Non-Small Cell Lung Cancer

In August of 2011, Abbott launched the Vysis ALK Break Apart FISH Probe Kit, for use with Pfizer's XALKORI® (crizotinib) ALK-inhibitor, to identify the approximately 3-5% of Non-small Cell Lung Cancer (NSCLC) patients with the ALK gene rearrangement. This collaboration was a breakthrough in the advancement of companion diagnostics in that it was designed to tailor treatment to a patient’s specific genetic profile. Since the U.S. launch, the product has been made available in more than 70 countries,  providing patients like Richard Heimler, a 10-year NSCLC survivor, an opportunity for better treatment outcomes. 

Worldwide, approximately 1.8 million people are diagnosed with lung cancer annually,1 accounting for 13% of all cancers. Of these patients, roughly 85% to 90% have non-small cell lung cancer (NSCLC).2

Abbott’s Vysis ALK – the first FDA approved test for identification of ALK gene rearrangements:

  • 2014 NCCN guidelines upgraded ALK testing to highest recommendation and Vysis ALK listed in CAP/IASLC/AMP NSCLC guidelines.

  • FISH testing alone for ALK has been found to be more cost effective than IHC testing alone.*

  • Vysis ALK is the global clinical trial test used to identify patients for XALKORI® (crizotinib) treatment in Phase II and III clinical trials.

*Lee et al. Testing for anaplastic lymphoma kinase rearrangement to target crizotinib therapy: oncology, pathology and health economics perspectives. Expert Rev. Anticancer Ther. 13(5), (2013)

Vysis ALK Break Apart FISH Probe Kit
Intended Use: The Vysis ALK Break Apart FISH Probe Kit is a test to detect rearrangements involving the ALK gene in tissue samples from non-small cell lung cancer (NSCLC) patients to aid in identifying those patients eligible for treatment with XALKORI ® (crizotinib). 

Limitations: The clinical interpretation of any test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results. 
Rx only
For In Vitro Diagnostic Use

Click here for Europe, Asia, Latin America and other regional product information. 

Click here for U.S. product information. 






Breast Cancer

About 20-25% of the 1,200,000 women worldwide diagnosed each year with breast cancer have amplification of the HER-2 gene. Detection of HER-2 amplification is important in the diagnosis, prognosis, selection of appropriate therapy and prediction of therapeutic outcome in certain cancers.3 Since its approval in 2001, the targeted therapy, Herceptin®, has been improving the odds for HER-2 positive patients like Roseann Kolb

HER-2 amplification and subsequent overexpression of the gene product have emerged as a key prognostic and therapeutic marker in breast cancer. Amplification of this gene is found to be associated with rapid proliferation, shorter disease-free survival and poorer overall survival in both node-negative and node-positive ductal breast cancers. With the advent of monoclonal targeted therapies such as Herceptin® (Trastuzumab), accurate HER-2 assessment is a critical component in determining appropriate therapy selection. Both the National Comprehensive Cancer Network (NCCN®) and the American Society of Clinical Oncology (ASCO®) recommend HER-2 assessment for all invasive breast cancers.

Abbott’s PathVysion®  HER-2 DNA FISH Probe Kit is a precise test that provides clinicians with accurate and reliable HER-2 status information that is used to make critical decisions about therapy.

PathVysion® is one of the preferred tests for assessing HER-2 status:3

  • FISH is considered the gold standard for HER-2 testing.3,4,5
  • Studies indicate FISH to accurately and reproducibly assess tumors for HER-2 status.6
  • PathVysion exhibits better concordance than IHC between local and central laboratories.3
  • The Chromosome 17 probe acts as an internal control and corrects for polysomy (identifies gene amplification versus chromosome 17 polysomy) and nuclear truncation.3
  • FDA approved automated result scanning is available for PathVysion**
  • Abbott Molecular is the clear leader in FISH technology***

** Abbott AutoVysion approved Oct., 2004, Bioview Duet approved Oct. 2008, Ikonisys oncoFISH her2 approved Oct., 2008

*** First FDA approval FISH test, number 1 global sales, still under US patent protection for FISH technology 

PathVysion direct labeled FISH probes yield definitive results at the molecular level. The test uses fluorescent probes to "paint" the HER-2 genes in the tumor cell nucleus, to see if the number of gene copies is normal or not. Interpretation is objective - results are obtained by counting the fluorescent signals (dots). In addition, because this test measures genetic material, which is very stable, tissue preparation has very little effect on test outcome.

PathVysion HER-2 DNA Probe Kit
Intended Use:
 The Vysis PathVysion HER-2 DNA Probe Kit is a test to detect amplification of the HER-2/neu gene in tissue samples from breast cancer patients to aid in determining and identifying those patients eligible for treatment with HERCEPTIN®. 
Limitations: The clinical interpretation of any test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results. 
Rx only
For In Vitro Diagnostic Use 

Click here for Europe, Asia, Latin America and other regional product information.  

Click here for U.S. product information. 

1.     Navada S, Lai P, Schwartz AG, Kalemkerian GP. Temporal trends in small cell lung cancer: analysis of the national Surveillance Epidemiology and
        End-Results (SEER) database [abstract 7082] J Clin Oncol. 2006;24(18S) suppl:384S.


2.     Sher T, Dy GK, Adjei AA. Small cell lung cancer. Mayo Clin Proc. 2008;83(3):355-367.

3.     Sauter G, et al. Guidelines for Human Epidermal Growth Factor Receptor 2 Testing: Biologic and Methodologic Considerations. J Clin Oncol 27:1323-1333,             2009. 
4.     Mass R, et al. Evaluation of Clinical Outcomes According to HER-2 Detection by Fluorescence in situ Hybridization in Women with Metastatic Breast Cancer           Treated with Trastuzumab. Clinical Breast Cancer, vol 6, No. 3, 240-246, 2005. 
5.     Allison M, The HER2 testing conundrum. Nature Biotechnology 28 (2): 117-119, 2010.
6.     Press M, et al. Diagnostic Evaluation of Her-2 as a Molecular Target: An Assessment of Accuracy and Reproducibility of Laboratory Testing in Large,                       Prospective Randomized Clinical Trials, Clinical Cancer Research 2005; 11(18) September 15, 2005.