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.
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.
XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) and LORBRENA® (lorlatinib) are clinically effective and FDA approved for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved testing method for ALK.1,3,7
ALK FISH can present technical challenges in evaluating patient results and offers the potential for false negatives. Recent studies indicate that the VENTANA ALK (D5F3) CDx Assay stained with OptiView DAB Detection and Amplification is sensitive and specific for determination of ALK status, and a better alternative to ALK FISH. There are reports of ALK IHC-positive, FISH-negative patients benefitting from treatment with XALKORI, ZYKADIA, ALECENSA or LORBRENA8,9,10,11,12
Shown: comparison of VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp vs. FISH testing for determining ALK status
| VENTANA ALK (D5F3) CDx Assay with OptiView DAB Detection and Amplification |
ALK FISH |
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Scoring process |
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| Brightfield vs. fluorescent staining |
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In one study, van der Wekken et al. “…found that dichotomous ALK-IHC is superior to ALK-FISH on small biopsies and fine-needle aspirations (FNA) to predict tumor response and survival to crizotinib for patients with advanced NSCLC.”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.5,6
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) or LORBRENA® (lorlatinib).
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.
This product is intended for in vitro diagnostic (IVD) use.
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