The Oncomine Dx Target Test is a qualitative in vitro diagnostic test that analyzes genetic material from tumor tissue samples. It helps medical professionals gather specific information about a patient’s cancer.
Role in Personalized Cancer Treatment
The Oncomine Dx Target Test plays a role in advancing personalized cancer treatment, also known as precision medicine. This approach tailors medical care to an individual’s unique genetic makeup and the specific characteristics of their tumor. The test assists in identifying particular genetic changes within a tumor that can influence how it responds to certain therapies.
By uncovering these specific genetic alterations, the test helps oncologists make informed decisions about treatment strategies. It can guide the selection of targeted therapies, which are drugs designed to act on specific molecules involved in cancer growth, or identify eligibility for immunotherapies. This allows for a more focused and potentially more effective treatment plan, moving away from a one-size-fits-all approach.
How the Test Analyzes Genes
The Oncomine Dx Target Test analyzes a patient’s tumor tissue sample, typically obtained from a biopsy. The process begins with the extraction of DNA and RNA from formalin-fixed, paraffin-embedded (FFPE) tumor tissue. These genetic materials are then prepared for analysis using Next-Generation Sequencing (NGS) technology.
NGS allows for the simultaneous examination of many genes, looking for various changes in their sequences. This high-throughput method can detect multiple genetic alterations from a small amount of tissue. The prepared DNA and RNA are processed on a specialized instrument, such as the Ion PGM Dx System, which performs the sequencing reactions.
Genetic Changes Identified
The Oncomine Dx Target Test is designed to detect several types of genetic alterations within cancer cells. These include single-nucleotide variants (SNVs), which are changes in a single DNA building block. It also identifies deletions, where segments of DNA are missing, and insertions, where extra DNA is present.
The test is also capable of detecting gene fusions, which occur when two previously separate genes join together. Additionally, it can identify gene amplifications, where there are too many copies of a particular gene. These genetic changes are significant because they can drive uncontrolled cell growth and influence how a cancer responds to specific treatments. The test can detect 46 cancer driver gene variants.
What Test Results Mean for Patients
The results of the Oncomine Dx Target Test provide oncologists with actionable information to guide patient care. The test report includes findings on companion diagnostic markers, which are genetic alterations directly linked to specific FDA-approved targeted therapies. If a particular alteration is found, it may indicate that a patient could benefit from a specific drug designed to target that change.
For example, the test can identify specific mutations in genes like IDH1 and IDH2 in astrocytoma and oligodendroglioma brain tumors, indicating potential responsiveness to therapies like vorasidenib. The results also highlight other cancer driver analytical-only biomarker results, which can suggest eligibility for participation in clinical trials exploring new treatments. This aims to match patients with the most effective therapies available, potentially improving treatment outcomes and reducing the likelihood of ineffective treatments.