One of the most powerful tools in the battle to improve cancer treatment is genomics, the study of complex sets of genomes and the role they play in cancer biology. Whilst genetics suggests how inherited traits are passed through the generations or arise through mutation, genomics can tell us how a cancer is likely to respond to treatment.
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Genomic studies and research are being used to develop clinically validated tests that provide the genomic profile of an individual's tumour. This helps to understand whether a patient is likely to benefit from and respond to cancer therapies such as chemotherapy, or whether he or she is more likely to experience a recurrence of their cancer.
Through the use of genomic tests that measure the activity of genes in cancers, useful additional information is obtained where there is uncertainty about the benefit of chemotherapy to help prevent the cancer returning.
A pioneer in genomic testing in breast cancer diagnostics is Genomic Health, founded in 2000 by Randy Scott. Inspired by a friend’s cancer diagnosis, Scott set himself the goal of developing high-value diagnostics to enable more personalised cancer treatment decisions, based on the genomic activity within a patient’s individual tumour.
By 2001, Genomic Health had completed proof-of-concept studies showing that their gene expression tests could be carried out routinely on available tumour tissues. The company opened its worldwide headquarters in Redwood City, California and over the following years the Oncotype DX Breast Recurrence Score® test was introduced into clinical practice in the USA. By 2009 it had been used for over 100,000 breast cancer patients worldwide. In the years after the introduction of the Oncotype DX®test, Genomic Health developed other genomic tests for use in colon cancer and prostate cancer.
The Oncotype DX Breast Recurrence Score
The Oncotype DX Breast Recurrence Score® test was introduced into clinical practice in the UK in 2010 and recommended by the UK’s National Institute for Health and Care Excellence (NICE) in 2013. The Oncotype DX test was approved for funding on the NHS in 2015 and it is now established in UK clinical practice as standard care for patients with lymph node-negative early breast cancer, with whom the benefit of chemotherapy is uncertain (intermediate risk of recurrence of disease). In 2018, NICE renewed its recommendation of the Oncotype DXtest for use in clinical practice to guide chemotherapy treatment decisions, expanding its recommendation from lymph node-negative patients only to include patients with micrometastases, where very small cancer cell deposits have spread to the lymph node (larger than 0.2 mm but no bigger than 2mm)a. The test is unfortunately not yet routinely funded on the NHS for patients diagnosed with lymph node positive breast cancer (cancer cell deposits in 1-3 lymph nodes), but it is available in private practice and funded by all major private health insurers.
The Oncotype DX test is the only test that provides specific information about whether a group of patients will or won’t respond to chemotherapy, correctly identifying both the important minority of early-stage breast cancer patients who will receive substantial treatment benefit and the majority of patients who will not benefit from chemotherapy. The Oncotype DX test is unique in having been validated in multiple clinical trials and more than 1 million people have benefitted from the test worldwide.
Genomic Health now delivers over 500 Oncotype DX Recurrence Score®results per day to more than 90 countries through a centralised clinical laboratory.
The company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring.
a.© NICE 2018 Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. Available from https://www.nice.org.uk/guidance/dg34
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