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GATC Biotech to Offer Liquid Biopsy Research Services While Developing Dx With Partners

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NEW YORK (GenomeWeb) – Building on its experience with cell-free DNA analysis from noninvasive prenatal testing, GATC Biotech of Germany is expanding into oncology with its liquid biopsy technology.

Having offered its GATCLiquid technology through an early access program for several months, the company is launching three liquid biopsy assays as a research service this week. In parallel, the firm is working with a number of collaborators to develop the technology for diagnostic use.

"GATCLiquid is a basic cornerstone of our strategy for the next years," GATC CEO Peter Pohl told GenomeWeb.

The company first announced the availability of its cell-free circulating DNA technology in September, making it available as part of an early access program for clinical research and cancer diagnostics development.

The technology relies on methods GATC originally developed to extract and analyze circulating DNA from maternal blood for noninvasive prenatal aneuploidy testing, which it eventually commercialized through a daughter company, LifeCodexx. According to GATC COO Marcus Benz, one of the major aspects of the technology is around quality control of the extracted DNA, but the company also developed a hybridization-based exome enrichment approach for cell-free DNA.

While many aspects of blood-based circulating DNA are similar in prenatal testing and in cancer analysis, oncology presents challenges of its own, he said. For example, the concentration of circulating tumor DNA in patients differs depending on the cancer type and stage.

Starting this week, GATC is making its technology available to researchers as a commercial service through three assays that differ in sensitivity and the number and size of targets. "We see a huge demand [for services] in basic research and also in medical research to tackle and address the field of liquid biopsy," Benz said.

The Oncoexome assay offers whole-exome sequencing of circulating tumor DNA, combining hybridization-based enrichment with sequencing on an Illumina platform, and promises to detect somatic mutations down to an allele frequency of about 5 percent, depending on the gene locus.

The Oncopanel assay uses digital PCR and Illumina sequencing to analyze mutations in 50 known cancer genes, with a sensitivity of about 1 percent.

Finally, Oncotarget uses PCR to detect cancer-specific single nucleotide variants in circulating DNA down to an allele frequency of 0.1 percent.

In parallel to offering these assays under a fee-for-service model, GATC has several ongoing collaborations to develop the technology for diagnostic use. "We're quite optimistic that tests will come out, either this year or next year," Pohl said, most likely for cancer treatment monitoring or relapse detection. "Of course early detection is the Holy Grail, but there are still a lot of things to be done" for that, he said. "We don't see that as a low-hanging fruit."

Its collaborators include the German Cancer Research Center (DKFZ) and, under the European Union-funded Epigenetics for Female Personalized Cancer Care (EpiFemCare) project, University College London.

While it is not clear yet how GATC might commercialize diagnostic tests resulting from these collaborations, a likely model is through a spin-out company, Pohl said, similar to how it commercialized its NIPT through LifeCodexx.