The company’s BioCaptor technology, developed from the research led by Board members Tim Aitman and Mark Bradley, has seen a number of important technical advances in the last nine months. These have led to highly significant and clinically relevant improvements in capture efficiency, in terms of both the quality and quantity of cfDNA that the BioCaptor is able to collect. The pre-clinical version of the BioCaptor was, on average, able to collect 345ng of cfDNA per yield, significantly higher than quantities of cfDNA recovered from a conventional venous blood draw, which can be as much as 100 times less. The latest developments for the clinical version of the BioCaptor indicate a further significant enhancement in yield over the pre-clinical device.
Lower quantities of cfDNA obtained from a blood draw often require amplification and ultradeep sequencing for liquid biopsy testing, decreasing assay sensitivity and accuracy and limiting the type and stage of cancers that are amenable to existing liquid biopsy testing.
The improved ability to capture high quality and quantity cfDNA by the BioCaptor will help realise the full potential of liquid biopsy and expand the number of patients who can benefit from this approach to cancer management. The BioCaptor has the potential to enable earlier and more accurate diagnosis of cancers, without the need for invasive physical biopsy of the tumour. This will enhance clinical data collection and the ability to diagnose and monitor patients during or post treatment, to track remission and to help direct therapy.
Alongside the technical improvements that have been made to the device, significant progress in manufacturing has also been made. Furthermore, BIOCAPTIVA has amassed considerable preclinical data, including trialing the technology in pigs, which provide a model which closely resembles humans. These data demonstrate the BioCaptor’s safety in relation to liver and kidney function, blood biochemistry and haemocompatibility.
BIOCAPTIVA plans to begin the first in human trials with the BioCaptor in 2022. Ahead of this key milestone, the company has entered into a partnership with Mi3 Medical Intelligence, an expert medical device design, development and manufacturing company. The partnership seeks to develop the technology to manufacture the BioCaptor at a commercially viable scale to the required manufacturing standards.
(eTN): Liquid Biopsy: New Update for Cancer Management | re-post license | post content
