What You Ought to Know:
– C2i Genomics, a most cancers intelligence firm launches its C2inform minimal residual illness (MRD) check throughout Europe, after acquiring CE-IVD marking within the EU, UK and Switzerland. The corporate additionally introduced the completion of a number of scientific trials throughout the globe, together with main most cancers facilities in Europe, U.S. and Singapore.
– The brand new scientific knowledge will likely be introduced on the 2022 American Affiliation for Most cancers Analysis (AACR) annual assembly in New Orleans, Louisiana subsequent week. C2inform is the primary CE Marked software-as-a-medical-device MRD check and will likely be accessible in nations accepting the CE Mark. The check offers a streamlined course of for in-house use by any pathology lab and genomic most cancers lab in order that testing may be provided nearer to the affected person.
How It Works
C2inform check works by making use of whole-genome sequencing and synthetic intelligence to only a 3-4mL blood pattern to assist speedy and correct detection of most cancers, monitoring of illness development and analysis of therapeutic efficacy. The check allows knowledgeable and well timed personalised remedy choices and helps the event of simpler most cancers therapies by means of pharma drug growth partnerships. The check requires considerably lowered lab operation complexity, eliminates the necessity to develop a patient-specific assay, and gives a speedy and excessive throughput resolution for most cancers sufferers throughout the EU.
This European regulatory certification signifies C2inform’s conformity with excessive security, well being, and environmental safety requirements and permits for business sale to most cancers diagnostic labs that require CE Marking. The CE Mark is a prerequisite for reimbursement of diagnostic assessments by well being authorities, and in some European nations, it’s required earlier than laboratories can use a brand new testing methodology. Early adopters embrace a number of main most cancers facilities in Denmark, Switzerland, France and UK, and an trade partnership with OncoDNA, a genomic and theranostic firm that was introduced as a strategic accomplice of C2i Genomics in early 2022.