Rhythm upbeat after putting next-gen bowel cancer test kit through its paces

Rhythm has successfully completed verification and preliminary validation of second-generation ColoSTAT beta assay kits, a simple blood test for early detection of bowel cancer.

Rhythm’s ColoSTAT bowel cancer blood test is now optimised for routine lab use. Pic: Getty Images.

• Rhythm successfully completes verification and validation of second-generation ColoSTAT beta assay kits

• Validation confirms required performance for commercialisation of simple blood test to detect bowel cancer in symptomatic patients

• ColoSTAT now optimised for routine lab use with significant improvements in turnaround times

 

Special Report: Rhythm Biosciences has announced the successful completion of verification and preliminary validation of its second-generation ColoSTAT Beta assay kits, – a simple blood test for the early detection of bowel cancer.

Transformative, predictive cancer diagnostics technology company Rhythm Biosciences (ASX:RHY) has released results from completion of the ColoSTAT Beta kit verification and preliminary validation.

Building on previous reports on the alpha kit, Rhythm said the new findings stem from analysis of high-quality assay kits using banked patient samples.

Extensive verification testing was successfully completed by Rhythm and its development partner, Quansys, generating ~23,000 data points to evaluate a variety of variables including inter and intraplate precision, interference and detection limits.

Rhythm said more than 96% of the tests conducted met the performance targets for the test to be usable in real-world (operational) settings.

The remaining 4% which did not meet the performance targets will be addressed in the final manufactured product.

Rhythm said validation of the beta assay was completed using banked patient samples and performance was successfully assessed in two ways.

Firstly, the test was assessed for analytical variables including precision, reliability and robustness compared to customer needs.

The technical performance of the second generation, multiplexed ColoSTAT assay was substantially improved on all these measures compared to the alpha kit.

Secondly it was established that the beta assay met the performance required to meet or exceed the proposed clinical use as a triage test for patients symptomatic for bowel disease.

Reasons for ColosSTAT redesign

ColoSTAT is a simple, minimally invasive blood test for those currently unwilling or unable to use traditional screening methods for detection of colorectal (bowel) cancer, which is the second leading cause of cancer deaths globally but curable if diagnosed early. It detects specific protein biomarkers in blood that indicate likelihood of colorectal (bowel) cancer.

Rhythm said the primary performance objectives of redesign of the assay from a single-plex into a multiplex format were to:

1. Simplify completion of the test for a routine laboratory
2. Reduce turnaround times (TAT)
3. Improve the quality and performance of the assay
4. Reduce overall cost of goods for the assay

‘Stable and reliable’ blood test to detect bowel cancer

Following extensive testing of its second generation ColoSTAT, Rhythm is confident it has now established a robust and reliable bowel cancer blood test.

The company said it has a clearly defined standard operating procedure, significantly reducing hands-on time, improving throughput and shortening turnaround times.

The next step involves transfer of the beta kit to production by Quansys to produce pilot kits, followed by final testing with an independent set of clinical samples.

Rhythm will then be able to make ColoSTAT commercially available via its commercial laboratory following National Association of Testing Authorities (NATA) Australia accreditation or through partner laboratories, using their own accreditation.

Managing director and CEO Dr David Atkins said performance of the ColoSTAT test was now at a level required to meet the needs for the initial intended use.

“This is the first time the company has had a truly stable and reliable, simple to use ColoSTAT assay with demonstrated performance,” Atkins emphasised.

“We are excited to confidently advance to our final testing phase.”

This article was developed in collaboration with Rhythm Biosciences, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.