Volition Reports Breakthrough in Liquid Biopsy: Achievement of over 99% Purity in Isolating Cancer DNA
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Targets
$36 Billion TAM in Early Cancer Detection and MRD. - Company in active discussions with global diagnostic leaders to accelerate commercialization .
The biggest problem facing liquid biopsy worldwide is that the vast majority of circulating DNA in blood plasma samples comes from healthy cells, not cancer cells. In a world first new technology, Volition has overcome this hurdle and produced >99% pure cancer derived plasma DNA sequence sets for liquid biopsy.
Dr
"Distinguishing cancer derived plasma DNA from healthy DNA when the two are mixed is problematic. When the cancer DNA makes up 1% or less of the total DNA it is extremely problematic. Moreover, DNA from cancer and healthy cells has the same double helix structure and has never before been separated chemically.
"Our manuscript, submitted in November and previously announced in
"Removal of background normal cell free DNA from the blood to reveal this level of tumor derived DNA has been a long term goal of liquid biopsy. I believe this is a world-first and could, in my opinion, represent the biggest scientific breakthrough in cancer testing and monitoring in recent years.
"In this updated manuscript we report a new, two-step method for preparing pure circulating tumor DNA data sets for cancer patients:
i. physical enrichment of the sample and
ii. bioinformatic removal of virtually all remaining non-tumor cfDNA sequences from the DNA sequence data set.
"This new method produced >99% pure ctDNA sequencing data sets for blood samples from cancer patients and, whilst we capture a subset of the ctDNA (i.e. not all the ctDNA in a sample), it is virtually pure cancer DNA.
"These methodological and technological breakthroughs represent a novel liquid biopsy method for a novel class of potentially thousands of liquid biopsy sequence biomarkers.
We call this technology "Capture-Seq™" and it shows potential for both a multi-cancer early detection (MCED) approach, either alone or in combination with other tests, and the detection of Minimal Residual Disease.
"Volition is, I believe, the first liquid biopsy company to focus on circulating cell free nucleoproteins and we have filed a number of new patents to protect this technology."
Dr
"From a clinical perspective, the proof of concept and early blinded validation results reported in this paper are extremely encouraging. In two independent cohorts we reported no false positives and detected 49/49 cancers in the first cohort (including 23 early stage I/II and 21 controls) and validated it in a second blinded cohort with 13/14 later stage cancers detected with 10 additional controls We are now working on a further validation cohort of early stage cancers, and expect this data soon.
"For patients, the potential significance is huge. If validated in larger cohorts, CTCF Capture-Seq™ could contribute to multi-cancer early detection and disease management, particularly in combination with Volition's existing Nu.Q® assay for lung cancer (H3K27me3) but potentially in combination with other technologies too."
Mr. Gael Forterre, Chief Commercial Officer, Volition added:
"This scientific breakthrough has generated a lot of interest with potential licensing partners.
"We feel that this technology could, with further development, become very widely used, in both the human and potentially the veterinary market, not only for multi-cancer early detection but also the detection of Minimal Residual Disease.
"We believe this represents a significant commercial opportunity with a Total Addressable Market on an annualized basis of approximately
"We are in active discussions with several large liquid biopsy and diagnostic companies to accelerate the development and launch of this technology as soon as possible."
The updated paper should be available on the preprint service
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About Volition
Volition is a multi-national company focused on advancing the science of epigenetics. Volition is dedicated to saving lives and improving outcomes for people and animals with life-altering diseases through earlier detection, as well as disease and treatment monitoring.
Through its subsidiaries, Volition is developing and commercializing simple, easy to use, cost-effective blood tests to help detect and monitor a range of diseases, including some cancers and diseases associated with NETosis, such as sepsis. Early detection and monitoring have the potential not only to prolong the life of patients, but also to improve their quality of life.
Volition's research and development activities are centered in
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