Harbinger Health Establishes RESOLVE™ as a New Category for Cancer Detection

Announces $100M financing to develop a portfolio of multi-cancer tests designed to reduce diagnostic uncertainty and delays

Financing also supports further development of the Harbinger HX platform and evidence generation for a portfolio of category-defining solutions for cancer detection

CAMBRIDGE, Mass., April 14, 2026 /PRNewswire/ -- Harbinger Health, a biotechnology company pioneering cancer resolution, today announced RESOLVE™, a new category of blood-based multi-cancer detection tests designed to bring clarity to the often-uncertain period between suspicion of cancer and diagnosis, with the first products expected to be commercially available in the second half of 2026. The company's $100 million financing raised in 2025 supports the development of the initial product portfolio, the ongoing PROCARES prospective validation study, and advancement of the Harbinger HX platform. The financing was led by the company's founder, Flagship Pioneering, and included all existing investors.

Approximately 80% of all cancers are diagnosed following the presentation of symptoms that are often confounding¹. Yet, people who present with cancer symptoms wait an average of five months for a diagnosis² while mortality can increase by up to 8% for every month of delay in starting treatment³. RESOLVE™ is a new category of multi-cancer detection solutions intended to address this critical gap between presentation and diagnosis. Powered by the Harbinger HX platform, RESOLVE™ is designed to minimize false negatives that can allow early cancers to go undetected, avoid false positives that place unnecessary burden on patients and healthcare systems and provide actionable information on the cancer tissue of origin. Together, these attributes enable faster clinical decision-making when cancer is suspected.

"For most people who present with concerning symptoms, signs or findings, it takes months to get to a diagnosis, and mortality increases significantly with each month that goes by," said Ajit Singh, Ph.D., Chief Executive Officer of Harbinger Health and Flagship Pioneering CEO-Partner. "RESOLVE™ helps clinicians move more quickly and confidently from cancer suspicion to diagnosis in people who show signs of disease, even in its earliest stages. The results from our first clinical study showed that we have a real opportunity to reset the starting line to diagnosis across multiple cancers, effectively shortening the time to treatment. This infusion of additional capital supported the pivotal PROCARES study, development of multiple RESOLVE™ products and advancement of our platform towards its full potential."

PROCARES (NCT07046260) is an ongoing, prospective, multicenter, observational study aimed at validating Harbinger's RESOLVE test in patients undergoing evaluation for suspected cancer. The study is intended to establish clinical performance in resolving cancer suspicion and supporting next-step decision-making in patients with symptoms, signs or findings suggestive of one or more cancers that lack effective non-invasive diagnostics tools. The study is approaching full enrollment, with more than 88% of participants enrolled to date. PROCARES follows Harbinger's completed CORE-HH (NCT05435066) study that demonstrated clinically meaningful performance in detecting multiple cancers and strong specificity in asymptomatic individuals, supporting a low false-positive rate across multiple cancer types.

Doug Cole, M.D., Co-Founder and Board Director of Harbinger Health and Managing Partner, Flagship Pioneering, added, "We are grateful to have the continued support of our investors who share our conviction in Harbinger's platform and team to open new and distinct possibilities in blood-based cancer detection. Since its founding, Harbinger has pioneered technology and methods that seek to address the most difficult challenges in cancer detection: performance, clinical utility and access. Harbinger's progress, coupled with this latest funding and ongoing clinical evidence generation, will fuel development of products that we believe will ultimately result in earlier therapeutic interventions for millions of people touched by cancer each year."

About Harbinger Health

Harbinger Health is leading a transformation in multi-cancer detection, introducing fundamentally new approaches to resolving cancer-related uncertainty across multiple clinical contexts. The company combines advances in artificial intelligence with proprietary insights into the biology of the origins of cancer to enable fit-for-purpose strategies grounded in shared biology and a common platform - all through a low-cost blood test. Harbinger envisions a future where the path from unexplained symptoms to a clear answer is shorter and more certain, empowering clinicians to act earlier and ensuring more cancers are detected and treated before they become life-threatening. Harbinger was founded by Flagship Pioneering after three years of foundational research in its Labs unit and launched in 2020. Learn more about Harbinger by visiting Harbinger-Health.com or following us on LinkedIn.

References:

1. Sarma, E. A., Kobrin, S. C., & Thompson, M. J. (2020). A proposal to improve the early diagnosis of symptomatic cancers in the United States. Cancer Prevention Research, 13(9), 715-720.
2. Rafiq, M., et al. (2020). Missed opportunities for earlier cancer diagnosis in primary care: a national study of the diagnostic interval. British Journal of Cancer, 122(11), 1640–1650.
3. Hanna TP, King WD, Thibodeau S, et al. Mortality due to cancer treatment delay: systematic review and meta-analysis. The BMJ. 2020;371:m4087.

SOURCE Harbinger Health