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Agena Bioscience Partners With Diatech Pharmacogenetics to Commercialize Oncology CE-IVD Assays


NEW YORK (GenomeWeb) – Agena Bioscience and Diatech Pharmacogenetics announced last week a partnership to commercialize CE-IVD oncology panels that detect cancer-related genetic mutations.

The assays have been developed by Diatech and run on Agena's MassArray Dx Plus system. Financial terms of the deal were not disclosed.

Agena acquired the MassArray portfolio from Sequenom when that firm divested its biosciences division last June. In February, Agena CEO Peter Dansky told GenomeWeb that the San Diego, California-based firm would soon launch a CE-IVD product and would look to build out its menu of tests.

In an interview this week, Dansky asserted Agena's strategy is to move the MassArray technology from what had been primarily a research tool into a workhorse in the clinical lab and other industrial labs.

The Diatech partnership, therefore, "is pretty much what we had lined up as a first step to get into the broader European market with the IVD product," he said.

The oncology panels themselves are manufactured by Diatech, but they have a significant component of Agena technology in them, he noted.

At launch, the system will be essentially the same product as one marketed by Diatech in Italy, called Myriapod. In the future, development of the systems may diverge depending on each company's strategy. That flexibility has been built into the partnership as well, Dansky said.

The system will keep the Myriapod branding in the Italian market, but will be branded under Agena's name in Germany, France, and the UK.

"Outside of Italy, [Agena is] the commercialization arm [for] all sales, marketing, support, and interacting with customers," Dansky said.

The Myriapod system has already been adopted by a number of oncology labs in Italy, although the firms have declined to give specific details on number of placements. There are no peer-reviewed studies as of yet, but "the analytical and clinical validity, and all the data that's associated with a CE-IVD certification has been done by Diatech," Dansky said.

Two assays are the current commercialization focus, with more potentially in the pipeline, and each assay is essentially a panel of 200 or so mutations.

"These markers are well established, and they were chosen because they are clinically relevant, part of the standard clinical guidelines, and, importantly, reimbursable within the medical system," Dansky said.

Specifically, a colon cancer panel detects "the usual suspects" of mutations in four genes — KRAS, NRAS, BRAF, and PIK3ca, while a lung cancer panel detects mutations in some of these same genes as well as EGFR, ALK, and a few others that are less well known, Dansky said.

"The proof has been in the customer adoption in the hospital labs; these tests are being run routinely with great success within Italy, and that gave us a lot of confidence in the value of the menu and the effectiveness of the whole solution to be able to take it now more broadly across Europe," he said.

Diatech also has panels for melanoma, cystic fibrosis, and a general pharmacogenomics panel. Those are not launching at this time, but the firms are going to evaluate them in the future, Dansky said.

The assays run on Agena's 96-well format system using standard nanodispensing. The company recently launched a chip-prep module that has upfront automation for handling the manual steps involved with processing the firm's chip arrays, and Dansky said he expects that will be added to this offering in the future.

The mutations detected by the panels are ones often correlated with treatment, and though Dansky said the MassArray technology would be a great platform for companion diagnostics, that's not a primary focus for Agena because the firm sees a lot of opportunity in the nearer term in more established markers and treatments.

"What is special around these assays is that the drugs are on the market, the mutations that are associated with their use are well established in clinical guidelines, and so clinical laboratories are asked to provide these results routinely — there are even reimbursement guidelines that are independent of a new drug launch or a particular pharmaceutical company," Dansky said.

"That suits our strategy very well. We have a very efficient platform, and we're interested in actionable mutations that we can provide to a clinical lab," he added.

While it is a strategy of the company to eventually explore companion diagnostic opportunities, such products would be a ways out in terms of commercialization, Dansky said.

Agena also intends to establish an FDA-cleared menu in the future, but it may not be with the specific products being co-developed with Diatech. The firm will also continue to look into partnership opportunities as well as in-house-developed solutions for the clinical market, Dansky said.