Therapy Areas: Respiratory
US FDA Approves FoundationOneCDx as a Companion Diagnostic for Rozlytrek 
9 June 2022 - - US-based Foundation Medicine, Inc., a specialist in molecular profiling for cancer, has received approval from the US Food and Drug Administration for FoundationOneCDx to be used as a companion diagnostic for the two indications of Rozlytrek (entrectinib), a targeted therapy developed by Genentech, a member of Switzerland's Roche Group (SIX: RO) (OTCQX: RHHBY), the company said.

As a companion diagnostic, FoundationOne CDx can be used to identify patients with ROS1-positive non-small cell lung cancer (NSCLC), or patients with Neurotrophic Tyrosine Receptor Kinase fusion-positive solid tumors who may be appropriate for treatment with Rozlytrek (entrectinib).

As a condition of this approval, Foundation Medicine will conduct a post-approval study powered by the Flatiron Health-Foundation Medicine Clinico-Genomic Database to further demonstrate FoundationOne CDx's ability to identify NSCLC patients with ROS1 fusions who may respond to Rozlytrek (entrectinib).

The CGDB is a de-identified, HIPAA-compliant database that links outcomes data from Flatiron's network of oncology clinics and genomic data from Foundation Medicine's CGP assays. The database currently contains more than 100,000 linked genomic profiles.

NSCLC is the most common type of lung cancer, accounting for 80 to 85% of all lung cancer diagnoses.

When ROS1 gene fusions occur, generally in 1-2% of NSCLC diagnoses, 2 cancer cells grow and proliferate in an uncontrolled manner. 

NTRK gene fusions occur when NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins, which can activate signaling pathways involved in proliferation of certain types of cancer.

Though rare, occurring in roughly.3% of all solid tumors, these fusions can be found in many tumor types, including breast, cholangiocarcinoma, colorectal, gynecological, neuroendocrine, non-small cell lung, salivary gland, pancreatic, sarcoma and thyroid cancers.

CGP is an important tool for identifying these rare mutations.

Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient's tumor.

The test is FDA-approved as a companion diagnostic for 25 CDx indications, and 3 group claims across 30 targeted therapies, demonstrating Foundation Medicine's deep regulatory expertise. FoundationOne CDx is also the first and only companion diagnostic approved for Rozlytrek (entrectinib).

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability and tumor mutational burden using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens.

FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling.

Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms.


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