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On-Q-ity Sees CTC Test Value for Pharma Studies, PGx Efforts

By Edward Winnick

SAN FRANCISCO (GenomeWeb News) – With initial efforts aimed at bringing its circulating tumor cell platform to drug development researchers, On-Q-ity also has its sights set on the clinic, pharmacogenomics market, and detection of additional kinds of cells.

Last week, the Waltham, Mass.-based startup announced that Laboratory Corporation of America will market its platform to researchers in the biopharma industry. The relationship, which will take advantage of LabCorp's extensive network of biopharma partners, is expected to provide the firm with a leg up in the burgeoning, but increasingly competitive, CTC testing market, On-Q-ity CEO Mara Aspinall told GenomeWeb Daily News on the sidelines of the JP Morgan Healthcare Conference.

On-Q-ity has developed a microfluidic chip system that can capture, count, and characterize circulating tumor cells in a blood sample. It also utilizes DNA repair biomarkers that can be used to predict treatment response.

While the firm is initially focused on circulating tumor cells, Aspinall said the platform is actually a "rare cell detection system," because it eventually may be applied to circulating stem cells, circulating dendritic cells, or circulating endothelial cells.

She noted that the chip is run through a dual capture system to maximize the number of CTCs found and maximize their ability to be further characterized. "Fundamentally, we are not about just counting these cells but counting and characterizing," said Aspinall.

She also said one of the unique attributes of the firm's technology is that it allows for antibody interchangeability.

There are several hundred thousand posts on the On-Q-ity chip varying in size, and each of the posts is coated with antibodies. The blood sample flows across the gradient chip and the cells are captured by affinity and size. Aspinall said that because the system is so gentle, the cells remain intact and viable, "and that is critical."

CTC enumeration is the first step in the process. Then using biomarkers and cutting-edge technologies, such as next-generation sequencing, the system would provide physicians and patients with much more information than currently is possible and provide answers to whether a therapy, including chemotherapy, is working or not, she said. In addition, Aspinall said that the technology would enable the early detection of cancer recurrence.

The four pieces of the system that are proprietary to On-Q-ity are the chip, the capture chemistry, the imaging, and the process automation software. Aspinall described the system as being "very far along" in development.

The partnership with LabCorp is intended to get the technology into the hands of researchers conducting clinical trials to help decide whether patients should or shouldn't be included in certain studies.

"Imaging still has its place" in those studies, she said. "We just think we can supplement that."

The CTC technology "gives us a window on tumor burden, tumor load, and how that is changing in a way that has not before been possible," said Aspinall. "It gives you information that will reflect the biology much more closely than anything we've had before."

She said that ultimately the CTC technology has the potential to greatly shorten the length of clinical trials, "once we can show cancer-by-cancer that this is definitive in terms of long-term outcomes. That is transformational, the idea that we can get that data months if not years earlier."

Aspinall also believes the technology will be used as a pharmacogenomic testing component in future drug filings with the US Food and Drug Administration, and eventually in the clinic as a diganostic tool. However, she declined to discuss On-Q-ity's regulatory strategy for bringing the CTC system through the FDA.

Aspinall said that in addition to the relationship with LabCorp, On-Q-ity plans to forge some relationships with other biopharma firms independently, as well as partnerships with research tool developers, such as the next-generation sequencing firms.

She said that On-Q-ity will be technology agnostic. It will look to do RNA, DNA, gene expression, and sequencing on the cells that are found, she said.

There are other firms working on bringing CTC technologies to the market, the most notable being Johnson & Johnson's Veridex, which recently announced a partnership with Massachusetts General Hospital and already has an FDA-cleared CTC assay. In addition, Advanced Cell Diagnostics and Biocept are working on their own CTC platforms.

Aspinall said, however, that there are key differentiators for On-Q-ity's technology. She cited the advanced state and unique aspects of the technology including the gradient chip that brings out dual capture, the technology affinity and size, the intact and viable cells captured, and the powerful imaging component. In addition, she said all of the development work has been done on samples that have been shipped, which is crucial for commercialization.

She declined to discuss the firm's plans for future financings. It raised $26 million in December 2009, about seven months after she joined On-Q-ity. Among the investors in that Series A round were MDV-Mohr Davidow Ventures led the financing round, which also included Bessemer Venture Partners, Physic Ventures, Atlas Venture, and Northgate Capital.

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