NEW YORK (GenomeWeb) – With $25 million raised recently in a Series B financing round, Cynvenio Biosystems is gearing up to expand the liquid biopsy testing it performs through its CLIA lab and push forward in commercial plans to disseminate its test platform through a recently inked distribution agreement with Thermo Fisher Scientific.
Meanwhile, the company has also taken a major step in its international expansion plans, starting with the Chinese market, by initiating a joint venture with Livzon Diagnostics, a subsidiary of one of the investors in its Series B, Livzon Pharmaceuticals.
Cynvenio CEO Andre de Fusco told GenomeWeb this week that the company initially looked to China as a resource to accelerate and expand the clinical validity and utility research supporting its platform, which combines isolation and analysis of circulating tumor cells with simultaneous analysis of both germline and somatic mutations in circulating cell-free DNA.
"We went toChina[initially] looking for clinical partnerships — hospitals with a lot of certain types of cancer patients, so that we could onward develop our [platform]. It was something we were not able to do in a manner that pleases us here in theUS, where we've done a few clinical studies [that] were very long and the accrual rate was very slow," de Fusco said.
Genomic testing inChinamust be performed in the country, and the logistics of setting up labs to perform testing were such that it made sense to Cynvenio to go the full distance and establish a joint venture with Livzon Diagnostics, de Fusco said.
"We are setting up two reference labs right away … and we are going to be developing clinical data that we are going to submit to the Chinese FDA for approval on the assays," he explained.
In theUS, meanwhile, de Fusco said that Cynvenio's new Series B funding will help to buoy a few specific areas of the company's domestic development.
First, he said, the next year should see expansion of the company's in-house CLIA testing service, called ClearID, which has grown from an initial breast cancer-specific assay to panels for colorectal cancer, prostate cancer, and soon lung cancer as well.
"There are already a lot of colorectal and prostate cancers coming through [for testing], and we are doing research on the lung side, but we don't have a lung-specific panel yet. That's coming," he explained.
Cynvenio tests a few thousand samples through its lab every year, but its business is not limited to a centralized testing model. Rather, de Fusco said, aside from providing a service to individual oncologists or small practices, the main function of the company's CLIA lab is to provide early support to institutions that hope to eventually set up the company's platform and workflow in their own laboratories.
"That really is the destination," he said. "We are not going to be a LabCorp or a Quest."
In that vein, Cynvenio announced earlier this year that it had signed a distribution agreement for Cynvenio's LiquidBiopsy microfluidic system for the extraction and isolation of circulating tumor cells.
The idea is not only to disseminate Cynvenio's CTC isolation technology, de Fusco said, but also make its entire set of technology, workflows, and reagents available to labs that want to install the lot.
"People may want to start with our CLIA lab, send a few hundred samples through us and validate their data set, and when they are happy with it, move it in house," de Fusco said. "They can buy all the platforms and reagents through Thermo Fisher."
This offering is limited to a research-use-only context, de Fusco added, but institutions could incorporate Cynvenio technology into clinical laboratory-developed tests to be offered through their own CLIA labs.
This doesn't mean Cynvenio will cease serving individual oncologists or small practices who don't want to do their own liquid biopsy testing through its CLIA lab. In fact, it announced yesterday that it has partnered with newly launched Cambridge, Massachusetts-based patient activation company Cure Forward.
That partnership will integrate Cynvenio's ClearID with Cure Forward's web-based platform for patients to share genomic test results, access comprehensive disease information, discover treatment options, and learn about available clinical trials.
Finally, de Fusco said, Cynvenio sees its recent funding as a buoy for the final data collection, analysis, and publication of a major multi-site study conducted with researchers from Emory andThomasJeffersonUniversity, in which it has sequenced hundreds of patients longitudinally comparing circulating tumor cells, ctDNA, and FFPE tissue samples.
"Companies talk about cell-free DNA only, or CTCs only," he said, "but sometimes you see things in cfDNA that are non-specific and you need the intact cell to understand more about it. Or you may see things in the germline where [a cfDNA-only approach] might report them as somatic mutations when they are not.
"It's a new area, and I think we'll have something to say about it with this study," said de Fusco. "If you get a mutation reported and it's from the cell-free compartment, you want to be sure that it is a real mutation — a somatic mutation that can be audited, not some noise, or a ghost or a germline mutation — if you are going to treat somebody, you need something more than a spurious signal."
Using its new toehold in China, the firm also eventually plans to replicate this study on a much larger scale, he added.