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Ovagene Deal Highlights HTG Molecular's Strategy of Being Platform Provider for MDx Firms

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HTG Molecular announced a deal with Ovagene Oncology this week that will see Ovagene adopt HTG's Edge System for its menu of gynecological cancer-focused tests.

While the deal with Ovagene is the first that Tucson, Ariz.-based HTG has discussed publicly, the firm has concluded similar agreements with unnamed customers since it launched the Edge last year, and will certainly not be the last, according to its CEO TJ Johnson.

"We will be doing more deals like this," said Johnson. "It is an important aspect of [our] strategy."

Johnson told BioArray News that HTG has installed 10 of the systems since it was introduced to early adopters in May 2013, followed by its full commercial launch last November.

He said that the systems are "being used for multiple assays [by] multiple customers," and stated that HTG sees itself solely as the platform provider for these assays, assuming a role similar to Affymetrix or Luminex in terms of providing instruments and reagents that are used by CLIA-compliant labs to run laboratory-developed tests.

Moreover, HTG expects this trend of platform adoption to continue, given planned investments in its sales and marketing activities. "We are currently ramping up US field sales and sales support resources and have launched in Europe," noted Johnson.

HTG's Edge System is an automated RNA expression platform that supports extraction-free, multiplexed results on diverse biological samples in about 24 hours. Using the Edge, researchers can profile the expression of 47 different genes per well using 96-well plates.

The system is based around HTG Molecular's quantitative nuclease protection technology, meaning that assays running on the Edge do not require RNA extraction, amplification, or labeling. In addition, the Edge was developed to enable the analysis of formalin-fixed, paraffin-embedded samples, according to the firm.

The Edge system is currently optimized for profiling mRNA and microRNA, Johnson said. The company has built out a menu of assays for use on the system. The DMPK Core CYP Assay profiles six genes suggested by the US Food and Drug Administration for drug-drug interactions and drug safety; the DMPK Assay profiles 45 genes associated with drug metabolism and pharmacokinetics; and HTG's Top Oncogene Assay measures expression levels of 32 of the most commonly assayed oncogenes. This quarter the company introduced its FGFR Expression Assay, which measures the expression of the four core FGFR receptors, 23 known FGFR? ligands, and two additional genes known to be critical in FGFR Receptor function; and its Immunotherapy Assay which contains 26 commonly investigated immunotherapy-related genes.

And more assays are in development. Johnson said that the company's assay for profiling the expression of fusion genes is "80 percent complete" and should become available in the second half of the year. "We are adding two or three new assays per quarter," said Johnson.

However, HTG will not be adding Ovagene's assays to that menyInstead the Irvine, Calif.-based molecular diagnostics firm will offer HTG-based tests through its own lab. Ovagene offers a number of assays for ovarian and cervical cancers, including its OvariGene Molecular Drug Response Panel, its CerviGene Molecular Therapy Response Panel, and its Kay's Array Targeted Therapy Panel.

According to OvaGene CEO Frank Kiesner, the firm "recognized right away that HTG's technology would help us improve our workflow and reduce turnaround time to our customers and ultimately patients while providing superior quality data." In addition, the system will "allow us to expand our specimen type to ascites and smaller samples such as biopsies," he said in a statement.

EdgeSeq

HTG's deal with Ovagene was announced ahead of the launch of its new EdgeSeq automated sample and library preparation platform next month.

Johnson said that EdgeSeq will allow researchers to prepare sample libraries prior to sequencing using Illumina's next-generation sequencing instruments. The first EdgeSeq assay will support microRNA expression profiling.

The company is billing EdgeSeq as targeted RNA sequencing that combines its extraction-free, high-specificity Edge Chemistry with the sensitivity and range of next-gen sequencing, enabling digital quantitation of miRNA and mRNA expression from multiple sample types, including FFPE samples.

HTG Molecular is currently prepared to introduce two EdgeSeq assays. The first is the EdgeSeq miRNA Whole Transcriptome Assay, which will allow users to digitally quantitate the expression of the miRNA transcriptome in a single reaction. The firm has also developed its EdgeSeq Oncology Biomarker Panel, which enables customers to digitally quantitate expression of 3,000 oncology biomarkers in a single reaction.

Johnson said that HTG Molecular anticipates introducing two or three EdgeSeq assays per quarter following the application's debut.

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