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[Companion diagnostics with FISH assay (HER2, ALK)]
Abstract:
In recent anti-cancer drug treatment, personalized medicine has become popular with the development of many molecularly-targeted drugs. Companion Diagnostics (CDx) identify and detect biomarkers to predict whether a drug will work or have adverse effects on patients. We developed two CDx with FISH assays, the PathVysion HER-2 DNA Probe Kit and Vysis ALK Break Apart FISH Probe Kit. The PathVysion HER-2 DNA Probe Kit is a test to detect amplification of the HER2 gene in tissue samples from breast cancer patients to aid in determining and identifying patients eligible for treatment with Trastuzumab. The Vysis ALK Break Apart FISH Probe Kit is a test to detect rearrangements involving the ALK gene in tissue samples from non-small cell lung cancer (NSCLC) patients to aid in identifying patients eligible for treatment with Crizotinib. In this article, we review the CDx, focusing on HER2 gene and ALK fusion testing.
Insights
Companion Diagnostics (CDx) are crucial for personalized cancer therapy. This review highlights two FISH assays for HER2 and ALK gene testing, aiding targeted drug selection for breast and lung cancer patients.
Area of Science:
- Oncology
- Molecular Diagnostics
- Personalized Medicine
Background:
- The rise of molecularly-targeted anti-cancer drugs necessitates companion diagnostics (CDx) for effective patient stratification.
- CDx assays identify predictive biomarkers, guiding treatment decisions and minimizing adverse drug reactions.
- Fluorescence In Situ Hybridization (FISH) is a key technology for detecting genetic alterations in cancer.
Purpose of the Study:
- To review the role and application of companion diagnostics in modern cancer therapy.
- To focus on two specific FISH-based CDx assays: HER2 gene amplification and ALK gene rearrangement testing.
- To illustrate how these tests identify patient eligibility for targeted therapies like Trastuzumab and Crizotinib.
Main Methods:
- Development and application of FISH assays for detecting specific genetic biomarkers.
- PathVysion HER-2 DNA Probe Kit for HER2 gene amplification in breast cancer.
- Vysis ALK Break Apart FISH Probe Kit for ALK gene rearrangements in non-small cell lung cancer (NSCLC).
Main Results:
- The HER2 FISH assay identifies breast cancer patients suitable for Trastuzumab treatment.
- The ALK FISH assay identifies NSCLC patients eligible for Crizotinib therapy.
- These CDx assays demonstrate the clinical utility of molecular diagnostics in guiding targeted cancer treatments.
Conclusions:
- Companion diagnostics are integral to personalized oncology, enabling targeted drug selection.
- FISH assays for HER2 and ALK provide essential information for treating specific patient populations.
- Continued development and application of CDx are vital for advancing precision cancer medicine.
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