NEW YORK (GenomeWeb News) – The UBS Global Life Sciences Conference concluded on Wednesday with presentations in the afternoon by GenturaDx and Epigenomics.
Below are highlights from their pitches to investors.
The company announced a restructuring in August that resulted in a cut in its workforce and an increased focus on its US business.
On Wednesday CEO Geert Nygaard reiterated the firm's commitment to the US market, saying that the company began this week a pivotal clinical study for its Epi proColon 2.0 test in preparation of a submission to the US Food and Drug Administration.
The test, a second-generation version of the original Epi proColon blood-based DNA methylation test for colon cancer achieved 95 percent sensitivity and 85 percent specificity in a clinical study of 247 patients. Those figures compare to 67 percent sensitivity and 88 percent specificity on the original test achieved on a prospective validation study.
The pivotal clinical trial for FDA submission will have a cohort of 8,000 subjects and all blood samples for it have been collected, Nygaard said. He added that data for the study is expected in the fourth quarter.
"We are very confident we will submit for [premarket approval] submission before the end of the year," he said, and noted that he anticipates FDA approval for the test as a PMA in late 2012 or early 2013.
Epigenomics will launch the Epi proColon 2.0 in Europe during the fourth quarter of this year.
Based in Hayward, Calif., GenturaDx is developing a PCR-based molecular diagnostic platform that it is positioning to compete with Cepheid and Becton Dickinson, GenturaDx CEO Mark Bagnall said.
The system has completed its alpha testing and is in beta testing now. Clinical trials for the system for a planned submission to the US Food and Drug Administration are expected in early 2012. Priced at $50,000, the benchtop, multiplex system — comprising an instrument, disposable cartridges, and proprietary PCR technology — will compete directly with Cepheid's GeneXpert XVI and the BD Max systems, Bagnall said.
Mapping out a timeline for goals, he said that in the first quarter of 2012 GenturaDx hopes to reach a development agreement for the system with a partner, adding that it currently is in discussions with several companies.
In the second quarter of 2012 it plans to conduct clinical trials for a herpes simplex virus test, and in Q3 it hopes to initiate beta studies for a respiratory panel. In the fourth quarter of 2012, it plans to submit to FDA a test for HSV, with a launch date for a test for HSV 1 and 2 typing in the first half of 2013.
Other initial tests for the platform are a respiratory panel for the second half of 2013 and a C. difficile test, also set for the second half of 2013.