Predictive IHC assay
The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.
* VENTANA ALK (D5F3) Assay
Crizotinib, alectinib and lorlatinib are clinically effective and CE Marked 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) 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 crizotinib, ceritinib or alectinib. 8,9,10,11
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
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
| VENTANA ALK (D5F3) Assay with OptiView DAB Detection and Amplification |
ALK FISH |
|
|---|---|---|
Easy to score |
|
|
| Faster turnaround times |
|
|
| Brightfield vs. fluorescent staining |
|
|
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
The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody empowers your lab to provide timely results with a four-and-one-half hour run time using fully automated, ready-to-use reagents.
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (VENTANA anti-ALK (D5F3)) is intended for laboratory use in the detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (NSCLC) tissue stained with the BenchMark IHC/ISH instruments. It is indicated as an aid in identifying patients eligible for treatment with crizotinib, ceritinib, or alectinib or 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.
* VENTANA ALK (D5F3) Assay
Crizotinib, ceritinib and alectinib are clinically effective and 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, 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) 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 crizotinib, ceritinib or alectinib. 8,9,10,11
References
To search for product information for reagents, ancillaries and bulks please visit your local Catalog for Healthcare Professionals in eLabDoc, an eService within dialog.roche.com.
