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Theranostics Health to Launch HER Signaling Assay, Marking Firm's First Commercial Test Release

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Theranostics Health this week announced the June launch of its first commercial test, a 14-protein assay for profiling activation of the HER signaling network.

The test, named the TheraLink HER Family Assay, is intended as a supplement to conventional HER2 testing for guiding therapy in breast cancer patients. The company plans an initial focus on metastatic cases where there are few existing treatment guidelines, Theranostics President and CEO Glenn Hoke told ProteoMonitor.

The company will launch the test in collaboration with clinical trial services company Med Fusion, with which Theranostics signed a market development agreement last year (PM 8/31/2012). That deal focused primarily on clinical validation of the TheraLink HER test. However, said Ron Hencin, Theranostics' vice president of business development, the company anticipates that it will also help drive sales and reimbursement of the HER test through access to Med Fusion's partners McKesson, Texas Oncology, and Baylor Healthcare, and their networks of oncologists and payors.

Beyond metastatic breast cancer cases, Hoke said, Theranostics anticipates that the TheraLink product will also prove useful as a follow-up to conventional HER2 testing in cases where the test result is equivocal. It could also find a market among doctors concerned about the reliability of conventional HER2 testing, he said.

"I think we are going to start in metastatic [breast cancer], and then we are slowly going to start migrating into [use in] those [cases] that are equivocal or where doctors just want a little more information," he said.

Conventional HER2 testing uses techniques including immunohistochemistry, ELISA, and fluorescence in situ hybridization to measure levels of HER2 protein or gene expression to determine if patients are good candidates for treatment with anti-HER2 therapies like Roche's Herceptin (trastuzumab). There are concerns about these tests' reliability, however, with some analyses suggesting that their results might be inaccurate up to 20 percent of the time.

In addition to accuracy concerns, recent studies have also suggested that conventional HER2 testing might miss some patients who could benefit from anti-HER2 therapy. For instance, a recent study led by George Mason University researcher Emanuel Petricoin – a co-founder of Theranostics and the chairman of its scientific advisory board – identified in a cohort of 415 breast cancer patients, a subset of roughly 40 who, while negative for HER2 according to conventional IHC and FISH tests, showed phosphorylated HER2 and activation of HER2 signaling pathways (PM 10/12/2012).

Petricoin and his colleagues performed their work using the same reverse-phase protein array technology Theranostics uses for its assays. The technology allows the company to measure phosphorylation levels across a number of proteins, enabling it to build profiles of protein signaling activity in key cancer pathways like HER. This enables clinicians to identify pathways dysregulated in cancer patients and prescribe therapies targeting those pathways.

In addition to the TheraLink HER assay, Theranostics is also working on an expanded version of the test that it plans to launch by the end of the year. That test will gauge more than 30 proteins and offer analysis of additional key cancer signaling pathways like ALK, MET, and JAK, Hoke said.

The company envisions simultaneously expanding the applications of the HER assay to include colorectal and lung cancers where anti-HER therapies might be an option, he added. It plans to add a pancreatic cancer panel to the test sometime in 2014.

"We see by the end of the year being able to migrate from the [initial 14-protein test] to the expanded panel and that is going to allow you to address a lot more types of cancers," Hoke said, adding that the company was currently in the middle of validation studies for the breast, colorectal, and lung cancer applications.

Hoke said that the company planned to offer all the panels as a single test, but, Hencin noted, that could change if physician feedback indicated a desire for smaller more specialized panels.

"It will also be somewhat cost driven, because the initial test will go out at a lower price point than the larger follow-on test," Hencin said. "So the two may be able to co-exist on the market because for a particular indication you may only need the 14[-protein] panel, and so you don't want to incur the extra cost of the expanded panel."

Theranostics will offer the 14-protein panel for around $2,500 and the expanded panel for around $6,000, he said. It will run the test out of its CLIA lab.

Currently, Hoke said, the company has the capacity to run between 10,000 and 12,000 samples per year with around a five-day internal turnaround. The company is currently in the process of closing a $2 million to $3 million funding round and is planning a $5 million to $10 million round for next year, the proceeds of which will be used in part to expand its sample processing throughput, if such expansion is needed.

Theranostics sees its relationship with Med Fusion as key to driving commercialization of the test. Med Fusion's founders include McKesson, Texas Oncology, and Baylor Healthcare, which, between them, offer access to roughly 2,000 oncologists, Hoke noted.

"Our [initial] goal is to get these 2,000 doctors using the test," he said. The company also has several presentations on the test planned for the upcoming American Society of Clinical Oncology annual meeting and is collaborating with researchers at medical centers including Georgetown University's Lombardi Cancer Center on studies involving the test that it hopes will result in peer-reviewed publications.

"You can put your test out, but until you have somebody mention it at a larger national or international meeting and present data on it, it's hard to get traction," Hoke said. "Once the clinical utility [of a test] is being talked about by other doctors, that is when everybody really starts to get onboard. We think that's the advantage Med Fusion [and the physician access it offers] brings us."

In addition to its test development business, Theranostics also offers drug development services to pharmaceutical firms and, Hoke said, is currently involved in several clinical trials using its technology to help assess treatment efficacy and stratify patient cohorts.

He added that the company might at some point pursue companion diagnostic development, but it has no immediate plans to do so.

"Our [HER] test is therapy agnostic," Hoke said. "Our test doesn't say, 'Give company A's drug or company B's drug or company C's drug.'

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