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Helomics Continues Research Market Shift With Two New Components for Live Cell Platform

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NEW YORK (GenomeWeb) – In line with its change of name and realignment of focus last year, Helomics (formerly Precision Therapeutics) announced this week the launch of two new components for its live-cell based analysis services, which combines 'omics and other biological analyses to understand a patient's cancer.

President and CEO Neil Campbell joined the company in November 2014 when it changed its name and began a shift from a narrower focus on chemosensitivity and genetic testing to expand the capabilities of its live cell platform.

Campbell told GenomeWeb this week that the two new components — an expansion of the company's live-cell analysis capabilities called CellFx, and a tumor shedding analysis called Defender that is intended to serve as a virtual parallel to liquid biopsies — reflect the company's goals to more fully realize the potential of its technology and expand its activities in the research sphere.

Both CellFx and the Defender live cell liquid biopsy system are for research customers initially, but Helomics also plans to collect data this year to support payor coverage of these added analyses in the clinical market.

The company's base technology, which each of these new components now complement, is a live cell analysis method called the Precision Cellular Analytical Platform (PCAP).

Clinically, the platform supports comprehensive tumor profiling that includes data derived from growing and cycling a cancer patient's cells, chemosensitivity testing of these live cells, and genomic and proteomic analyses of fixed, non-live cells. The suite of analyses is intended to help physicians understand the fundamental biological processes of a patient’s individual tumor and make informed treatment decisions tailored to a patients’ specific malignancy.

At the time that Helomics launched under its new name, Campbell said that the company's business was predominantly clinical, but that the goal over the last months, and continuing this year is to move to a 60/40 revenue split between the research and clinical markets. "We pretty much launched the research business in the late fall," he said. Now, announcing CellFx and Defender, the company is hoping to attract customers who could use the technology in different ways.

According to Campbell, CellFx involves new proprietary enhancements of the company's core live-cell technology that it has been working on over the last year, which allow Helomics to characterize tumor biology even more fully.

More specifically, he said, it adds capabilities in assessing cell shape, growth rate, surface markers, and evolution over time, using algorithms that support different types of photography of growing cells, morphology analyses, special relationships, and cells' effects on one another in proximity.

This type of breadth and granularity is something the field is increasingly recognizing as necessary to resolve the research and clinical questions that simplistic analyses — for example, looking only at genomic alterations, physical phenotypes, or protein expression — have failed to answer.

"With BRCA for example," Campbell said, "just because you are positive doesn't mean that mutation actually is affecting your cancer. You can have two patients that are BRCA-positive, and one patient's mutation may be playing a role while the other's isn’t."

With the Defender live cell liquid biopsy system, Helomics is moving in a different direction that it also believes expands the granularity and comprehensiveness of its analysis services.

Just as a tumor sheds material into the blood stream in the human body, live cancer cells in Helomics' PCAP shed molecules into the liquid medium that the platform utilizes. Defender is essentially a virtual liquid biopsy analysis that looks at this shed material and tracks cancer evolution over time in parallel with actual liquid biopsies of patient's blood or other body fluids.

"Liquid biopsies can't pick up everything the tumor is shedding in a patient because you are taking a sample from a fixed moment only, so what we can do is look at what is being shed from a live tumor and compare that to what we might see in blood and urine to give a more complete picture" Campbell explained.

He did not detail how Helomics' push to gain customers in the research and pharmaceutical markets is going, or name any new partners, but he said that a particularly ripe application for these new components of the PCAP, especially the Defender liquid biopsy approach, is in cancer immunotherapy development and clinical research.

He said other customers for the firms's services are pharma or biotech companies focused on the development of biosimilars. Helomics is also pursuing subcontract work for CROs and other specialty research groups.

Though both CellFx and Defender are being put forward for research only purposes right now, Campbell said Helomics is collecting data to make a case to payors that they should consider covering clinical comprehensive live-cell and genomic testing that includes these new components.

The company currently markets a clinical PCAP analysis, which includes a chemosensitivity tests called ChemoFx. Campbell told GenomeWeb that sales for that flagship product have gone up over the last year, with the test now being used in 250 of the top US hospitals.

In addition to the company's clinical comprehensive tumor profiling, which includes both the live-cell assays, and genomic and proteomic testing of fixed cells, Helomics also offers two specific genetics tests.

GeneFx Colon is a microarray-based test for stage II colon cancer patients, intended to identify patients who are up to 150 percent more likely to experience recurrence within five years of initial surgery. It was licensed by Helomics from Almac Diagnostics.

GeneFx Lung, is an array-based 15-gene assay licensed from Med BioGene, which identifies stage I and II non-small cell lung cancer patients at a two- to threefold risk of recurrence within five years following initial surgery.

Campbell added that Helomics is hoping to "rapidly" make similar acquisitions or licensing deals to expand its clinical and research testing services to cover all solid tumors types.

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