Blood Test Detects Colorectal Cancers and Pre-cancerous Polyps
Colorectal Cancers targeted for blood test screening
A new blood test was reported to detect 80 percent of stage 1 colorectal cancers in a new screening study.
VolitionRx Limited announced these interim results from its first asymptomatic colorectal cancer (CRC) frontline screening study in collaboration with Hvidovre Hospital, University of Copenhagen, Denmark.
These tests are based on what the VolitionRx calls “nucleosomics,” or the practice of measuring nucleosomes in blood or other bodily fluids.
Cameron Reynolds, CEO of VolitionRx, said in a press release “We believe that with further development, our Nu.Q panel could form the basis of new colorectal cancer tests with early-stage disease detection and that our tests could become accessible to and usable by a wide section of the screening population around the world.”
In the USA, VolitionRx is participating in what is believed to be the largest ever CRC screening study in collaboration with the National Cancer Institute's Early Detection Research Network with a cohort of over 13,500 subjects.
The objective is to present final data to the FDA prior to completion of the study. VolitionRx expects to define the final panel for the U.S. front-line test within the next 18 months.
In the USA, the lifetime risk of developing colorectal cancer is approximately 4.3 percent of men and women, based on 2012-2014 data from Cancer.gov.
In 2014, there were an estimated 1,317,247 people living with colorectal cancer in the United States.
Stage I colon cancers have grown deeper into the layers of the colon wall, but they have not spread outside the colon wall itself or into the nearby lymph nodes, says Cancer.org.
Stage I includes cancers that were part of a polyp. If the polyp is removed completely during colonoscopy, with no cancer cells at the edges of the removed piece, no other treatment may be needed.
If cancer in the polyp is high grade or there are cancer cells at the edges of the polyp, surgery might be recommended. For cancers not in a polyp, partial colectomy is the standard treatment, says Cancer.org.
VolitionRx plans to continue ramping up trials for the blood test this year. The next study, scheduled to begin in the second quarter of 2018, will include 4,300 participants and will help determine which assays to use in the final test panel, which the company expects will include five to six assays.
In this study, blood samples were taken from 579 asymptomatic subjects, who participated in the Danish National CRC Screening Program.
The blood samples, which were collected according to a validated Standard Operation Procedure, were assayed by ELISA and the results analyzed using Logistic Regression. Both age and smoking were included as patient variables.
All assay results were highly statistically significant for both Stage I cancer and HRA detection. The panel reported includes two proprietary assays and one non-proprietary assay, said VolitionRx.
Dr. Jake Micallef, VolitionRx's Chief Scientific Officer said "We are progressing towards obtaining a CE Mark for this panel so that the Nu.QTM Frontline Asymptomatic Colorectal Cancer Screening Test could be available for sale in the EU later this year."
About VolitionRx Limited - Volition is a multinational life sciences company developing simple, easy to use blood-based cancer tests to accurately diagnose a range of cancers.