NEW YORK (GenomeWeb) – Having recently changed its name and added new executives to its team, Plymouth, Michigan-based liquid biopsy firm Celsee Diagnostics is now focusing on growing its commercial operations around its circulating tumor cell enrichment products.

The firm, formerly known as DeNovo Sciences, is also making progress on a number of industry and academic collaborations, and is in the Institutional Review Board stages of a clinical trial with the ultimate goal of obtaining regulatory approval in Europe and the US to use its CTC isolation products in a clinical capacity, Grant Howes, Celsee’s new vice president of commercial operations, told GenomeWeb.

“The technology focuses around microfluidic slides that Celsee has developed,” he explained. The slides were deliberately designed to be similar to standard microscope slides, to allow customers to perform microscopy directly on the enriched CTCs, without needing to transfer them.

“It saves time, and, because every time you’re manipulating cells you’re going to lose some of them … it also gives you more accurate enumeration,” Howes said.

The core technology is filter-based and works with or without pre-fixation, with optional staining to further refine CTC purification. Whole blood is diluted and passed through the microfluidic slide, within which are more than 52,000 wells that each have an eight-micron pore.

“As the blood flows through, the leukocytes and red cells can get through the pores with no problem whatsoever, but circulating tumor cells are typically larger, and they will get trapped in the wells,” Howes explained.

The option for staining would include cytokeratin, which can be used to mark cells from the vast majority of solid tumors, Howes said. A stain for CD45 can be used “to exclude [from analysis] any residual leukocytes that might be hanging around.”

The firm offers a manual, entry-level system called the Celsee Prep 100, that uses syringe-based force to push sample and stain through. That system can process a single sample at a time, while the automated Celsee Prep 400 processes four samples in parallel.

The Celsee Analyzer, meanwhile, functions with either Prep system. It is a six-color fluorescent scanning microscope and software that can automatically provide enumeration, as well as create and store multiple images of the CTCs along with their locations within the microfluidic, Howes said.

There is also a protocol to remove the CTCs from the slide for downstream processing using PCR or sequencing.

A recent PLoS One study demonstrated the system’s utility for molecular analysis using DNA and mRNA fluorescence in-situ hybridization (FISH). That work was done in collaboration with researchers at Johns Hopkins, Northwestern, and Thomas Jefferson Universities, as well as the University of Michigan and two universities in Rome, Italy. It demonstrated the system was able to purify CTCs from blood samples of 96 metastatic breast cancer patients, as well as 27 prostate and five colorectal cancer patients.

It further showed, in a subset of samples from patients with metastatic prostate cancer, that CTC counts were significantly higher using the Celsee system versus the US Food and Drug Administration-approved CellSearch system from Veridex, although the authors acknowledge the small sample size.

“A key feature of this platform is the ability to integrate the process of sample preparation, image analysis of CTCs, and molecular characterization of the captured cells,” the researchers noted, adding that ongoing work now focuses on “recovering single cells from the microfluidic chip for PCR and next-generation sequencing analyses.”

The platforms are research-use-only, not diagnostic tests at the moment, Howes pointed out. However, Celsee is now beginning beta clinical trials and ultimately intends to seek CE-IVD and 510(k) clearance for the system.

Concurrent with its name changes last year, Celsee also brought in new executives to help propel the technology further. Howes came aboard in early January of this year. He was most recently director of marketing at Becton Dickinson’s BD Biosciences. Prior to that he spent about four years as vice president of marketing at Accuri Cytometers, which was purchased by Becton Dickinson in 2011 for $205 million. He also had a 23-year tenure at Beckman Coulter where he was ultimately director of strategic marketing.

“My background is really cell-based assays,” Howes said, adding that he’s been able to apply that as along with his previous sales and marketing experience to jumpstart Celsee’s commercial operation. “We’re getting too many requests for demonstrations for the existing team here to manage,” he added.

The company’s CEO is Kaylan Handique. He was formerly co-founder and CTO of Handylab before that firm was acquired by Becton Dickinson in 2009 and the HandyLab Jaguar system was developed into the BD Max real-time PCR molecular diagnostics system. Handique was then vice president of R&D Systems Development for BD Infectious Disease for about two years.

Celsee is currently collaborating with recent BioMérieux spinout BioTheranostics, and will be presenting jointly at the American Association for Cancer Research annual meeting in April, “showing feasibility data for the use of BioTheranostics and Celsee technologies in tandem,” Howes said. The firm has also submitted an abstract on analysis of CTCs after enrichment on its systems in collaboration with TJU, he said, and last year began a collaboration with South Texas Accelerated Research Therapeutics to perform whole-genome sequencing on circulating tumor cells.

The firm is now focused on growing its current business by developing its customer and reference base. However, “If the technology can be used by other companies, we’re interested in a collaboration — we’re actually starting a couple of collaborations fairly soon with a view to see if our products could be incorporated into other people’s products,” Howes said.