Citing the FDA's handling of KRAS testing for anti-EGFR monoclonal antibodies, the report asserts that in the near term complex genetic tests such as Oncotype DX should be "performed through CLIA labs, and not held up by slow regulatory processes."
As part of the deal, Merck will pay Xencor a $3 million upfront license fee, make an additional payment if it selects an Xtend variant, and pay clinical development milestones and royalties on product sales.
NKT licensed the IP from Beth Israel Deaconess Medical Center, Dana-Farber Cancer Institute, and Massachusetts General Hospital. As a result, each of the Harvard Med-affiliated institutes has been awarded an undisclosed equity stake in the company.
The decision, part of the state's 2010 budget, will allow life-sci shops in FY2011 to determine the percentage of corporate income taxes they owe the state based solely on sales, rather than combining sales with payroll and owned property.