In 2020, the FDA granted its first approval to a comprehensive liquid biopsy, potentially representing a paradigm shift towards using liquid biopsies upfront as an easier, safer, faster, and more effective tool for diagnosing cancer patients than traditional invasive tissue biopsies.
The company behind the Guardant360® CDx test, Guardant Health, is looking to leverage this landmark decision globally, and is basing its operations for the vast Asia, Middle East, and Africa (AMEA) region out of Singapore. First established in 2018, Guardant Health AMEA is a 50/50 joint venture between Guardant Health Inc. of the US and Japanese SoftBank with an initial investment of USD 50 million from both parties.
Oncologists’ experience levels across the region vary widely. There is a need for them to be educated that comprehensive genomic profiling is a must for advanced cancer patients
Explaining the significance of this region to the firm, AMEA CEO Simranjit Singh explains, “Guardant Health has been very innovative in creating this structure and doing it as a joint venture. Most other diagnostic companies see AMEA as almost an afterthought, with less than 10 percent of revenues coming from outside of Europe and the US. However, Guardant’s founders, along with SoftBank, understand the heterogeneity of the region and the need for a different focus, localisation, and becoming embedded here.”
Singh continues, “Asia Pacific has the largest cancer burden and highest cancer mortality rates in the world, so the need is there, meaning there is an enormous opportunity for growth. A dedicated regional strategy and the flexibility to localise solutions is, therefore, key to success.”
Guardant products are already being used in Asia, and Singh has high hopes that the FDA approval can be leveraged in the company’s ambitious expansion plans. “We are in a unique position because our technology is so novel and innovative that many of the regulatory pathways are not yet established,” he exclaims.
“In the US, there is a specific next generation sequencing (NGS) in-vitro diagnostics (IVD) pathway. NGS requires a centralised model, unlike traditional IVD. Most Asian markets see the FDA as a credible regulatory agency, and therefore despite not having an approval pathway for them, several countries have placed their trust in the FDA approval and brought the tests to their home markets… Regulators are in a difficult position and still coming to understand how to define these new technologies. Greater alignment with the US does seem to be the most beneficial way forward and we will increasingly see greater pathway harmonisation across regions.”
In addition to the creation of regulatory pathways, Singh sees education as another crucial element in any future success. “Oncologists’ experience levels across the region vary widely. There is a need for them to be educated that comprehensive genomic profiling is a must for advanced cancer patients. At its core, cancer is a genomic disease and with so many biomarkers, genomic alterations, and mutations driving it. Without comprehensive genomic profiling, effective therapies may be missed.”
A final consideration is access to medicines. “Ultimately, there is no point doing the genomic profiling if the appropriate medicine or therapy is inaccessible,” sighs Singh. “This ties into the question of value-based reimbursement; moving away from a narrow focus on costs alone and ensuring that money is only spent on therapies which have the potential to be effective for patients.”