Exact gained exclusive rights to technology developed by the Mayo Clinic's David Ahlquist relating to sample processing, analytical testing, and data analysis for non-invasive, stool-based DNA screening for colorectal cancer.
CEO David Deems said that Xceed has decided to engage the FDA early in the development process because the agency's "thinking on these types of tests is evolving" and the company would like to "stay connected to whatever approach they are thinking of putting in place."
The assay, based on the Oncotype DX platform, met the primary endpoint for determining the likelihood of post-operative disease recurrence in patients with stage II colon cancer, but did not meet the endpoint for the ability to predict benefit from post-operative 5-fluorouracil/leucovorin treatment.
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."
A group of researchers from Israel and the US report that they have characterized chromosomal abnormalities in different colorectal cancer stages and identified alterations associated with poor outcomes.