Biotech Company Looking to Detect HCC Early With Liquid Biopsy Based on Microbiome

On August 4, 2021 Micronoma, a San Diego company, reported its technology picks up signs of very early cancer from disrupted microbiome (Press release, Micronoma, AUG 4, 2021, View Source [SID1234585674]).

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Many researchers and companies are chasing the dream of detecting biomarkers of solid tumors in the blood, either to guide treatment, discover the cancer at an earlier, more treatable phase, or both. Liquid biopsies, as they are called, typically depend on finding a molecular signature of the cancer or some fragment of its DNA. Some liquid biopsy products are already approved and on the market.

Micronoma, a San Diego biotech company, is taking a different approach. The company is developing a technology designed to detect disruptions in the body’s microbiome — that vast array of bacteria and other organisms that inhabit the human body — caused by cancer. Micronomoa says its microbiome-based strategy will detect cancer at an earlier stage than other liquid biopsies.

The company announced recently that it is collaborating with researchers at the University of New South Wales in Australia on an effort to adapt its approach to early detection of liver. The collaboration is getting a boost from the Australian government in the form of a $4 million grant. Micronoma had previously focused on lung cancer, and its website talks about the advantages its technology has over low-dose CT scans for lung cancer screening.

Micronoma says its technology, which uses machine learning, can examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers for the early detection of hepatocellular carcinoma (HCC), the most common type of liver cancer, Micronoma said in a news release.

"The process is designed to improve the chances of survival of HCC patients and make effective risk disease stratification possible by discovering the disease in its earliest stages," Micronoma CEO Sandrine Miller-Montgomery told Managed Healthcare Executive.

HCC has a low overall 5-year survival rate (below 20%), primarily because themajority of patients are diagnosed at a late stage of the disease, Miller-Montgomery noted. "While HCC is still very deadly at stage 1 (the five-year survival rate is 34%) detection in stage 1 would still enable saving a significant number of lives," she said.

The cost savings to the overall healthcare system when the novel liquid biopsy detection method is implemented "will be huge, because early-stage treatment is significantly cheaper and more efficient than later stage treatment," Miller-Montgomery added.

The liquid biopsy diagnostic field is developing rapidly. Earlier this year, the FDA granted a Breakthrough Device designation for Bluestar Genomic’s proprietary noninvasive pancreatic cancer detection test in patients with new-onset diabetes.

Meanwhile, using a 400ul plasma sample, Micronoma’s initial preliminary test can detect next generation sequencing (NGS) microbial signatures that are a telltale sign of HCC, even in the earliest stages of the disease, Miller-Montgomery explained.

Micronoma’s method investigates signals from microbial signatures in the blood, which come from multiple sources, including the tumor itself and other locations, such as the GI tract.

After its research with UNSW is completed, it should take around two years for the technology to be commercially available. Micronoma is first prioritizing commercialization in the U.S. "but will work hard to expand our reach internationally, with Australia being top of the list.," Miller-Montgomery said