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UCSD Spinout Diagnologix Using Recent NIH Grants to Develop Microbubble Tech for CTC Isolation

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NEW YORK (GenomeWeb) — Diagnologix, a year-old startup developing microbubble-based sample prep technology, has been awarded a $25,000 grant as part of the company's acceptance into I-Corps, a recently established business-development program from the National Institutes of Health and National Science Foundation.

The new grant builds on a $143,649 Phase I Small Business Innovation Research grant awarded to the company last September by the National Cancer Institute. Both awards will support the development of Diagnologix's microbubble technology as a platform for isolating rare circulating tumor cells from patient blood samples for downstream molecular analysis.

Michael Benchimol, principal investigator at Diagnologix and PI on the NIH grants, told PCR Insider in an email this week that the company last year spun out of research conducted in the laboratories of Dmitri Simberg and Yu-Tsueng Liu at the University of California, San Diego Moores Cancer Center.

The company's core technology, called buoyancy-enabled separation, was described in two separate papers published by UCSD-affiliated company founders and other researchers in March 2013 in PLOS One and in December 2013 in Methods. The technique consists of using perfluorocarbon gas-filled immuno-tagged microbubbles to bind to desired cell types and essentially pull them up and out of a blood or buffy coat sample.

In their publications, the UCSD researchers used the method to isolate rare spiked-in mouse breast cells, human prostate cancer cells, and pancreatic tumor cells spiked from blood or buffy coat samples faster than and as efficiently as magnetic bead-based isolation — currently the most commonly used method for isolating rare cells from blood.

In addition, the researchers demonstrated that the method could isolate circulating tumor cells from 7 ml of blood or 22 ml of buffy coat from metastatic cancer patients, showing the technique's promise as a clinical tool for isolation, enumeration, and downstream analysis of these cells.

The detection of circulating tumor cells for early cancer diagnosis or therapeutic monitoring has emerged in recent months as a hot area of research for molecular diagnostics developers, and a number of other companies have recently publicized their methods for isolating circulating tumor cells from clinical samples.

For example, Cynvenio Biosystems last year received CLIA certification for its lab to offer clinical and research customers its LiquidBiopsy service, which isolates circulating tumor cells with an automated, antibody-based method for downstream sequencing analysis. Meantime, Biocept is building its cancer diagnosis and monitoring offerings around its OncoCEE technology, which uses microfluidic chambers with thousands of micron-scale posts to enrich and isolate cells of interest from blood samples, followed by highly specific PCR-based assays to detect rare tumor cells.

These are just two examples of several companies that have recently tackled the problem of isolating rare circulating tumor cells, but Benchimol told PCR Insider that Diagnologix's method stands out from the competition because it is "a scalable bulk process, which provides a very gentle non-disruptive method to isolate cells, allowing the cells to be processed, analyzed, or cultured in a number of ways. The technology's ease of use, including the ability to remove the microbubbles without sample contact, makes Diagnologix's technology applicable in a number of clinical and research settings."

Under its new grants, the company will continue to work with UCSD researchers to develop and test a prototype of a more intuitive and user-friendly version of its technology to enable easy washing, immunostaining, culture, and genetic analysis.

Compared to magnetic bead capture, the buoyancy-enabled separation method would provide advantages in speed, sample purity, simplicity, flexibility, minimal final sample volume, and low cost, the researchers claimed in their grant abstracts.

In addition, the method should be compatible with any number of downstream molecular analysis methods, including PCR and sequencing, although the company is not yet focusing heavily on these applications.

"We are working on a few downstream applications relevant to our current project" said Benchimol, adding, "we are interested in forming strategic partnerships with other companies with innovative downstream technologies."

Further down the road, the company may even be able to expand the use of its technology to isolate other biomolecules from fluid samples, for example, cell-free circulating DNA. "Diagnologix's technology is capable of making DNA affinity microbubbles, and [the firm] is still in the process of analyzing [its] potential advantages over competitive technologies," Benchimol said.

The company is currently in the midst of its SBIR grant, which is set to run through September 2015. Meantime, the additional $25,000 in funding it received for 2014 comes courtesy of the NIH/NSF I-Corps program, which provides training for researchers and entrepreneurs who have received SBIR grants, including a nine-week "boot camp" at NIH led by business-savvy instructors with biomedical experience.

These grants are currently Diagnologix's sole source of funding, but Benchimol said that the company is beginning efforts to pursue additional financing to accelerate development.

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