NEW YORK (GenomeWeb News) – Epigenomics today announced that a US Food and Drug Administration panel voted in favor of the company’s Epi proColon colorectal cancer screening test but with concerns.
In a meeting held on Wednesday, the Molecular and Clinical Genetics Panel of FDA's Medical Devices Advisory Committee voted that the benefits of the test outweigh the risk for use in patients "who meet the criteria," Epigenomics said.
The panel voted on three questions. On whether Epi proColon is safe to use in the target population, the panel voted 9-0 in favor with one abstention. The panel was tied 5-5 with one abstention on the effectiveness of the test in the intended population, Epigenomics said, adding the panel chairperson voted unfavorably in order to break the tie.
Lastly, the panel voted 5-4 with one abstention in favor of whether Epi proColon's benefits outweigh the risks in use of the test for the intended population.
Epigenomics noted, though, that the panel raised questions about a lack of long-term data around the programmatic use of the test. To address this concern, the company said it plans to conduct a post-approval study to "investigate the longitudinal performance of the test in a screening situation, in order to assess the long-term benefits of" Epi proColon for colorectal cancer screening.
It added that it will meet with the FDA's premarket approval review team in about four to six weeks to discuss a product label that would address the panel's concerns, as well as the design of the post-approval study.
Epigenomics filed its PMA submission early last year.
While FDA will take the panel's recommendations into consideration as it decides whether to approve Epi proColon, the agency does not have to follow them, and one analyst cast doubt on approval of the test following the panel's meeting.
In a research note, Brandon Couillard of Jefferies said that the panel meeting "did not go well," as the members "were critical of the test's performance relative to other non-invasive options," including fecal immunochemical tests and fecal occult blood tests.
"All in all, [Epi proColon's] ability to gain FDA approval appears questionable," Couillard said.
Today, the same panel will discuss Exact Sciences' PMA submission for its Cologuard colorectal cancer screening test. The Nasdaq has halted trading of the company's shares while the meeting takes place.