Alabama startup Circulogene Theranostics just launched a new liquid biopsy test for about 10 types of cancer – based on a single drop of blood. It’s meant to serve as a patient-monitoring tool for those undergoing chemotherapy and other cancer treatments.
The diagnostic evaluates cell-free DNA that’s shed by tumor cells and circulates in the bloodstream – a tool that’s coveted by the broader precision medicine community, should it prove effective. The company’s raised about $1.23 million to date, according to a regulatory filing.
Claims to conduct diagnostics with a single drop of blood, or via liquid biopsy, have landed companies like Theranos and Pathway Genomics in trouble with the broader public. Such minimally invasive tests have drawn enormous attention from the broader healthcare community, thanks to their clear utility.
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In the case of Theranos, a damning series of Wall Street Journal pieces have called into question the mega-startup’s testing acuity and ethics – and has run into trouble with regulators along the way. And Pathway Genomics received a warning letter from the Food and Drug Administration over its liquid biopsy test for cancer, largely because it appeared to be marketed direct-to-consumer.
Circulogene cites clinical research that demonstrates its proprietary method can collect more than 100 times more cfDNA with just 1/10 of the blood compared to the current industry standard, it said in a statement. Circulogene’s proprietary technology is capable of detecting nearly 3000 cancer mutations on 50 well-established cancer-associated genes for its 10 cancer profiles, it said.
Theranostics companies are emerging quietly on the landscape, however – such as a new startup called SalveoDx that is backed by San Diego’s Edico Genome. There’s a clear market demand for such testing – but it’s still a matter of finding the technology that can clear the regulatory hurdles with ease.
“Our science team is pioneering the next generation of liquid biopsy cancer management: tumor monitoring from droplet volumes of blood. No one else is doing that,” Circulogene CSO Chen-Hsiung Yeh said in a statement. “Our proprietary DNA enrichment method results in near-full recovery of cfDNA with just 20 to 50 microliters of blood. No venipuncture is required, and when combined with next-generation genomic sequencing, we have an unprecedented laboratory diagnostic test platform for improving cancer management.”
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