Recently, Thermo Fisher Scientific’s Oncomine DX Target received FDA approval, becomingThe First Companion Diagnostic Test Based on Next-Generation Sequencing (NGS) Technology Capable of Simultaneously Detecting Biomarkers Associated with Three FDA-Approved Therapies for Non-Small Cell Lung Cancer (NSCLC). This test will significantly accelerate the process for physicians to select treatment regimens for cancer patients.
Oncomine DX Target can simultaneously detect 23 gene mutations associated with NSCLC. Based on the test analysis results, it can be determined whether patients are suitable for the following targeted therapies: targeting EGFR L858R mutation and exon 19 deletionIressa (gefitinib), targeting the BRAF V600E mutationDabrafenib + TrametinibCombination Therapy, and TargetingROS1FusedCrizotinib。
▲ Thermo Fisher Scientific’s Oncomine Dx Target companion diagnostic test, run on the Ion PGM Dx sequencing platform (Image source: prnewswire)
Lung cancer is one of the cancers with the highest mortality rates worldwide, and non-small cell lung cancer (NSCLC) accounts for 85% of all lung cancer cases. With advances in medicine, various targeted therapies for treating NSCLC have been developed and approved by the FDA; however, not all NSCLC patients benefit from these treatments. Therefore, they need to undergo companion diagnostic testing to determine which targeted therapy is most effective for their tumors. However,Previous companion diagnostic tests could only detect one biomarker at a time., the process of identifying the most suitable targeted therapy for a patient may take several weeks. This delay of several weeks can have a significant impact on the patient's condition and treatment outcomes.
Oncomine DX Target is a companion diagnostic test co-developed by Thermo Fisher Scientific, Novartis, and Pfizer. It is based on Thermo Fisher’s Ion AmpliSeq technology and requires only10 ngNucleic acids obtained from tumor tissue samples can simultaneously detect multiple gene mutation biomarkers. This test can reduce the time to identify targeted therapies suitable for patients.From Weeks to Days。
LabCorp, NeoGenomics, and Cancer Genetics have become the first laboratories to offer the Oncomine Dx Target Test. This assay runs on Thermo Fisher Scientific’s Ion PGM Dx Sequencing Platform and can detect formalin-fixed, paraffin-embedded(FFPE) tumor tissue samples。
“Time is life for patients with non-small cell lung cancer, and every second counts,” said Dr. Joydeep Goswami, President of Clinical NGS and Oncology at Thermo Fisher Scientific. “The Oncomine Dx Target Test helps oncologists rapidly identify the optimal targeted therapies, improve patient outcomes, and reduce the cost of targeted therapy.”
“The support that the Oncomine Dx Target Test provides to physicians in companion diagnostics is likely to continue expanding in the future,” added Dr. Goswami. “Thermo Fisher Scientific has collaborated with multiple pharmaceutical companies to apply NGS testing panels to targeted therapies for other cancer types approved by the FDA. Expanding the information available for clinical decision-making is part of our company’s efforts to help customers achieve precision medicine.”
References:
[1] FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple Non-Small Cell Lung Cancer Therapies
[2] Oncomine Dx Target Test