Rhythm set to advance bowel cancer test with key accreditation for Genetype

• Rhythm receives reinstatement of NATA accreditation for Genetype risk assessment portfolio
• Genetype is a sophisticated genetic risk assessment testing platform for various diseases
• Reinstatement is a key milestone for securing ColoSTAT accreditation and commercial launch

Special Report: Rhythm Biosciences has secured full reinstatement of accreditation for its Genetype cancer risk assessment assay portfolio with the milestone set to advance its blood test for early detection of bowel cancer ColoSTAT.

Late last year, Rhythm acquired the Genetype testing platform from the administrators of Genetic Technologies (ASX:GTG) with the accreditation suspended following the asset transfer.

However, Rhythm Biosciences (ASX:RHY) has now secured full reinstatement of the accreditation, completing the integration of the Genetype laboratory under the company’s ownership and ensuring continuity of accredited testing services moving forward.

Rhythm said Genetype was a sophisticated genetic risk assessment testing platform that combines clinical, family history and genetic data to provide comprehensive risk assessments for various diseases.

The platform leverages polygenic risk scores and clinical risk factors to generate personalised health insights and help patients and healthcare providers make more informed medical decisions.

The technology allows for risk assessment across multiple conditions including breast cancer, cardiovascular disease, diabetes, colorectal cancer, prostate cancer and melanoma.

Rhythm said the tests were delivered through healthcare providers and genetic counsellors, ensuring appropriate clinical oversight and support for patients receiving their results.

Watch: Inside ColoSTAT’s road to market

Reinstatement crucial for advancing ColoSTAT

Rhythm said the reinstatement was also crucial for advancing the commercialisation strategy of its blood test for early detection of bowel cancer ColoSTAT.

The company said that with an ISO 15189-accredited quality system now under Rhythm’s control, it was well positioned to advance ColoSTAT as an in-house in-vitro diagnostic (IVD).

This remains subject to completing a variation assessment to formally add ColoSTAT as a Rhythm-accredited service.

Once approved,  Rhythm said this would enable the company to deploy ColoSTAT in clinical settings and generate real-world performance data,  a critical step towards Rhythm’s goal of commercialising the test globally as a regulated IVD.

“Reinstating NATA accreditation for Genetype is an important enabler for our plans to scale the clinical availability of this important portfolio of cancer risk assessment assays,” said CEO and managing director Dr David Atkins.  

“Furthermore, this is a significant stepping stone to allow us to offer ColoSTAT as an in-house IVD for the domestic market in the coming months.”

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