A C-suite executive at a small/medium women’s health pharma company has expertise in molecular biology/genetics, precision medicine, ovarian health & aging, fertility, and menopause. This stakeholder discusses precision medicine strategies for fertility and menopausal care. They consider investment, research, demonstrated clinical utility/validity, gold standard for testing, and limited access to care to be key challenges. They rate unmet needs highest in endometriosis and precision medicine activity in the next 1-2 years highest in menstrual health and fertility. They are excited by activity from Celmatix, Luca Biologics, Clue, Flow, Kindbody, Contraline, Gameto, Fertility, Inne, and WHOOP. They are also excited by companies working on menstrual blood biomarkers and smart tampons. This stakeholder discusses the current deployment of precision medicine strategies, unmet needs, complexity of disease, and future opportunity for precision medicine in menopausal care. In the future, they expect to see the most activity in fertility, menstrual health, and digital health spaces which bring technologies into the home and allow for daily monitoring to enable future research.

A principal at a venture capital firm and a former clinician broadly specializes in women’s health. They consider investment, research, gold standard for treatment, treatments, and reimbursement key challenges in this space.They rate unmet needs highest in endometriosis, pregnancy complications, contraceptives, and menopause. Precision medicine activity in the next 1-2 years is expected to be highest in artificial conception and perinatal testing. This stakeholder discusses challenges in the public and private investment sectors. They are optimistic on new technologies in the fertility/IVF space to improve treatments/outcomes (e.g., AI, ERA) and activity in endometriosis. They are skeptical of the utility/validity of direct-to-consumer modalities and LDTs and are interested to see which companies will make it to the true clinical realm versus stay in the consumer domain. They are excited by activity from Mirvie, Eli Health, Alife, Raydiant Oximetry, NextGen Jane, Qvin, and Gals Bio. They believe investment and prioritization in the future will occur for areas with reimbursement pathways and successful companies will build out the evidence and validation necessary for reimbursement.

A C-suite executive at a small/medium women’s health biotech has expertise in endometriosis, genetics, and prenatal testing (e.g., NIPT). They consider investment, non-invasive diagnostics, a gold standard for testing, and reimbursement to be key missing pieces today. They rate unmet needs highest in endometriosis and perinatal conditions and precision medicine activity in the next 1-2 years highest in endometriosis, fertility, perinatal testing, and artificial conception. This stakeholder discusses challenges with LDT regulation and reimbursement in this space, as well as their perspective on NIPT expansion. They would like to see a biorepository for women’s health and an all-in-one screening test for fibroids, pelvic inflammatory disease, STDs, and endometriosis. They are particularly excited by activity from ZiWig, MyOme, and Organon. In the future, they expect to see endometriosis therapeutics, do not expect significant changes to the investment landscape, and believe FDA/NIH changes could affect momentum.

An OB/GYN at a southwest integrated health network specializes in chronic and complex conditions (e.g., fibroids, cysts, endometriosis, menstrual disorders, contraception, infertility, pelvic pain, and reconstructive surgery). This stakeholder discusses investment and advances in robotics in the surgery space and regulatory challenges with pelvic mesh.They consider challenges to be greatest for non-invasive diagnostics, lacking gold standard for testing/treatment, lacking reimbursement, and limited access to care. They rate unmet needs and activity for precision medicine in the next 1-2 years moderately overall across applications, but highest in both the menstrual health and contraceptive spaces. This stakeholder discusses the complexity of pelvic pain and endometriosis and the challenges and unknowns associated with fibroids. They are particularly excited by activity by eCoin and MobileODT. In the future, they expect robotics advances will play a big role in their use of precision medicine.

