A company focused on the early detection of cancer has raised $140 million in Series B funding to study its blood-based screening test.
Harbinger Health will use the funding to complete a 10,000-subject clinical trial on its blood-based multi-cancer screening test.
Developers of blood-based multi-cancer screening tests such as Illumina’s Grail use genomic sequencing and other approaches to detect signals from cell-free DNA (cfDNA) methylation, mutations and analytes including proteins.
Analysing the signals, in some cases using machine learning, may identify cancers early and enable patients to receive treatment while their chances of long-term survival are high.
Flagship Pioneering, the venture capital fund that created Moderna, launched Harbinger in 2020 believing that it has a better approach to multi-cancer early detection.
Due to launch in 2025, the model combines artificial intelligence and insights into an epigenetic-based biological program that is shared by most cancers.
Harbinger’s analysis focuses on patients with the earliest stage cancers. Physicians have effective ways of treating many tumours identified at those early stages but lack the means to diagnose cancers before they progress.
Initial findings so far
Earlier this year, Harbinger found its test has 82 per cent overall sensitivity of cancer detection at 95 per cent specificity in a study of 1,046 subjects.
Most, 621, of the subjects had newly diagnosed, treatment-naive cancer. The other participants had no history, diagnosis or cancer symptoms. Sensitivity for stage one cancers, the earliest type, was 74 per cent. Stage two sensitivity was 84 per cent.
Differences between studies mean cross-trial comparisons can be unreliable, but the results suggest the Harbinger test may be competitive.
Grail used a higher, 99.5 per cent specificity in a key study, minimising false positives and making comparison to Harbinger challenging, but published results at 95 per cent specificity early in development. At 95 per cent specificity, Grail’s sensitivity for stage one to three cancers ranged from 56 per cent to 90 per cent.
Harbinger is running its 10,000-subject Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study to show its test can address the unmet screening need.
CORE-HH has an estimated primary completion date of December 2023, according to ClinicalTrials.gov, with full completion scheduled for July 2025.
