Singlera's PanSeer assay detects some cancers four years earlier than standard tests: study

Preliminary study data published in Nature Communications on Tuesday suggest that Singlera Genomics' PanSeer assay, a non-invasive blood test based on circulating tumour DNA methylation, can detect five types of cancer up to four years before conventional diagnosis with a single blood draw.

Chief technology officer Rui Liu, who is also a senior author on the paper, said "one unique aspect is that we use a longitudinal cohort with 10-plus years of efforts to show detection of cancer before conventional diagnosis is possible, while previous work has mostly focused on a case-control design with symptomatic cancer patients that have already been diagnosed with standard care. It is [exciting] to see that cancer signatures can be detected so early in as little as 1 mL of plasma with Singlera's PanSeer assay."

In the Taizhou Longitudinal Study, launched in 2007, more than 123,000 healthy subjects provided plasma samples for long-term storage. Participants were monitored for a 10-year period via local cancer registries and health insurance databases.

Five common cancers

The preliminary findings were based on plasma samples from 605 asymptomatic individuals, 191 whom later diagnosed with stomach, oesophageal, colorectal, lung or liver cancer within four years of blood draw. Investigators also assayed plasma samples from an additional 223 patients with cancer, plus 200 primary tumour and normal tissues. PanSeer was able to detect the five cancer types, chosen because they had high incidence rates in the Taizhou cohort, in 88% of post-diagnosis patients with a specificity of 96%. The test also detected cancer in 95% of asymptomatic individuals who were later diagnosed, but "future longitudinal studies are required to confirm this result," the authors said.

Singlera said the next phase would be to conduct a prospective cohort study and clinical trial. "However, the difficulty for prospective study is the length of time and the amount of resource involved," the company said, adding it is in the process of raising additional funds for this purpose.

Meanwhile, Singlera said it has met with the FDA twice for its blood-based colorectal cancer colonES assay and is expected to launch a trial in the "near future." The company added that it is in the "process of extending this early detection approach to additional cancer types," and is currently looking for collaboration partners in the US.

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