A board chair for a small/medium women’s health biotech company has expertise in diagnostics, gynecologic oncology, and endometriosis. This stakeholder considers research, demonstrated clinical utility/validity, (non-invasive) diagnostics, regulatory barriers, reimbursement, and limited access to care to be significant challenges in the women’s health space. They consider the highest unmet needs to be in endometriosis, pregnancy complications, fertility, and menopause and the highest precision medicine activity in the next 1-2 years to focus on endometriosis and pregnancy complications. This stakeholder noted activity from Sumitovant/Myovant, Kindbody, Proov, Mira, and Natalist. In the future, they expect several significant shifts in healthcare driven by COVID, including consumer empowerment with at-home testing, personalized medicine, wearable devices, virtual healthcare, insurance bundling, and social determinants of health.

An assistant professor and OB/GYN at a northeast academic medical center is specialized in reproductive endocrinology and infertility. This stakeholder discusses adoption of precision medicine in the fertility and IVF space, such as endometrial receptivity analysis.They consider unmet needs greatest for research, demonstrated clinical utility/validity, and treatments. They rate unmet needs highest in endometriosis, PCOS, pregnancy complications, perinatal conditions, fertility, and contraceptives and the activity for precision medicine in the next 1-2 years highest in endometriosis, pregnancy complications, and artificial conception. This stakeholder believes there is significant unmet need in assessing lifetime fertility and would like to see “precision timing” tools to screen/prognosticate infertility, ovarian failure, and rate of follicle loss. They are excited by activity by DotLab, Oviva Therapeutics, and Celmatix. In the future, this stakeholder expects growth to be driven by areas related to fertility due to the potential for out-of-pocket payments and continued investment from the private sector rather than government/NIH. They believe artificial intelligence (AI) and RNA/microRNA will be key enabling tech modalities.

A Medical Affairs consultant at a small/medium biotech company and former OB/GYN (practiced 19 years) has expertise across precision medicine, including hereditary cancers, oncology, the direct-to-consumer space, and endometriosis. Key challenges in the women’s health space are considered insufficient investment, lacking prognostic tests, no gold standards for testing and treatment, regulatory/reimbursement barriers, and limited access to care. They consider investment from the private sector to be more of a challenge compared to public funding. They believe unmet needs are highest in endometriosis, PCOS, pregnancy complications, menstrual health, and menopause, and believe precision medicine activity will be highest in endometriosis and fertility. This stakeholder is excited by activity from 3Daughters and Luna Genetics, but notes that the recent political climate post-Roe has created challenges for NIPT. They believe the increasing number of female founders and CEOs will be a driver for investment and movement in the next 1-2 years.

An OB/GYN at a southeast integrated health network has expertise in menopause, sexual health, general and high-risk obstetrics, and surgery. This stakeholder believes private investment will accelerate innovation in this space, not public NIH funding. Key unmet needs are considered research, prognostics, a gold standard for testing and treatment, and reimbursement. They believe PCOS, pregnancy complications, and perinatal conditions have the highest unmet needs today. The greatest increase in precision medicine activity in the next 1-2 years is expected in pregnancy complications, perinatal conditions, and menopause.This stakeholder is excited by activity from the Jada System, Novocuff, PeriGen, and Astellas (particularly for their menopause drug Fezolinetant). They are also excited for a potential upcoming drug for postpartum depression.

A product leader at a small/medium women’s health biotech company has a background in genomics/genetics, molecular diagnostics, and reproductive health. This stakeholder considers research and investment key unmet needs that lead to a lack of basic biological understanding of women’s health, causing downstream challenges in development of diagnostics, treatments, etc.This stakeholder believes women’s health can benefit from the advances in the prenatal diagnostics space and that success in women’s health will come from aligning incentives with pregnancy/fetal health. They consider unmet needs highest in endometriosis, pregnancy complications, perinatal conditions, contraceptives, and menopause. In the next 1-2 years, they believe perinatal testing, artificial conception, and will see the most precision medicine activity. This stakeholder is excited by activity from Adyn, HeraMED, Delfina, PreFree, Metabolomic Diagnostics, Mirzyme, MOMM Diagnostics, NX Prenatal, and Ovia Health. In the future, they believe major initiatives like the Cancer Moonshot or a specific NIH department from women’s health separate from children could drive growth.

