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.
VENTANA ALK (D5F3) CDx Assay
Identifying ALK+ NSCLC patients for targeted treatment
Intended use
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).1,2,3,4
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 targeted therapies5
- The approved VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp is a 41/2-hour, fully automated test to be stained with all other routine IHC testing for sa me-day results and to meet current CAP/IASLC/AMP guidelines for testing patients with lung cancer.7
- More immediate treatment decisions can be made for advanced NSCLC patients by using the VENTANA ALK (D5F3) Assay
- Recent studies indicate that the VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp 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 benefiting from treatment with XALKORI. 8,9,10,11,12
- The VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp scored high in External Quality Assurance testing vs. all other ready-to-use antibodies for demonstration of ALK rearrangement.13
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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) Assay stained with OptiView DAB Detection and Amp 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 benefiting from treatment with XALKORI.8,9,10,11,12
Figure 5. Comparison of VENTANA ALK (D5F3) Assay stained with OptiView DAB Detection and Amp vs. FISH testing for determining ALK status
| VENTANA ALK (D5F3) Assay with OptiView DAB Detection and Amp |
ALK FISH |
|---|---|
Scoring Process
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Scoring Process
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Turnaround time
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Turnaround time
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Brightfield vs. fluorescent staining
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Brightfield vs. fluorescent staining
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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
1. XALKORI® (crizotin ib) [package insert], New York, NY: Pfizer. 2012.
2. ZVKADIA (ceritinib) [package insert], Whi ppany. NJ: Novartis Pharmaceuticals Corporation. 2016.
3. ALECENSA (alectini b) [package insert], San Francisco, CA: Genentech; 2017.
4. LO RB RENA (lorlatinib) [package insert] New York, NY: Pfizer: 2021.
5. Mohammed, N. et al. (2011) 'Rapid disease progression with delay in treatment of non -small-cell lung cancer.' International Journal of Radiation Oncology Biology Physics. 79(2). p. 466-472
6. ESMO international guidelines for ALK testing in NSCLC (updated 2018) Planchardd et al., Annals of Oncology, 2018
7. College of American Pathologists (2017-A). https://www.cap.org/protocols-and-guidelines/current-cap-guidelines. Accessed July 2023.
8. 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.
9. 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 .
10. 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.
11. Selinger CI1, Rogers TM, Russell PA, et al.Testing for ALK rearrangement in lung adenocarcinoma: a multicenter comparison of immunohistochemistry and fluorescent in situ hybridization. Modern Pathology (2013) 26, 1545–1553; doi:10.1038/modpathol.2013.87; published online 7 June 2013.
12. Greta Alì, Agnese Proietti, Serena Pelliccioni, et al. ALK Rearrangement in a Large Series of Consecutive Non–Small Cell Lung Cancers: Comparison Between a New Immunohistochemical Approach and Fluorescent In Situ Hybridization for the Screening of Patients Eligible for Crizotinib Treatment. Arch Pathol Lab Med. 2014 June 2.
13. NordiQC External Quality Assurance in Immunohistochemistry ALK Run 65 2002. https://www.nordiqc.org/epitope.php. Accessed April 24, 2003.
14.Lindeman NI, Cagle PT, Beasley MB et al. Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Journal of Thoracic Oncology. Volume 8(7), July 2013, p 823–859. doi: 10.1097/JTO.0b013e318290868f.
15. Rossi, et al. Subtyping Non-Small Cell Lung Cancer. Int J Surg Pathol. 21:326.2013.
16. Capelozzi, V.L. Role of immunohistochemistry in the diagnosis of lung cancer J Bras Pneumol. 2009;34(4) : 375-382.