a normalization of intense menstrual pain by patients and healthcare providers, and the requirement for surgical visualization. This delay in prolonged patient suffering, increased risk for the development of comorbidities, and greater socioeconomic cost. Current medical and surgical treatments, which carry substantial risks and side effects, are associated with a high rate of recurrence and are best considered temporizing rather than curative. Non-invasive diagnostics and new treatments have been slow to develop, in part due to the need for better understanding of the pathogenesis and pathophysiology of the disorder. Diagnosis of endometriosis currently requires laparoscopic surgery followed by histological confirmation as the gold standard; it is driven by diagnostic biases that exist in the absence of a non-invasive diagnostic that can detect all forms and stages of endometriosis. For example, the most common form of endometriosis, superficial peritoneal endometriosis (accounting for ~80% of cases), is often only diagnosed as an incidental surgical finding or in women with the most severe symptoms who are willing and able to risk surgery to receive a diagnosis. Even among those women who receive a referral (in itself a process wrought with disparities where sex, race, and socioeconomic status can affect the perception of female pain), laparoscopic surgery is invasive, requires recovery time, and presents access barriers (e.g., geographic location of endometriosis specialists, economic costs, insurance coverage) for many patients. It also does not correlate with severity of symptoms and provides limited predictive value prognosis or progression of disease. These limitations mean that only the most life-affecting symptomatology is funneled to diagnostic surgery; cases with symptomatology that is masked as other conditions, normalized by patients and providers, or related to lesser-known comorbidities of endometriosis are missed. Transvaginal ultrasound or magnetic resonance imaging can be used to diagnose ovarian endometriomas and deep infiltrating endometriosis subtypes only in certain anatomic locations and at certain stages of disease; these techniques are not yet reliably sensitive and accurate enough for definitive diagnosis. Additionally, diagnostic accuracy via laparoscopic and imaging techniques is limited in providers and technicians without specialized training. Diagnostic biomarkers to date have proven non-specific or unreliable and are not advised for use by professional society diagnostic guideline, despite tests claiming accuracy. These barriers to diagnosis have lasting impacts on treatment and further research. Because a diagnosis is invasive and/or unreliable, clinicians may choose to treat without one. The suspicion of endometriosis may be treated with hormonal therapies or analgesics, with no attention paid to potential differences in endometriosis staging, subtype, size, location, or confounding comorbidities. Further, the diagnostic delay combined with biases of diagnosing only cases with the most severe symptoms means that even research trials must rely on cases heavily skewed towards advanced disease in white, socioeconomically advantaged populations for whom barriers to expert clinicians and specialty imaging modalities are lower. Women with African or Asian ancestry are underrepresented in diagnoses. Despite the known association with cancers, infertility, body-wide pain conditions, and autoimmune conditions, endometriosis that presents without debilitating pain is also underdiagnosed. Increased research and development are urgently required to deliver non-invasive diagnostics, improved treatments, and, ultimately, prevention and cure for endometriosis. The overall goal of the RADx Tech ACT ENDO Challenge is to accelerate the development of non-invasive diagnostic technologies that can shorten the time to diagnosis, eliminate the invasiveness of current techniques, and/or improve accessibility, safety, convenience, and costs of diagnosis. While the development of novel diagnostic modalities is encouraged in this Challenge, the application or improvement of existing advanced imaging or other techniques that can reliably, reproducibly, and sensitively help non-invasively diagnose endometriosis is also welcome. Innovators should also consider how their prototype technologies will help address disparities in the diagnosis of endometriosis among underrepresented and underserved populations. Diagnostics developed under this challenge can be directed specifically to symptomatic populations or as a screening modality for symptomatic and asymptomatic women. Source: https://www.challenge.gov/?challenge=radx-tech-act-endo