VENTANA ALK (D5F3) CDx Assay
Identifying ALK + NSCLC patients for targeted treatment
The VENTANA ALK (D5F3) CDx Assay empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.
US Testing Information
- ALK (D5F3) Assay stained with OptiView DAB Detection and Amplification detects the ALK protein that is the target of therapy
- Clinical guidelines recommend rapid turnaround for earlier targeted therapies
- ALK has comparable sensitivity and specificity relative to FISH
- Make more immediate treatment decisions for advanced NSCLC patients by using the ALK (D5F3) Assay
- XALKORI® (crizotinib) ZYKADIA® and ALECENSA® (alectinib) are clinically effective and FDA approved for the treatment of ALK-positive patients
XALKORI, ZYKADIA and ALECENSA are indicated for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA approved testing method for ALK.1, 3
XALKORI (crizotinib) is indicated for the treatment of patients with ALK positive metastatic NSCLC and other kinases1
ZYKADIA (ceritinib) is indicated for the treatment of patients with ALK-postive metastatic NSCLC who have had no previous treatment, or who have progressed on, or who are intolerant to, crizotinib.3
ALECENSA (alectinib) is indicated for the treatment of patients with ALK-postive metastatic NSCLC who have had no previous treatment, or who have progressed on, or who are intolerant to, crizotinib.7
Clinical guidelines recommend routine testing for genetic mutations in all adenocarcinomas, including ALK EML4 gene rearrangement. Testing is recommended immediately after establishing histology and is required prior to initiating targeted therapy for a patient. The current approved methods for testing include IHC and FISH.
Lung cancer is the most prevalent form of cancer in the world. Each year, more than 1.8 million new cases are diagnosed. Lung cancer also has the highest mortality rate. Five-year survival rates are as low as 18%.
Adenocarcinoma, a subset of NSCLC, is the most common, comprising approximately 40% of all lung disease.4, 5
In one study, van der Wekken et al. “…found that Dichotomous ALK-IHC is superior to ALK-FISH on small biopsies and FNA to predict tumor response and survival to crizotinib for advanced NSCLC patients.” 6
1. XALKORI® (crizotinib) [package insert]. New York, NY: Pfizer; 2012.
2. Ferlay, J., Soerjomataram, I., Ervik, M., Dikshit, R., Eser, S., Mathers, C., Rebelo, M., Parkin, D.M., Forman, D., Bray, F. (2012). GLOBOCAN v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 Lyon, France: International Agency for Research on Cancer; 2013. Available at: http://globocan.iarc.fr (last accessed March 2016).
3. ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2016.
4. World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Lyon, France http://globocan.iarc.fr/ Default.aspx. Accessed August 1, 2014.
5. Lung Cancer Survival Rates and Prognosis. National Cancer Institute at the National Institutes of Health. Bethesda, MD. http://www.cancer.gov/cancertopics/types/lung/cancer-survival-prognosis Accessed August 1, 2014.
6. van der Wekken et al Dichotomous ALK-IHC is a better predictor for ALK inhibition outcome than traditional ALK-FISH in advanced non-small cell lung cancer, Clinical Cancer Research, 2017. Available at http://clincancerres.aacrjournals.org/content/early/2017/02/09/1078-0432. CCR-16-1631.
7. ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech.
ALK (D5F3) Assay and Detection with Amplification vs. FISH
Online training for pathologists – US
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