Abbott Receives FDA Approval for New Molecular Diagnostic Test for NSCLC

Strategic Insights -

Abbott has received approval from the US Food and Drug Administration (FDA) for a new molecular diagnostic test designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in non-small-cell lung cancer (NSCLC). The new Abbott Vysis ALK Break Apart FISH Probe test is designed to identify ALK-positive NSCLC patients for Pfizer's approved NSCLC therapy, XALKORI (crizotinib). The test uses Abbott's fluorescence in situ hybridization (FISH) technology to detect rearrangements of the ALK gene on the 2p23 chromosome. This diagnostic test will help clinicians identify patients more likely to benefit from the new therapy, changing clinical practice for the diagnosis and treatment of patients with NSCLC.

Key Takeaways:

  • The Abbott Vysis ALK Break Apart FISH Probe test is the first FDA-approved diagnostic test for detecting ALK rearrangements in NSCLC patients.
  • The test is designed to identify approximately 3 to 5 percent of NSCLC patients who would be candidates for XALKORI therapy.
  • The diagnostic test will be available to clinicians and pathologists through Abbott Molecular, expanding the use of FISH technology in cancer diagnostics.
  • The simultaneous FDA approvals are expected to change clinical practice for the diagnosis and treatment of patients with NSCLC.
  • Lung malignancies are the leading cause of cancer deaths worldwide, with over 1.6 million new cases diagnosed each year, and Abbott's test aims to help improve outcomes for these patients.
  • The Abbott ALK test has been designed as a companion diagnostic to Pfizer's XALKORI therapy, which is an oral first-in-class ALK inhibitor.

Statistics:

  • Approximately 3 to 5 percent of NSCLC patients would be candidates for XALKORI therapy.
  • Over 1.6 million new cases of lung malignancies are diagnosed each year.
  • About 85 percent of lung cancer patients have the non-small-cell type and are usually diagnosed with advanced disease, having a very low survival rate.
  • Abbott Molecular offers several tests using FISH technology, including the first FDA-approved FISH-based companion diagnostic, the PathVysion test.

Sources:

  • Abbott
  • US Food and Drug Administration (FDA)
  • Abbott Molecular
  • Contify.com (distributor of Abbott news releases)
  • National Cancer Institute (NCI)
  • World Health Organization (WHO)