Harbinger Health Announces Data Demonstrating Its Ability to Detect Early-Stage Multi-Cancer at the AACC Annual Scientific Meeting 2023

HarbingerHx, a biology and machine-learning-driven platform, designs tools to improve cancer care through accurate and informative screening

Three abstracts show HarbingerHx's potential to effectively and iteratively produce leading-edge cancer screening tools

CAMBRIDGE, Mass., July 26, 2023 /PRNewswire/ -- Harbinger Health ("Harbinger," "the Company"), a biotechnology company pioneering the detection of early cancer, today announced data demonstrating the development and advancement of its biology and machine-learning-driven platform, HarbingerHx. The data were presented via three poster abstracts accepted at the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Lab Expo being held in Anaheim, Calif. on July 23-27, 2023.

The abstracts validate HarbingerHx's precision and performance for early cancer detection, demonstrate the platform's potential for use in longitudinal disease monitoring, and highlight the utility of Harbinger's proprietary DNA library preparation and methodology, bolstering the Company's capability for rapid and robust innovation.

"Harbinger is pushing into new frontiers of cancer screening by pairing our proprietary insight into the biology of cancer's origins with our powerful technology platform," said Stephen M. Hahn, M.D., CEO of Harbinger Health. "We aim to turn cancer into a disease that can be managed rather than feared. The data that we are presenting at AACC point to the strength of the opportunity we have to develop an early-stage multi-cancer screening technology that is affordable, accessible and precise."

"We are building a remarkably versatile set of tools that address some of the biggest constraints in the cancer detection field today," said Tony Shuber, chief innovation officer of Harbinger Health. "These data show that we can detect a disease initiating methylation signal in cfDNA at the earliest stages of disease and at a level of extreme precision. Our tools enable us to follow this disease signal in patients with treated disease, provide data relevant to clinicians, and rapidly iterate new technologies by building sample libraries that overcome the limitations of conventional patient-derived clinical samples."

The abstracts, which are now publicly available, follow Harbinger's recently announced results demonstrating high sensitivity for early-stage multi-cancer detection at the 2023 American Society of Clinical Oncology (ASCO)'s 2023 Annual Meeting. Further details on each AACC abstract are outlined below.

Harbinger's Blood-Based Assay Demonstrates High Precision, Stability and Reproducibility on Low Tumor Content (Abstract B-361)

• Overall, the results show high technical precision and reproducibility, as well as extremely low tumor content limit of detection, validating the precision of Harbinger's assay and supporting its ability to perform early-stage multi-cancer detection, where the levels of circulating tumor DNA are low.
• Performance results are published in the 2023 ASCO Annual Meeting Proceeding.

Analytical Approach to Monitoring Disease Progression and Response to Treatment Using Molecular Profiling (Abstract B-368)

• Analytical tools were developed using the HarbingerHx platform to monitor cancer signal over time using methylation in cfDNA, a molecular biomarker, with the aim of tracking disease progression and response to treatment.
• Estimates of tumor content using methylation were highly correlated to estimates derived using whole exome sequencing, the current industry standard.
• Further, these estimates of tumor content demonstrated utility as a biomarker of disease progression when assessed against longitudinal samples of cancer patients, suggesting the ability to predict prognosis and monitor disease progression.
• Notably, in a small subset of late-stage prostate cancer patients, Harbinger's biomarkers were able to identify a patient that, despite reporting a partial response to treatment, showed sustained high tumor content, overall increase in the methylation biomarkers and ultimately succumbed to their disease, demonstrating the clinical advantage of molecular profiling for identification of disease progression.

Development of the Archived Reference Samples (AReS) Platform for Highly Efficient Product Development and Clinical Testing (Abstract B-244)

• Using genomic libraries as templates for PCR amplification, the resulting AReS libraries serve as alternate and significantly more abundant reference samples from which development, optimization, and validation studies can be iteratively performed.
• The AReS process was optimized and AReS libraries were found to be highly concordant to the original libraries across methylation metrics, binary classification score, and library composition, functionally and analytically identical to a sequencing replicate.
• The results validate the AReS platform as a novel and capital-efficient approach to expand the availability of patient-derived sample for experimentation, accelerating assay development and regulatory submissions.

About Harbinger Health
Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis and management. The company combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to identify cancer before it is visible or symptomatic with the aim of developing a low-cost, multi-cancer blood test. Harbinger envisions a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies. 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 Twitter (@harbingerhlth) and LinkedIn.

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SOURCE Harbinger Health