Harbinger Health Inc., a German-American biotech company, is partnering with Memorial Sloan Kettering Cancer Center (MSK) to accelerate the clinical validation of its innovative blood test for early-stage cancer detection. This collaboration aims to leverage MSK's expertise to enhance data collection and explore new research avenues in developing accessible and informative early cancer detection tests.
The core technology behind Harbinger Health's test is based on the discovery by founder Alexander Meissner that methylation patterns in developing placentas and various cancers share striking similarities, a phenomenon not observed in other human tissues. This insight led to the development of a highly sensitive assay, reportedly 1,000 times more sensitive than current cancer mutation liquid biopsy tests, capable of detecting minute changes in DNA methylation patterns.
The collaboration will initially focus on validating preliminary study results within the ongoing Cancer Origin Epigenetics-Harbinger Health (CORE-HH) prospective study. The goal is to design an affordable test for widespread use. Longer-term objectives include expanding validation efforts to encompass a broader range of tumor types, improving the next generation of diagnostic tests, and conducting real-world studies to support future regulatory submissions. Harbinger Health intends to pursue CLIA approval initially, followed by FDA approval.
According to Meissner, the test aims to diagnose the development of the 20 most important types of cancer before metastasis, ideally in stage I. This early detection capability could pave the way for investigating the underlying mechanisms of cancer development and potentially identifying novel therapeutic targets.
Hutan Ashrafian, Interim Chief Medical Officer of Harbinger Health, emphasized the critical role MSK will play in accelerating data collection and opening new research directions. "Together, we are working towards world-class early cancer detection that could transform the way cancer is diagnosed and managed on a societal level," Ashrafian stated.
Dr. Pike from MSK noted the compelling basis of Harbinger's test in the biology of cancer origins. "Harbinger’s test is compelling for its basis in the biology in the origins of cancer, an insight that has long been known in the cancer field but inaccessible to date as a means of detection," said Dr. Pike. "We look forward to seeing the impact this collaboration will have in the years to come."
Previously, Harbinger Health faced delays in recruiting 10,000 Americans at the Sarah Cannon Research Institute (SCRI) for a validation study (NCT05435066) of the blood test. This new partnership with MSK is part of Harbinger’s long-term strategy to build a diverse recruitment base, encompassing both ethnic diversity and a wide range of cancer types, while continuously refining, improving, and validating its technology. Harbinger Health has secured US$190m in funding to date.
