VENTANA ALK (D5F3) CDx Assay

Improving efficiency and patient quality of life by detecting the ALK protein that is the target of therapy, and providing timely results at a low cost

VENTANA ALK (D5F3) CDx Assay
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ALK (D5F3) 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 FNA to predict tumor response and survival to crizotinib for advanced NSCLC patients.” 7

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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 ALK (D5F3) Assay stained with OptiView DAB Detection and Amplification (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 benefitting from treatment with XALKORI, ZYKADIA or ALECENSA.

References

 

  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. ALECENSA (alectinib) [package insert], San Francisco, CA: Genentech; 2017.
  5. 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.
  6. 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.
  7. 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.