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First FDA Approval for NGS-based Companion Diagnostic

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The companion diagnostics market is growing at an incredible rate1, and is paving the path towards widespread adoption and availability of personalized medicine for a range of diseases. The latest breakthrough in the field saw the first FDA approval of a next-generation sequencing based test for non-small cell lung cancer, the Oncomine Dx Target Test.

To learn about some of the challenges met in reaching this milestone, the advantages the test offers, and how its use can benefit non-small cell lung cancer patients, we spoke to Joydeep Goswami, president of Clinical Next Generation Sequencing and Oncology at Thermo Fisher Scientific

Can you tell us about the Oncomine Dx Target Test?

The Oncomine Dx Target Test is the first FDA-approved, next-generation sequencing (NGS)-based In Vitro Diagnostic for non-small cell lung cancer (NSCLC). It is designed to simultaneously screen patient tumor samples for 23 genes associated with NSCLC. Results from analysis of three of these genes can now be used to identify patients who may be eligible for treatment with one of the following: the combined therapy of Tafinlar® and Mekinist®, XALKORI®, or IRESSA®. Thermo Fisher developed the Oncomine Dx Target Test in collaboration with Novartis and Pfizer.

What advantages does the test have over current methods?

Current molecular testing is performed sequentially – meaning samples are testing one biomarker at a time. This extends the time it takes to get results by weeks, time that most NSCLC patients don’t have to spare. The Oncomine Dx Target Test screens samples for all the genes simultaneously, eliminating the sequential testing approach and returns results in days. This enables oncologists to quickly develop a treatment plan for their patients. Additionally, the Oncomine Dx Target Test is based on Thermo Fisher’s Ion AmpliSeq technology, which enables screening of tumor samples with as little as 10ng of nucleic acid. The ability to return results from such a small amount of tissue is a critical advantage of the test and helps meet a clinical testing need especially when sample is limiting, which is often the case with NSCLC patients. This advantage also prevents the need to perform additional biopsies to retrieve more sample, as can be the case with sequential testing methods.

How will use of the test affect patients?

NSCLC patients with Stage III or IV cancer don’t have time to wait several weeks for their physicians to receive all the necessary genomic information on their tumors to determine the most appropriate treatment plan. Being able to receive the information on their tumors within days enables patients to get on the right drug quickly with the hope that it will lead to better health outcomes. The Oncomine Dx Target Test may also eliminate the trial and error associated with the sequential testing approach. Ultimately getting on the right treatment the first time could help improve the health of NSCLC patients. It also could help eliminate the cost of treatment to the patient and to the healthcare system that may occur when patients are placed on the wrong or ineffective therapies. Finally, the test can eliminate the need to perform additional biopsies in cases when sample material is depleted, particularly when sequential testing is performed.

What challenges needed to be overcome along the road to obtaining FDA approval?

The bar to reach FDA approval for an IVD is extremely high, and this was especially the case given that it was the first time an NGS-based companion diagnostic was being submitted for premarket approval. The submission documents for the Oncomine Dx Target Test alone contained more than 220,000 pages of data. The process was a major learning exercise for all involved – Thermo Fisher, its pharma partners – Pfizer and Novartis – and the FDA.

How important will companion diagnostics be in the future of healthcare?

With the approval of more targeted therapies, it is very likely that the FDA will require them to be paired with the right companion diagnostics to ensure that the right drug gets to the right patient.  Specifically for cancer, companion diagnostics will require the assessments of ever more potential actionable mutations within the tumor, a task that NGS-panel-based testing is best suited to handle.  For patients and clinicians, this is a major improvement in the quality of timely care and outcomes.  From an overall cost effectiveness to healthcare systems, a comprehensive companion diagnostic test that costs a few thousand dollars, but can help select a targeted therapy, will be essential.  Advances in diagnostics such as liquid biopsies can further improve patient outcomes and costs by removing the need for solid tumor biopsies and potentially be able to detect tumor occurrences and recurrences earlier. 

Joydeep Goswami was speaking to Anna MacDonald, Editor for Technology Networks.