Rhythm Biosciences (ASX:RHY) retains fifth consecutive ISO certification for ColoSTAT


  • Rhythm Biosciences (RHY) retains its ISO certification for a fifth consecutive year
  • The certification means Rhythm has met the international standard for in-vitro diagnostics and medical devices for its ColoSTAT blood test product
  • Rhythm says the ISO certification is a “critical component” of its commercial and market entry strategies and validates the company’s quality management systems to deliver its cancer detection technology
  • Rhythm Biosciences is up 0.53 per cent and trading at 95.5 cents at 3:58 pm AEDT

Rhythm Biosciences (RHY) has retained its ISO certification for its ColoSTAT test for a fifth consecutive year.

The certification means Rhythm has met the international standard for in-vitro diagnostics and medical devices for ColoSTAT, its blood test for the detection of colorectal cancer for mass market screening. The test is simple and low-cost and removes the usual unpleasantness or difficulty of standard colonoscopies.

ISO 13485:2016 is the internationally-recognised quality standard to ensure the consistent design, manufacture, and sale of medical devices that are safe for their intended purposes. The certification was conducted by the British Standards Institution.

Rhythm said the ISO certification was a “critical component” of its commercial and market entry strategies, validating the quality management systems Rhythm has maintained over an extended period.

“I am proud of the entire team for their dedication and commitment to the ongoing achievement to maintain certification to the standard,” Rhythm CEO and Managing Director Glenn Gilbert said.

“This is a reflection of the quality and discipline that has been established as we focus on the substantial global opportunity in front of us for our transformative lifesaving cancer detection technology.”

Rhythm Biosciences was up 0.53 per cent and trading at 95.5 cents at 3:58 pm AEDT.


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