Commercially available in select EU countries, the non-invasive test is based on real-time PCR-based multiplex detection of molecular-genetic biomarkers in stool samples

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Marylebone Laboratory introduced the ColoAlert test in the UK. (Credit: Testalize.me on Unsplash)

Molecular genetics diagnostic company Mainz Biomed has announced the launch of its ColoAlert test kit with London-based Marylebone Laboratory for the detection of colorectal cancer (CRC) in the UK.

ColoAlert is Mainz Biomed’s flagship product and is said to be an effective and user-friendly at-home test for colorectal cancer.

Commercially available in select European Union countries, this non-invasive test is based on real-time polymerase chain reaction-based (PCR) multiplex detection of molecular-genetic biomarkers in stool samples.

Under the partnership, Marylebone will introduce the ColoAlert screening kit to its UK and global customer base.

The collaboration aligns with Mainz Biomed’s strategy to fight colorectal cancer and save lives with the help of advanced diagnostics. It also strengthens the company’s global network of recognised laboratory partners.

Mainz Biomed chief commercial officer Darin Leigh said: “With Marylebone, we are pleased that we have found a strong strategic partner in the UK market.

“The organisation is committed to bringing the very best CRC screening solutions to the UK population to reduce the number of late CRC diagnoses, thereby increasing patient survival and reducing the burden of medical treatment.”

The partnership, announced in February 2023, uses the recently expanded footprint of Marylebone in London under the Marylebone Diagnostic Centre brand. The diagnostic centre offers a range of screening and diagnostic testing services.

The laboratory also brings its expertise in next-generation sequencing (NGS) and PCR-based molecular genetic testing, the molecular genetics diagnostic company said.

Marylebone Diagnostic Centre director Thomas Bianchi said: “With our significant experience in both NGS and PCR-based molecular genetic testing, we are thrilled to offer ColoAlert to our UK-based and international customer network.

“Colorectal cancer is the fourth most common cancer in the UK and the third worldwide and ColoAlert’s unique genetic-based solution has the potential to provide a step change in how we’re able to provide life-changing early diagnosis.”

Mainz Biomed is currently conducting the US Food and Drug Administration (FDA)-registration study ReconAAsense to secure regulatory approval for ColoAlert in the US.