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After Expanding Breast Cancer Assay, Theranostics to Launch Colorectal, Pancreatic Cancer Tests


NEW YORK(GenomeWeb News) – Proteomic diagnostics firm Theranostics Health has in recent months expanded its TheraLink Assay for breast cancer and plans at the end of this month to launch new assays targeting colorectal and pancreatic cancer.

In April, Theranostics released a next-generation version of its lead product, a reverse-phase protein array (RPPA) assay for assessing the activity of breast cancer signaling pathways with the aim of guiding patient therapy. The new assay adds 10 more analytes to  the original 14-analyte TheraLink test the company launched in 2013, and expands its reach to pathways beyond the HER family.

Now, Theranostics is preparing assays to guide therapy in colorectal and pancreatic cancer patients, Luis Gutierrez, the company's president and CEO, told GenomeWeb.

Both assays will share content with the breast cancer test, he said. Of the 23 targets measured by the colorectal cancer test, 22 are also included in the breast cancer assay. The pancreatic cancer assay shares four analytes with the breast and colorectal cancer tests, Gutierrez said.

The overlap between the test points to the ongoing rethink of cancer classification and, indeed, the basic rationale underpinning Theranostics' offerings, said George Mason University researcher Emanuel Petricoin, who with his GMU colleague Lance Liotta co-founded the company in 2006 and now chairs its scientific advisory board.

"The science is pointing to a redefinition of cancer from an organ-specific definition to a pathway-specific definition," he told GenomeWeb. So, in keeping with that, a large number of the analytes that are on the TheraLink assay for breast cancer are also on the pancreatic and colorectal cancer assays, because these represent core druggable pathways."

"The TheraLink assay is philosophically tied to the idea that we will start to drug cancers not by site of origin but by their molecular defects," Petricoin said.

Petricoin has been a leading proponent of this point of view, particularly from the perspective of protein signaling. Using the RPPA technology he developed in collaboration with Liotta, he has been active in efforts, both within his lab and as part of larger studies, exploring the extent to which protein signaling profiles can be used to predict patient response to therapies targeting those signaling networks.

For instance, in 2013, Petricoin and collaborators presented data at the American Society of Clinical Oncology's annual meeting in which they used molecular profiling techniques, including RPPA, to guide treatment in 25 metastatic breast cancer sufferers, finding that in 13 of these 25 subjects, the molecularly guided therapies extended progression-free survival by more than 30 percent compared to the patient's previous treatment regimen. 

In research more directly relevant to the TheraLink breast cancer assay, work by Petricoin within the I-SPY-2 breast cancer trial found that the marker phosphorylated EGFR 1173 improved upon existing markers like HER2 and HR status in predicting patient response to Puma Biotechnology's tyrosine kinase inhibitor neratinib while at the same time expanding the population of patients considered likely responders to the drug. Phosphorylated EGFR 1173 is one of the analytes measured by the TheraLink breast cancer assay.

And, last month, at the American Society of Clinical Oncology annual meeting, researchers presented additional work from I-SPY-2 finding that, even in triple-negative breast cancer patients, phosphorylated HER2 and EGFR helped predict which patients would benefit from neratinib.

The findings, Petricoin said, highlight the benefit of Theranostics' approach, which focuses not so much on measuring the total levels of cancer signaling proteins but rather on determining their activation levels by assessing their phosphorylation status.

Triple-negative breast cancer patients are thought to express no or very low levels of HER2, Petricoin noted. "So, you could say, 'how are you measuring a molecule that is absent?'"

"But what we showed is that there is activated HER2 even in patients with very low levels [of the protein]," he said. And those patients where the activation level is high, despite the total level of HER2 protein being very low, received clinical benefit from neratinib.

This, Petricoin said, "was a very exciting finding for patients with triple-negative breast cancer, because they are desperate for drugs that work."

"So we are trying to position the TheraLink test as the only commercially available test that actually measures whether or not these pathways are activated," he said. "And this specific piece of intellectual property is important because HER2 activation is found in a variety of tumor types. Certainly breast cancer, but colorectal and prostate and lung, as well."

Theranostics is starting clinical trials in several cancer types including breast, lung, pancreatic, ovarian, and colorectal, Gutierrez said. It will be presenting two posters on new research at the annual ASCO Breast Cancer Symposium this September, he added.

The company offers the TheraLink Breast assay out of its CLIA lab. Last month the company was awarded a license to operate inCalifornia, and it is currently working towards obtaining licenses inNew YorkandFlorida, upon which it will be able to offer its tests nationwide, Gutierrez said.

Theranostics has driven commercialization of Theralink primarily through a market development agreement it signed with Med Fusion in 2012. Gutierrez declined to provide sales numbers or revenue figures for the test.

The test is not currently reimbursed, though the company does have in place an agreement with South Dakota-based Avera Health Plan under which Avera is providing provisional coverage and reimbursement for its employees and their dependents as part of a one-year evaluation program.

Test volume is not yet significant enough for Theranostics to apply for national coverage decisions from insurers, Gutierrez said, but, he added, the company does submit all performed tests for reimbursement and has met with what he calld "pretty decent success."

"It is a heartening revenue stream we get even without balance billing patients, which we are not doing at the moment," he said.

The company bills insurers $2,500 per test. "Sometimes we get reimbursed that amount. More often we get a percentage of that," Gutierrez said.

He suggested that the company has benefited from insurers' interest in better targeting of therapies to patients who are most likely to actually to benefit.

"There is a logic there that it is worth paying for this test so that the prescribing oncologist is not shooting blind," he said. "At this point do we have a double-blind randomized control trial? No. But on a case-by-case basis when [insurers] read what the test does, that we are testing for the actual drug targets that are enumerated in the package inserts of the drugs in question there is a logic [to it], and that is, in essence, why we are having decent success."

The TheraLink assay does not have a specific "label or indication, per se," Gutierrez said, but the company is targeting the test toward late-stage patients.

"We're not seeing use in first-line, primary tumors. There [doctors] go with standard of care," he said. "Our logical entry point is once standard of care isn't working."

Turnaround time for the assay is 10 business days.

Theranostics currently has 12 employees and is funded by a number of individual investors, Gutierrez said, adding that it has not yet taken any VC funding. Last year, Chief Operating Officer Glenn Hoke told GenomeWeb that the company was looking to raise around $10 million in funding. Gutierrez said this week that Theranostics was still targeting this funding and had retained Ernst & Young Capital Advisors to assist with the process.