A marketing lead at a large global biotech company has expertise in pregnancy conditions and molecular diagnostics, but also discusses infertility and chronic conditions (e.g., endometriosis, PCOS). They primarily see precision medicine in this space through a molecular diagnostic lens but acknowledge that digital health tools could be used to potentially screen patients in the future. Research and investment are considered key challenges, including a lack of sample availability tied to clinical and various “omic” data in women’s health and a lack of NIH funding. This stakeholder believes these are upstream bottlenecks causing other challenges in this space, such as (non-invasive) diagnostics and treatments. Unmet needs are considered highest in endometriosis, perinatal conditions, and menopause, and next highest in PCOS, pregnancy complications, and contraceptives. They believe endometriosis and artificial conception will see the highest precision medicine activity in the next 1-2 years. This stakeholder is excited by activity from Mirvie, Hera Biotech, NextGen Jane, Adyn, and Dama Health. A winning solution for this stakeholder is a differential diagnostic panel for pelvic pain.

A medical oncologist at a Northeast Academic NCI Comprehensive Cancer Center discusses their utilization and understanding of MRD and ctDNA monitoring in patients with bladder, renal, and prostate cancers. Currently, they are most familiar with these technologies in bladder, and are most optimistic about post-surgical MRD as compared to ctDNA monitoring due to lack of data in the latter. They are most familiar with Natera for MRD testing, though they are open to changing vendors in the future based on who has the most promising data specific to the patient populations they treat. They have already adopted MRD as a tool to help risk-stratify patients and in cases when they are resistant to treatment suggestions, test results can help rationalize this oncologists recommendations.

A medical oncologist and internist at a Southwest Comprehensive Cancer Center discusses their use of MRD / ctDNA monitoring. They utilize these technologies most often in melanoma patients but expect there to be more uptake of these tests in other common cancers such as lung, CRC, breast, and prostate. A major hindrance to their recommendation of using these tests is around lack of clinical data and guideline inclusions, in which they imagine vendors who release reputable data the most quickly will see the most success in this market. They are most familiar with Guardant and Natera as vendors in this space and are decently satisfied with both providers. They mentioned time to market / both these companies being early movers were key to their success.

A radiation oncologist and internist at a South-Central Comprehensive Cancer Center speaks to their experiences with MRD and ctDNA monitoring. A skeptical user of these technologies, this expert has experienced false positive and negative results firsthand, inhibiting their trust in using these types of tests. They are most familiar with Signatera for MRD and monitoring, but they are open to potentially changing vendors in the future based on clinical data releases, FDA approvals, and guideline recommendations. They do not expect the market to be a winner-takes-all scenario, though they believe that there are advantages to tumor-informed tests. Though this individual does not readily use MRD or ctDNA monitoring on their patients, they are most familiar with it in CRC, and they expect that there could be increased applications in breast cancers and NSCLC as well as esophageal cancer in the future pending guideline recommendations.

A diagnostics executive at a top pharma company discusses their current explorations of MRD and ctDNA monitoring. They are most familiar with Natera and Guardant as vendors, and in the future, they expect tumor-agnostic testing will be favored for broader use. They also provided feedback on ArcherDx, C2I and Grail. While they see utility of these technologies most in CRC and lung cancers, they imagine that there is potential for use in other indications such as breast, prostate, and ovarian cancers. This stakeholder mentioned these technologies already support registrational cancer trials for both targeted and immuno-oncology therapies. They believe that clinician education will be key hurdle needed to drive adoption.

A medical oncologist at an integrated health network on the East Coast expects the health care industry to adopt both MRD and ctDNA monitoring in the near future. They currently use these technologies for NSCLC, CRC, and breast cancer, with some monitoring done for melanoma patients as well. Monitoring to inform maintenance therapy is a use case they have adopted. They imagine that other cancer types would benefit from these tests, including renal cancer, bladder cancers, and even some rare tumor types like tumors of the head and neck. They utilize Natera and Guardant and are satisfied with both vendors. They do not expect to change vendors anytime soon, and they also do not imagine that the MRD marketplace will be a “winner takes all” landscape. Customer service was cited as key vendor criteria, and care needs to be taken so test costs do not fall on patients.

