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Theranostics Looks for Med Fusion Deal to Aid in Clinical Validation, Payor Access

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With a recent market development agreement with clinical trial services company Med Fusion, Theranostics Health continues its push to bring its first protein diagnostic product to market in early 2013.

And while the Med Fusion deal, announced earlier this month, will focus initially on clinical validation of Theranostics' assays, Ron Hencin, Theranostics' vice president of business development, said the company expects the agreement will eventually play a key role in helping it obtain coverage for the test, as Theranostics will have access to a large network of payors through Med Fusion and its partners McKesson, Texas Oncology, and Baylor Healthcare.

Med Fusion's mission "is to get new technologies rapidly into the hands" of these partners, Hencin told ProteoMonitor. "Through [those partners] they have a very large network of payors that we will be able to bring on board very early to get reimbursement for the test."

Given the struggles that protein diagnostics firms like Vermillion have experienced in obtaining reimbursement, even after clinical validation and US Food & Drug Administration approval of their products (PM 3/30/2012), this could prove an important feature of the deal.

The agreement provides no guarantees of coverage from payors affiliated with Med Fusion, Hencin said, noting that the company "still [has] to go through the process like anyone else doing a laboratory-developed test." But, he said, the hope is that "because of the relationship [to these payors], we should be able to fast-track the reimbursement rate for those particular groups."

More immediately, Med Fusion is helping Theranostics clinically validate its lead product – a test intended to guide therapy in breast cancer patients and to supplement and improve upon conventional HER2 testing. Theranostics hopes to launch that product as a laboratory-developed test out of its CLIA laboratory in the first quarter of next year.

Med Fusion is "serving as a great source of [clinical] material for validation of our test," Hencin said. "They've got retrospective samples in their system and then we'll also be doing prospective [sample] collection with them … that will enable us to do the validation necessary for our first diagnostic assay."

Theranostics in 2006 spun out of the labs of George Mason University researchers Lance Liotta and Emanuel Petricoin – now both members of the firm's scientific advisory board – with the aim of commercializing the duo's laser capture microdissection and reverse phase protein array technologies. The company measures protein signaling levels to develop profiles that can help identify patients that might respond to a particular drug and track those patients progress.

Theranostics is currently involved in a small pilot study with Med Fusion "to work out the logistics of working with them and their network," Hencin said, adding that "we'll be expanding into additional studies very rapidly."

He said that Theranostics plans to start prospective trials for its breast cancer test in collaboration with Med Fusion within the next few months.

The collaboration will also provide Theranostics with early adopters for the test, Hencin said. "They're going to be using their network of oncology organizations as the early adopters of our tests, so we'll be able to get the test rapidly in the hands of oncologists."

Theranostics will provide these initial adopters with the test "essentially for free, as you do when you're putting something out in something like a beta mode," he said.

The Med Fusion agreement does not currently involve any partnership with pharma firms, Hencin said, but he noted this was something both parties were open to. He added that Theranostics is in discussions with other groups regarding pharma collaborations, although he declined to name any specifically.

While the deal will initially focus on Theranostics' breast cancer test, Hencin said it can be expanded to cover any future tests coming out of the company's pipeline.

Coming next is most likely a diagnostic for patients with metastatic colorectal cancer, he said. It also has ongoing a prospective trial in pancreatic cancer.

In addition to Med Fusion, the company has continuing collaborations with other research groups, Hencin said, citing in particular work on pancreatic cancer being done with researchers at Georgetown University's Lombardi Cancer Center and Seattle's Virginia Mason Hospital.

One of the company's primary collaborators on its breast cancer work has been Duke University researcher Victoria Seewaldt, director of the prevention program at the university's Comprehensive Cancer Center. In collaboration with Theranostics, Seewaldt has identified a series of breast cancer signatures – each comprising roughly 15 proteins in the Akt/mTOR/PI3K/cSrc, EGFR/MEK/ERK, and HER2/bcl-2 pathways – that could help identify precancerous women at high risk of developing the disease as well as predict the effectiveness in particular patients of preventive agents like tamoxifen (PM 11/12/2010).

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