Launched in 2010 with a $25 million Series A financing led by Third Rock Ventures, Foundation Medicine released its first commercial assay called FoundationOne in 2012. The company develops, manufactures, and sells genomic profiling assays based on next-generation sequencing technology for solid tumours, hematologic malignancies, and sarcomas. In December 2017, the company’s assay FoundationOne CDx received approval from the US Food and Drug Administration (FDA).
Foundation Medicine was subsequently acquired by Roche, a Swiss multinational healthcare company in June 2018. Through an email interview, MobiHealth News had the opportunity to learn from Dr. James Creeden, Global Medical Director of Foundation Medicine as he shared his thoughts on precision oncology as well as the company’s plans for the Asia Pacific market.
Could you share with us more about your role as the Global Medical Director of Foundation Medicine?
My role is focused on supporting our customers and research partners outside the US. Together with the US Medical Director and our Directors of Clinical Development, I work with our Chief Medical Officer to guide Foundation Medicine’s trial strategy, medical education efforts and research partnerships, while also supporting our customers’ requests for more information on their genomic profiling results.
Precision oncology is defined as the molecular profiling of tumours to identify targetable alterations and has entered mainstream medical practice. What are your observations in the trends and developments of precision oncology in the next few years?
Precision oncology is about bringing the right medicines to the right patient at the right time, so they can have the best chance to benefit from those medicines. Comprehensive genomic profiling (CGP) is a critical part of helping to guide precision oncology by informing treatment decisions based on the genomic information of a person’s tumour.
And I think precision oncology goes further than just testing for known genomic alterations and treating our patients with the medicines available today: if we limited ourselves to that approach, we would still only be testing for HER2 and EGFR. Foundation Medicine’s broad testing approach has created one of the world’s largest database of cancer genomic profiles, which has been used to identify new targets for drug development and companion diagnostic tests to help predict who is likely to respond to those medicines. FoundationOne CDx, our flagship tissue-based test, is now FDA approved as a companion diagnostic (the highest level of clinical validation) for 17 different therapies across five tumour types. This means many more opportunities for patients to benefit from targeted therapy.
Having worked in China for a few years as the Asia-Pacific Regional Medical Director for Roche Foundation Medicine, what kind of opportunities do you see for genomic profiling services within China and more broadly, in the Asia Pacific region?
Many patients in the Asia Pacific region have cancers that can benefit from precision oncology. For example, many more cancer patients in China, and Asia more broadly, have mutations in the EGFR and ALK genes in their tumours, and these mutations predict response to several targeted therapies available today. As we study more cancer patients in Asia with broad genomic profiling techniques, we expect that we may identify more ways that cancer patients in Asia respond differently than those in other regions.
What are some of the challenges and opportunities of working with healthcare regulatory authorities in the region, especially where developments in genomic profiling and diagnostics may be quite nascent?
I think there are lots of opportunities here in Asia Pacific. For example, we’ve interacted with the Health Sciences Authority in Singapore, and they have just come up with a draft guidance on genomic testing. The opportunities lie in how we can have a conversation with the relevant authorities prior to official guidance, referencing the FDA in clinical-grade validation of NGS testing, for the local authorities to have a better sense of how they would want to draft local guidelines on genomic testing. It is critical for local regulatory agencies to regulate genomic testing standards, to ensure that cancer patients are accurately diagnosed and adequately treated.
What are Foundation Medicine’s plans and focus for Singapore and the Asia Pacific region?
The Asia Pacific region, home to 60% of the world’s population, is ageing at an unprecedented rate. According to the United Nations’ Economic and Social Commission for Asia and the Pacific (ESCAP), the proportion of the population 60 years and older will grow from 12.4% in 2016 to more than 25% by 2050. Certainly cancer, as an age-related disease, is becoming a more prevalent in this region. In Singapore for example, at least 1 in 3 Singaporeans will be diagnosed with cancer at some point in their life, and by 2030 the number of Singaporeans diagnosed each year is expected to triple compared to 2012.
Roche Foundation Medicine is committed to continuously innovate on our test offerings to ensure that doctors here get the right information needed to treat and extend patients’ lives. With the recent launch of the FoundationOne CDx in Singapore, and gradually to other markets in the region, we believe we can provide the same level of service and testing value to physicians to provide the promise of precision medicine, which ultimately drives better outcomes for all patients.
A complementary aspect to this is patient access – Foundation Medicine tests need to be available at all major cancer centres as an option to prescribe, and be affordable to patients who need the tests. Roche Foundation Medicine is committed to ensuring that patients who need a Foundation Medicine test get access to it, and has launched Patient Support Programmes in many parts of the world, including Singapore.