26 November 2018 | News
Guardant Health AMEA will scale commercialisation of its liquid biopsy test, the Guardant360(R) assay, in the region
Guardant Health AMEA today announces the launch of its Asia, Middle East and Africa headquarters in Singapore with the goal of addressing the unmet medical need in cancer management by leveraging comprehensive genomic profiling liquid biopsy tests and big data analytics.
Its flagship product, Guardant360, first introduced in 2014, has been ordered more than 70,000 times to help inform which therapy may be effective for advanced stage cancer patients with solid tumours. It has been reviewed by more than 80 peer-reviewed publications, which address its analytical validity, clinical validity, and clinical utility in multiple tumour types, and used by 40+ biopharma companies.
Guardant Health AMEA expands commercial footprint in AMEA; and is conducting clinical studies in Asian patient population
Guardant Health AMEA is currently offering Guardant360 to clinical customers for assisting with treatment selection in advanced cancers and has already established distributorships in key markets including Southeast Asia, South Korea, Hong Kong, Taiwan, India, New Zealand, Middle East and Israel.
The Guardant360 assay received breakthrough device designation from the US FDA earlier this year. FDA approval, if and when obtained, is expected to further help accelerate commercial adoption of the test internationally. The company has also established an office in Japan and its growing team comprises expertise in medical affairs, regulatory affairs, business development, bioinformatics, lab operations and sales.
Clinical studies are also underway to generate relevant data specific to Asian patient population. The company is collaborating with the National Cancer East Network (NCCE) SCRUM Japan in two nationwide genomic screening networks, GI-SCREEN and LC-SCRUM Japan, using Guardant360 to match patients to approved or experimental therapies in clinical trials. Guardant Health AMEA has also recently published the first cohort study data on Chinese advanced non-small cell lung cancer patients that received comprehensive liquid biopsy test.