Rhythm Biosciences (ASX:RHY) has successfully maintained ISO certification to the International Standard for In-Vitro Diagnostics and Medical Devices (ISO 13485:2016) for five consecutive years.
The transformative, predictive cancer diagnostics technology company says this is a critical component of its commercial and market entry strategies, as it supports regulatory approval processes and gives confidence in the market and from partners for their operational credibility.
Rhythm Biosciences are currently developing ColoSTAT®, a simple blood test for the detection of colorectal cancer, aimed at global mass market screening.
The test has the potential to reduce morbidity and mortality rates and healthcare costs associated with colorectal cancer by increasing current screening rates, and the global addressable population is over 800 million people.