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).
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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.”
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By GlobalDataGuardant 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 in cancer patients.
Singh added: “Our hope is that this approval will drive clinical adoption of liquid biopsy testing in Singapore and enable more patients to be matched to potentially life-changing precision medicines.”
The Guardant360 CDx test was the first US Food and Drug Administration (FDA) approved blood test for CGP of all solid tumours.
In January this year, the company received approval from the FDA to use the blood test as a companion diagnostic for ORSERDU (elacestrant) in advanced or metastatic breast cancer patients with ESR1 mutations.
The Guardant360 test is FDA-approved as a companion diagnostic test for four targeted therapies for the treatment of NSCLC and one for advanced breast cancer.
It is also approved in Japan for CGP of patients with advanced solid cancers and as a companion diagnostic for Keytruda (pembrolizumab) and Opdivo (nivolumab).
