Cure
Overview
These startups are developing blood tests, at-home swabs, and AI that reads routine mammograms to catch breast and gynecologic cancers earlier.
Only about 20 percent of ovarian cancers are found at an early stage, according to the American Cancer Society. Once the disease has spread, five-year survival falls to roughly 31 percent. That gap is pulling money into women's cancer detection. The breast cancer diagnostics market is projected to reach $7.28 billion by 2030, and the market for next-generation gynecological cancer diagnostics, covering ovarian, cervical, and endometrial cancers, is expected to grow from $3.01 billion in 2025 to $3.34 billion in 2026.
"We are seeing significant innovation in women's cancer detection, particularly around liquid biopsy, multi-omics, circulating tumor DNA, and other biomarkers, increasingly combined with sophisticated computational tools," Keren Leshem, CEO of ViVac Pharma, told Cure.
Clinicians see it too. Jay Luthar, MD, Instructor in Medicine at Harvard Medical School, said multi-cancer early detection tests, better liquid biopsy platforms, AI-assisted imaging, and more targeted screening tools have entered his clinical consideration in recent years. Several aim at cancers that are usually caught late.
"The pace of development in this space feels different from even five years ago," he said.
Luthar credits the moment to scientific readiness, unmet clinical need, and available capital. Ovarian cancer, he said, deserves the most attention.
"Ovarian cancer still has no reliable early detection standard, and endometrial cancer rates are rising while screening hasn't kept pace," Luthar said. "Investor attention has followed clinical urgency, and the regulatory environment for breakthrough-designated diagnostics has become more navigable."
Leshem said a strong sensitivity number or a new biomarker won't carry a company on its own. The test has to answer a practical clinical question: What do we do differently for this patient because we have this information?
"I believe the most successful companies will combine strong biology with technologies that are accessible, reproducible, and easy to integrate into existing clinical pathways," Leshem said. "They will also need to address false positives and false negatives very seriously. In cancer detection, accuracy has very real consequences for patients."
Ariel Ganz, PhD, Founder and Managing Partner of Arben Ventures, agreed. A test that beats current benchmarks still falls short, she said, if it adds false positives or leaves doubt about where a cancer originated. She sees the bigger opportunity in pairing very early, accurate screening with personalized intervention, so care starts before symptoms do.
"Whether that looks like longitudinal tracking, using AI to target highest-risk patients, or building entirely new care pathways, innovation has to bridge the gap between finding a problem and meaningfully treating it," Ganz said.
Below are seven US-headquartered biotech companies changing how women's cancers are detected.
Teal Health
Sector: At-home screening cervical cancer, HPV self-test
HQ: San Francisco, Calif. Year Founded: 2020
Key Leaders: Kara Egan, CEO & Co-Founder; Ave Thakor, MD, PhD, Co-Founder; Sarah Rose, COO
Employees: 11-50
Stage: Seed Financial Snapshot: $23 million total raised including a $10 million round closed in January 2025
Notable Investors: Emerson Collective and Forerunner Ventures; Serena Ventures; Metrodora Ventures; LabCorp; Felicis; MedTech Innovator; Chingona Ventures; Amplifyher Ventures
Key Products: Teal Wand, FDA-approved at-home vaginal self-collection device for cervical cancer screening, paired with an end-to-end telehealth service (prescription, sample review, results portal)
Recent Highlights: Teal announced in January 2026 that its at-home screening service became available in all 50 states. In May 2025, the company’s Teal Wand received FDA approval making it the first FDA-approved at-home self-collection device for cervical cancer screening in the US. The SELF-CERV pivotal study of 600+ patients showed a 95% positive percent agreement with clinician-collected samples.
Clairity
Sector: AI-based imaging/breast cancer risk prediction
HQ: Boston, Mass.
Year Founded: 2020
Key Leaders: Connie Lehman, MD, Founder & CEO; Joan Malcolm, Chief Commercial Officer
Employees: 11-50
Stage: Series B
Financial Snapshot: $43 million Series B closed November 13, 2025, following an earlier $1 million investment from the Breast Cancer Research Foundation in January 2025.
Notable Investors: ACE Global Equity and Santé Ventures; Breast Cancer Research Foundation
Key Products: Clairity Breast, an image-based prognostic AI platform that analyzes a routine screening mammogram to generate a validated five-year breast cancer risk score, without relying on age, family history, or self-reported questionnaires.
Recent Highlights: In June 2025, the FDA granted De Novo authorization to Clairity Breast. In February 2026, Beth Israel Deaconess Medical Center administered its first clinical Clairity Breast risk score, marking the beginning of clinical use of the FDA-authorized AI platform.
Mercy BioAnalytics
Sector: Liquid biopsy/molecular diagnostics for ovarian cancer and expanding to lung and multi-cancer
HQ: Waltham, Mass.
