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Novel techniques and methods leverage Harbinger's proprietary biomarkers and aim to deliver low-cost and highly accurate tools for cancer screening, detection and diagnosis

CAMBRIDGE, Mass., Nov. 14, 2024 /PRNewswire/ -- Harbinger Health, a biotechnology company pioneering new technologies to fundamentally change cancer screening and detection, today announced the presentation of three abstracts showcasing multiple product innovations within its platform for blood-based early cancer detection.

Two abstracts were presented at the American Association for Cancer Research (AACR) Special Conference in Cancer Research: Liquid Biopsy: From Discovery to Clinical Implementation in San Diego, California, from November 13-16, 2024. These data demonstrate significant advances in the ability of the company's blood-based cancer detection technology to detect low levels of circulating tumor DNA (ctDNA) in early-stage disease, potentially enabling more cost-effective and broadly accessible early cancer screening.

An additional abstract will be presented at the Association for Molecular Pathology (AMP) 2024 Annual Meeting in Vancouver, British Columbia, Canada, from November 19-23, 2024. These data will highlight the capabilities of Harbinger's proprietary biomarkers to identify advanced adenomas, which are precursor lesions that confer an increased risk for colorectal cancer development.

"Taken together, these data demonstrate that Harbinger's biological, technological and methodological innovations could offer more accurate, accessible and clinically informative options for early disease detection and progression monitoring," said Tony Shuber, Chief Innovation Officer at Harbinger Health. "These product innovations complement the tremendous advances of our data science team. Holistically, with every step forward we take, we are getting closer towards our ultimate goal of creating tests that can integrate seamlessly into current and future care paradigms."

The following abstracts were presented at AACR Special Conference in Cancer Research: Liquid Biopsy: From Discovery to Clinical Implementation:

A Real-time PCR Method for the Detection of Cancer-specific Methylation Patterns in cfDNA (Poster #A014)

• Non-invasive liquid biopsies that leverage methylation as a biomarker for ctDNA need to be sensitive to detect low-level tumor-specific methylation patterns.
• Harbinger's quantitative methylation-specific PCR (qMSP) with locked nucleic acid (LNA) blockers targets contiguous CpG sites.
• The LNA blockers prevent non-specific amplification, enabling detection of low abundance hypermethylated DNA fragments down to 23 copies.
• When applied to ten pan-cancer methylation loci, the qMSP-LNA assay effectively distinguished cancer from non-cancer cfDNA with high specificity, even at low ctDNA levels.
• This cost-effective method could expand access to early cancer detection and monitoring, with high sensitivity for clinically relevant methylation signals.

A Methylation State Specific Targeted Background Depletion Technique for Enrichment of ctDNA Fraction (Poster #A035)

• Liquid biopsies are promising in cancer diagnostics, but low levels of ctDNA make detection challenging.
• Harbinger developed a novel CRISPR/Cas12a-based method depleting unmethylated CpG sites at precise locations, in non-cancerous cfDNA. The remaining DNA is enriched for methylated, ctDNA molecules.
• This method achieved an average of nine-fold increase in methylation signal down to a 0.01% fraction of methylated DNA.
• This technique improves the signal-to-noise ratio in methylation bioassays, enabling enhanced ctDNA detection in clinical settings.

Additionally, Harbinger presented the following abstract at the AMP 2024 Annual Meeting:

Detection of Precancerous Colorectal Polyps Using a Highly Sensitive Multi-Cancer Blood-Based Assay (ST088)

• Harbinger's blood-based cfDNA assay, known as HHx, demonstrated 38% sensitivity (8 out of 21) in detecting advanced adenomas at 90% specificity, including cases with and without high-grade dysplasia.
• The company's proprietary biomarkers were detectable in precancer tissue and remained detectable within the cfDNA milieu – demonstrating HHx's sensitivity to low abundance signals characteristic of precancerous lesions.
• Analysis of cfDNA tumor fraction demonstrated a progressive increase in cancer signals from non-cancer individuals (0.0186%), to advanced adenoma cases (0.0289%), and to colorectal cancer cases (ranging from 0.05% to 4.2% for stage I to stage IV, respectively).
• By identifying precancerous polyps with high specificity, Harbinger's biomarkers have been leveraged to identify clinically relevant patients with limited tumor signal. The presence of these biomarkers from precancerous lesions through advanced-stage disease speaks to their universal nature in cancer detection.
• The results validate the biology underpinning Harbinger's platform and support the potential clinical utility of this technology as a complementary screening tool that could enhance current cancer detection strategies.

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 X (@harbingerhlth) and LinkedIn.

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SOURCE Harbinger Health