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Diagnostics Omics, Precision medicine, Clinical care, Oncology

Serving China’s Breast Cancer Community

Breast cancer is a significant health burden in China, affecting roughly 300,000 women each year (1). As the country’s population grows, this number will continue to rise, fueled in part by advancements in screening technologies that help diagnose breast cancer earlier. As such, the markets for diagnostic testing and newly developed treatments are rapidly growing to meet this new demand.

Genomic testing will play an important role in China, helping to guide treatment decisions by providing unique insights into the biology of a patient’s cancer and more clarity on its risk of recurrence. Traditionally, physicians have based treatment decisions on the clinical pathological factors of a tumor – so patients with clinically high-risk cancers, including large tumor size, high grade, or lymph node positivity, usually receive chemotherapy. However, recent research from the landmark MINDACT trial (2) has shown that almost half of these clinically high-risk women actually have a low genomic risk of their cancer’s returning and can safely forgo chemotherapy.

In the US and Europe, multiple genomic tests that predict breast cancer recurrence risk are already on the market. However, servicing the Chinese market remains challenging because of laws that prevent the export of biological samples outside of China.

Physicians in China can send patient samples to local hospitals and laboratories to be processed and analyzed using genomic assays or kits that can be run on their own equipment.

One answer to this roadblock is to transition from traditional centralized testing to a decentralized system. This way, physicians in China can send patient samples to local hospitals and laboratories to be processed and analyzed using genomic assays or kits that can be run on their own equipment. The country’s first decentralized breast cancer genomic testing platform has recently been launched, so early-stage breast cancer patients will now have access to clinically validated, prospectively proven tests for both molecular subtyping and risk of recurrence, allowing them both tailored treatment and peace of mind.

The model may be applicable in other countries with similar restrictions around exporting human tissue, as well as those countries that lack government reimbursement for testing done outside the country. Although the reasons behind the need for decentralized testing are fundamentally different, it’s clear that several markets would benefit from a localized processing solution.

At the moment, the availability of genomic testing in China is limited. With the increase in breast cancer screening, though, more women are being diagnosed earlier. Many of these women will have early-stage cancer and won’t require aggressive treatment but, without access to genomic testing, physicians and care teams are basing treatment decisions on clinical factors alone – and potentially administering chemotherapy to patients who might not need it. Ultimately, access to decentralized genomic tests in China will provide patients and their physicians valuable information – beyond just clinical risk factors – so that they can confidently make personalized treatment decisions.

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  1. TT Zuo et al., “Female breast cancer incidence and mortality in China, 2013”, Thorac Cancer, 8, 214–218 (2017). PMID: 28296260.
  2. F Cardoso et al., “70-gene signature as an aid to treatment decisions in early-stage breast cancer”, N Engl J Med, 375, 717–729 (2016). PMID: 27557300.
About the Author
Franklin Libenson

Senior Vice President of Strategic Marketing and Market Development at Agendia, Inc., Irvine, USA.

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