VENTANA® ALK (D5F3) CDx Assay
Use left and right arrow keys to scroll between the tabs
Identifying ALK+ NSCLC patients for targeted treatment
The VENTANA ALK (D5F3) CDx Assay empowers your lab to provide timely results with a 4.5-hour run time using fully automated, ready-to-use reagents.
Intended use
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffinembedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT, BenchMark ULTRA or BenchMark ULTRA PLUS instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), ALECENSA® (alectinib) or LORBRENA® (lorlatinib).1-4
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.
Benefits of IHC testing
Clinical guidelines recommend rapid turnaround for earlier initiation of targeted therapies.5
The FDA approved VENTANA ALK (D5F3) Assay, stained with OptiView DAB Detection and Amplification, delivers same-day results–a 4.5-hour, fully automated test that can be run alongside routine IHC testing to meet CAP/IASLC/AMP guidelines for testing lung cancer patients.7
Faster treatment decisions can be made for advanced NSCLC patients using the VENTANA ALK (D5F3) Assay.
Studies show the assay is a sensitive and specific method for determining ALK status, offering a better alternative to ALK FISH. Reports also show that some ALK IHC-positive, FISH-negative patients benefit from ALK-targeted therapy with XALKORI.8-12
In external quality assurance (EQA) testing, the VENTANA ALK (D5F3) Assay scored highest among ready-to-use antibodies for demonstrating ALK rearrangement.13
Available therapies for ALK-positive metastatic NSCLC
Multiple FDA-approved therapies are available for the treatment of patients with ALK-positive metastatic NSCLC, as detected by an FDA-approved test. These include:
XALKORI® (crizotinib): Indicated for the treatment of patients with ALK-positive metastatic NSCLC and other kinases.1
ZYKADIA® (ceritinib): Indicated for the treatment of patients with ALK-positive metastatic NSCLC.3
ALECENSA® (alectinib): Indicated for the treatment of patients with ALK-positive NSCLC
as adjuvant treatment following tumor resection (tumors ≥4 cm or node-positive), or
for metastatic disease.7
LORBRENA® (lorlatinib): Indicated for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on:
crizotinib and at least one other ALK inhibitor for metastatic disease; or
alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.12
Technical benefits of IHC testing
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 LORBRENA8-12
Shown: Comparison of VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp vs. FISH testing for determining ALK status
Would you like to know more about the VENTANA ALK (D5F3) CDx Assay?
Please submit your information in the following form to be contacted by a Roche representative with more details.
VENTANA ALK (D5F3) CDx Assay and detection with amplification vs. FISH
View Full TableVENTANA ALK (D5F3) CDx Assay and detection with amplification vs. FISH
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) CDx Assay with OptiView DAB Detection and Amplification | ALK FISH | |
|---|---|---|
Scoring process |
|
|
| Turnaround times |
|
|
| Brightfield vs. fluorescent staining |
|
|
Testing for lung cancer
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 practice and guidelines for testing includes IHC and FISH.14
With the introduction of targeted therapies that can result in dramatically different outcomes based on subtype, the importance of accurate classification has been amplified.16
Up to 30% of lung biopsies require adjunct IHC testing after morphologic evaluation.15 IHC and, more specifically, key panels of IHC antibodies, provides the necessary complement in the routine diagnosis and subtyping of lung cancer.16
References
- XALKORI® (crizotinib) [package insert], New York, NY: Pfizer; 2012.
- 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: https://globocan.iarc.fr [accessed March 2023].
- ZYKADIA (ceritinib) [package insert], Whippany, NJ: Novartis Pharmaceuticals Corporation 2016.
- ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2017.
- World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Lyon, France https://globocan.iarc.fr [accessed March 2014]
- Lung Cancer Survival Rates and Prognosis. National Cancer Institute at the National Institutes of Health. Bethesda, MD. http://www.cancer.gov [accessed March 2023]
- 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 [accessed March 2023]
- Zhou J, Zhao J, Sun K, Wang B, Wang L, et al. Accurate and Economical Detection of ALK Positive Lung Adenocarcinoma with Semiquantitative Immunohistochemical Screening. PLoS ONE (2014) 9(3): e92828. doi:10.1371/journal.pone.0092828.
- Ling Shan, Fang Lian, Lei Guo, Xin Yang, Jianming Ying and Dongmei Lin. Combination of conventional immunohistochemistry and qRT-PCR to detect ALK rearrangement. Diagnostic Pathology 2014, 9:3. doi:10.1186/1746-1596-9-3.
- Ying, J.; Guo, L.; Qiu, T.; Shan, L.; Ling, Y.; Liu, X.; Lu, N. Diagnostic value of a novel fully automated immunochemistry assay for detection of ALK rearrangement in primary lung adenocarcinoma. Annals of Oncology. 24(10):2589-2593, October 2 Modern Pathology (2013) 26, 1545–1553; doi:10.1038/modpathol.2013.87; published online 7 June 2013.
- Mok T, Peters S, Camidge DR. Patients with ALK IHC-positive/fish-negative NSCLC benefit from ALK TKI treatment: response data from the global ALEX trial. Presented at: the IASLC 18th World Conference on Lung Cancer; October 15-18; Yokohama, Japan. Poster MA 07.01
- LORBRENA (lorlatinb)[package insert], New York, New York: Pfizer; 2020
