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OncoCyte Plans to Commercialize LDTs Using NanoString nCounter Platform


NEW YORK (GenomeWeb) – Cancer testing firm OncoCyte has announced its intention to commercialize its liquid biopsies using NanoString Technologies' nCounter platform.

The Alameda, California-based firm recently reported promising results from a study conducted on a lung cancer diagnostic test being developed in partnership with The Wistar Institue. The study showed that the assay, which was originally developed using microarray technology from Illumina, could successfully be transitioned to the NanoString nCounter platform.

OncoCyte CEO Bill Annett told GenomeWeb that OncoCyte would look to develop future assays using nCounter technology.

"The reason for moving to NanoString is twofold," he said. "Scientifically, I think it gives good results, if not better results on samples compared to the previous generation of technology." He added that nCounter required fewer sample preparation steps, and the firm was able to operate more efficiently using it.

NanoString and OncoCyte have not officially announced an agreement, and OncoCyte officials said the assay was still in development and there was no time frame for releasing more details. But Annett said his company already has two nCounter Flex systems and could buy another as it begins to build a laboratory and seek CLIA certification.

"We looked at a number of different platforms," Annett said. "We considered staying on Illumina, that's certainly an option." Despite having good alternatives, he said the R&D team felt NanoString would be the best choice.

The study of 620 subjects reported last week replicates a previous study that was carried out at Wistar, showing that a liquid biopsy test for lung cancer could be performed using the nCounter platform rather than Illumina microarrays. As GenomeWeb reported, OncoCyte and Wistar initially teamed up in 2013 to build a gene expression classifier for lung cancer. 

OncoCyte must now independently validate the results from the most recent Wistar study in its own follow-up study, examining samples that it collects and analyzes independently using its own facility and equipment.

"The second study was Wistar replicating a Wistar study," Annett explained. "The third study will be OncoCyte doing a study on an OncoCyte machine."

Annett said OncoCyte will attempt to finalize both the assay and the algorithm that interprets test results. If successful, the firm will initiate an internal analytical validation study, a process to confirm whether the test results can be reproduced in its laboratory.

OncoCyte expects the validation study to begin in the third quarter of 2016 and will be completed during the fourth quarter. If successful the firm will kick off its commercialization plans, including hiring a sales force, building a commercial infrastructure, landing CLIA certification, and ultimately launching its lung cancer diagnostic test in the first half of 2017.

The test will be a laboratory-developed test, Annett said, as will future tests developed for the nCounter platform. In addition to the lung cancer diagnostic, OncoCyte a year ago reported positive results from human clinical studies using its PanC-Dx cancer diagnostic to detect bladder cancer and breast cancer.