A medical oncologist at a specialty cancer center discusses their current experiences with using monitoring and MRD tests for their patients. This medical oncologist is most familiar with ctDNA monitoring in NSCLC and CRC patients, as well as some patients with renal or bladder cancer. They expect their use of these technologies to increase in coming years, as they see utility in other cancer types such as breast and even pancreatic. Their current test of choice is Signatera, though they were once a Guardant user, having since found preferences for tumor-informed testing. They expect that increased payer coverage and stronger clinical utility data will expedite test implementation, as they themselves would double their test volumes if prices allowed for it.

A director in translational medicine at a large pharma company speaks about their understanding of the utility of MRD and monitoring. They favor ctDNA monitoring as having more use-cases today, assuming that the assays have high sensitivity and specificity. They work mostly with trials for lung cancer patients, but they expect that other solid tumor cancers will benefit from these technologies in the future, especially if approaches are tumor informed. A strong user of Natera and Foundation Medicine, this stakeholder does not expect to switch vendors in the near future. They hope to see more coverage of these technologies in coming years to help with wider adoptions of testing and note that high prices are a barrier to uptake.

A solid tumor diagnostics lead at a multinational pharmaceutical company discusses their opinions around MRD and monitoring across different cancer indications, with their optimism for these technologies focused on CRC. This stakeholder works at a company that conducts ctDNA testing across thousands of patients in clinical trials every year, and is familiar with the MRD offerings from vendors such as Foundation Medicine, Natera, Guardant, Personalis, NeoGenomics, Invitae, Inivita, and Grail. This stakeholder dives deeply into the pain points around sequencing tumors, outlines future trends around using WGS and methylation sequencing, and expresses a sentiment that the MRD/monitoring market will eventually be dominated by 1-2 key players.

A community hospital oncologist speaks about their current usage of MRD and monitoring technologies. Though they currently use these technologies in the NSCLC setting along with complementary technologies like imaging, they have very optimistic perspectives of the use of these technologies for breast cancer, CRC, prostate, and renal cancers in the future. While reimbursement and coverage may be considered a pain point in the adoption of more advanced testing, this stakeholder notes that payers are fairly cooperative with covering tests that occur <2x a year from their current vendors. This oncologist is familiar with multiple vendors but primarily uses Caris, and they expect the MRD and monitoring landscape to have opportunities for multiple players to succeed. They have already started exploring post adjuvant concordance with post-adjuvant PET scans as a form of internal validation.

A director of translational oncology at a major global pharmaceutical company is familiar with MRD and monitoring for a variety of cancer applications, but is more optimistic about the utility of longitudinal monitoring compared to MRD. In addition to utility of this technology in lung, breast, CRC, bladder, and melanoma, this stakeholder expects renal cancer patients to benefit in the future as well. They are familiar with a variety of competitors in the space including Guardant, Natera, Invitae, and Foundation Medicine, though they expect the market to be dominated by only a few major players in upcoming years. These tools already play a key role in solid tumor clinical trials, but highlights cost limits the scale of experiments today, especially for serial testing.

A medical oncologist at a Southwestern AMC speaks about MRD and monitoring usage and trends for melanoma, breast cancer, colorectal cancer, bladder cancer, and lung cancer. Additionally, they speak to implementation of MRD for hepatocellular cancers. This stakeholder is most familiar with Guardant and Natera tests for MRD. They have an optimistic expectation for the adoption of MRD, specifically for CRC applications, and for monitoring in NSCLC and CRC populations, with the caveat that guidelines will be crucial to widespread adoption across the testing paradigm for all cancer types. Speaking to the landscape of competitors, this stakeholder values customer support and EMR integration, and envisions that the future of MRD and monitoring test selection will be dictated by patient’s preferences in addition to the physician’s vendor knowledge.