Guardant Health secures approval for liquid biopsy test in Singapore

4 months ago 94

The Guardant360 CDx CGP blood test facilitates personalised treatment decisions for patients with advanced solid cancers.

The Guardant360 CDx test collects sample with a routine blood draw and provides CGP results within seven days. Credit: Guardant Health.

Guardant Health has received approval from Singapore’s Health Sciences Authority (HSA) for Guardant360 CDx, a liquid biopsy test for patients with advanced solid cancers.

The minimally invasive test is designed to perform tumour mutation profiling, which is also called comprehensive genomic profiling (CGP).

It was also approved as a companion diagnostic test for TAGRISSO (osimertinib) to treat patients with advanced non-small cell lung cancer (NSCLC) with mutations in epidermal growth factor receptors.

With the approval, Guardant360 CDx became the first HSA-approved blood test for CGP of all solid tumours.

Guardant Health AMEA CEO Simranjit Singh said: “We are delighted to receive regulatory approval from HSA for our Guardant360 CDx test, as it supports the value liquid biopsy brings to oncologists and the patients they treat.

“With a simple blood draw from the patient, the Guardant360 CDx test provides CGP results in approximately seven days from receipt of the blood sample in the laboratory, enabling physicians to make faster treatment decisions compared to tissue biopsies.”

Guardant Health AMEA is working together with National Cancer Centre Singapore and National University Cancer Institute, Singapore to perform several clinical trials using the Guardant360 test.

The collaboration will support efforts to accelerate enrolment in clinical trials by identifying genomic biomarkers...

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