Year Founded: 2018
Key Leaders: Dawn Mattoon, PhD, Chief Executive Officer; Ellen Snow, Chief Financial Officer; Toumy Guettouche, PhD, Chief Scientific Officer; Prasanth Reddy, MD, Chief Medical Officer
Employees: 11-50
Stage: Series B
Financial Snapshot: $59 million Series B closed September 3, 2025
Notable Investors: Novalis and Sozo Ventures; Perceptive Xontogeny Venture Fund; American Cancer Society BrightEdge; iSelect Fund; Portfolia, Avestria Ventures; Mindshift Capital; Hologic; Bruker Scientific; Labcorp
Key Products: Mercy Halo, an ovarian cancer screening test that is designed to detect pre-clinical high-grade serous ovarian carcinoma in post-menopausal women
Recent Highlights: In April 2026, the company presented new data at the SGO Annual Meeting on Women's Cancer showing improved performance of its EVP-based blood test for ovarian cancer compared with CA-125 in samples collected up to three years before diagnosis.
AOA Dx
Sector: Tumor marker gangliosides and AI-enabled technology to detect ovarian cancer
HQ: Denver, Colo.
Year Founded: 2020
Origin Story: Founded by three entrepreneurs who had been working together for over 10 years within the women’s health industry.
Key Leaders: Oriana Papin-Zoghbi, Co-Founder & CEO; Alex Fisher, Co-Founder & COO; Anna Jeter, Co-Founder & Chief Regulatory Officer; Abigail McElhinny, PhD, Chief Scientific Officer
Number of Employees: ~20
Stage: Series B to Series B-III
Financial Snapshot: $36.68 million across 15 funding events, including an October 2025 Series B-II and May 2026 Series B-III
Notable Investors: Good Growth Capital; Y Combinator; RH Capital; Easton Capital; Rhia Ventures; FemHealth Ventures’ LabCorp Venture Fund
Key Products: AKRIVISGD test, a multi-omic biomarker and AI enabled technology designed to detect ovarian cancer in symptomatic women. GlycoLocate platform uses multi-omics and advanced computational biology algorithms to diagnose early-stage cancers by using a non-invasive blood test.
Recent Highlights: In January 2026, AOA Dx released the first comprehensive analysis of realized exit outcomes across women’s health over the past 25 years. In October 2025, the company announced peer-reviewed clinical evidence published in Diagnostics that found its multi-omic model achieved 94.8% sensitivity in early-stage OC and 94.4% across all stages and subtypes, a significant improvement over the current standard of care biomarker, CA-125.
PinkDx
Sector: Molecular diagnostics for endometrial and gynecologic cancer
HQ: San Francisco, Calif.
Year Founded: 2022
Key Leaders: Bonnie Anderson, Co-Founder, Chair and CEO; Giulia Kennedy, PhD, Co-Founder and Chief Scientific Officer; Timothy McMeekan, Co-Founder, Chief Business Officer, and Chief Financial Officer; Richard T. Kloos, MD, Chief Medical Officer
Employees: 11-50
Stage: Series A
Financial Snapshot: $40 million Series A in April 2025, but a second close that brought the Series A to $45 million total
Notable Investors: Catalio Capital Management; The Production Board; Mountain Group Partners; Byers Capital; Mayo Clinic; Sandbox Clinical Ventures; Blue Venture Fund; BEVC
Key Products: A whole-transcriptome sequencing and machine-learning-based diagnostic platform that uses a vaginal swab to detect endometrial cancer
Recent Highlights: In April 2026, the company published findings in the International Journal of Gynecological Cancer that showed molecular signals associated with endometrial cancer are detectable from a vaginal swab alone without the need for uterine samples.
iSono Health
Sector: Medical imaging, automated 3D breast ultrasound, AI-enabled breast imaging
HQ: Sunnyvale, Calif.
Year Founded: 2015
Key Leaders: Neda Razavi, CEO & Chairwoman; Shadi Saberi, Co-Founder & CTO
Employees: 11-50
Stage: Series A
Financial Snapshot: $14.7M raised to date, including a $3M Seed Preferred round in 2025, plus $3.7M in non-dilutive grant funding from NIH, NSF, and NCI
Notable Investors: Draper Associates and Transform VC; JSK Venture; GreenSand Equity; The Josephine Collective
Key Products: ATUSA is an FDA-cleared wearable, and automated 3D quantitative breast ultrasound platform.
Recent Highlights: In January 2026, the company announced the commercial launch of ATUSA as it opened its Series A financing round to accelerate global deployment.
Mammogen
Sector: Liquid biopsy/molecular diagnostics for breast cancer detection
HQ: Newport Beach/Aliso Viejo, Calif.
Year Founded: 2020
Key Leaders: Elizabeth Cormier-May, Chief Executive Officer; Elise Berman, MD, Chief Medical Officer
Employees: 2-10
Stage: Series A
Financial Snapshot: Up to $30M Series A financing
Notable Investors: Led by a major U.S. public pension/retirement system
Key Products: genTRU-breast, a blood-based assay using proprietary messenger RNA (mRNA) biomarkers designed to provide a clinically actionable, real-time biologic signal for breast cancer detection, with particular relevance for women with dense breast tissue.
Recent Highlights: In June 2026, Mammogen advanced genTRU-breast into a prospective clinical trial designed to expand validation of its blood-based RNA test and support a future commercialization pathway.
