Epigenomics (Berlin) reported the completion of enrollment in its ADMIT trial for its blood-based test for colorectal cancer screening, Epi proColon.
The company said it expects to report results from the study during 2Q15.
Study subjects were identified as historically non-compliant to CRC screening according to current screening guidelines by its partners, Kaiser Permanente and Geisinger Health Systems, who actively manage CRC screening programs in the U.S. Subjects were invited to a clinic visit and once enrolled into the trial, were randomized to either the fecal immunochemical test (FIT) to take home to complete and send back within six weeks, or to a blood draw for the Epi proColon test, to be completed in the same time frame.
The trial was requested by the FDA in the context of Epigenomics' pre-market approval (PMA) application for Epi proColon. It was designed to compare adherence to CRC screening in subjects offered blood-based testing with Epi proColon to stool-based testing with a FIT, a guideline recommended method. The primary endpoint is a statistically significant increase in adherence to testing by subjects offered the Epi proColon test compared to subjects given the FIT test. The study's secondary objectives include a measurement of compliance to colonoscopy in subjects with positive result for either test.
Trial results will be submitted to the FDA following data analysis after completion of the six week response window, the company noted.
LifeCodexx reports proof-of-principal for NIPT assay
LifeCodexx (Constance, Germany) reported the outcome of a proof-of-principle of tis assay for non-invasive prenatal testing (NIPT) based on quantitative real-time PCR (qPCR). This NIPT assay, designed to determine fetal aneuploidies from maternal blood, will offer significant advantages, such as enhanced test performance at affordable prices, over other prenatal examination methods. The study comprised 93 blood samples with eight positive trisomy 21 cases of which the assay unambiguously detected all positive samples.
"This is the first time that a widely used technology platform like PCR has been successfully applied to non-invasive prenatal testing with cell-free DNA. Our new proprietary qPCR-based assay has a clear breakthrough potential in the field of non-invasive prenatal testing on a global scale," said CEO Michael Lutz.
LifeCodexx said it is preparinga bigger blinded validation study with the aim to launch a first CE-marked test in the second half of the year.
"We are enthusiastic about these promising results of this feasibility study," said CSO Wera Hofmann. "Assuming successful validation in large clinical cohorts, our novel assay has the potential to become a true alternative to more expensive technologies, such as next generation sequencing or DNA analysis on microarrays. Compared to these technologies, we are confident that detection rates and false positive rates will significantly improve."
Companies selected for Biovision pitch sessions
Biovision, an annual forum for life sciences organized by the Foundation for the University of Lyon in France, reported the list of companies and projects selected for the investor conference and catalyzer pitching sessions.
The third Biovision catalyzer and investor conference sessions continue to engage project sponsors and start-up participation from France and around the world, the organization said. Between 2013 and 2015, the two sessions respectively received 180 and 200 applications. Many of the young entrepreneurs previously selected or nominated at Biovision have gone on to achieve real success, securing stock market listings, funding and partnership arrangements with major pharmaceutical companies, Biovision said.
The 25 businesses selected for the pitching sessions were chosen by a committee including independent venture capital investors, corporate venture funds, and investment banks.
The businesses selected (see the full list at biovision.org), are split between biotech (15) and med-tech (10) businesses. The majority are European, coming from Ireland, Sweden, Switzerland and France.
All the projects and companies selected will compete in pitching sessions The start-ups and project sponsors selected will also enjoy Biovision and Lyonbiopôle (Lyon, France) support following their attendance at the 2015 event.
"We have received numerous applications for the investor conference and catalyzer sessions again this year. This highlights the level of interest in Biovision as a sounding board and a key event for connecting stakeholders in the life sciences sector," said Didier Hoch, chairman of Biovision. "We believe that the contacts that come out of these presentations will prove beneficial for the entrepreneurs, scientists and investors attending this year."
Prizes will be awarded to the best of the investor conference and catalyzer projects and companies at the Biovision closing ceremony April 16.