Therascreen® KRAS RGQ PCR Kit

Inclusion Criteria:

1. Patients with pathologically documented metastatic colorectal cancer (CRC).
2. Patients identified for inclusion in the Amgen Clinical Study (Protocol No. 20190172) who have signed and dated a valid informed consent form.
3. Patients must provide an archival tumor sample or a fresh tumor biopsy at baseline if an appropriate archival sample is unavailable.
4. Local KRAS data must be available for patient selection.
5. An archival tumor sample or fresh tumor biopsy is required for central confirmation of KRAS G12C status prior to enrollment.
6. Patient samples must meet the following criteria:

   1. A formalin-fixed paraffin-embedded (FFPE) tissue block (preferred) along with a de-identified pathology report.
   2. If an FFPE tissue block is unavailable, a minimum of 9-20 unstained slides (4-5 μm) must be submitted during screening for prospective central confirmation.
   3. If remaining tumor tissue from the KRAS status biopsy is unavailable, an alternative archival tumor sample may be submitted.
   4. If an alternative archival sample is unavailable or of insufficient quality, a new biopsy must be provided for central KRAS G12C confirmation.

   Submitted slides must be prepared using positively charged glass slides and cut within the past five years.
7. Patient samples must have been collected using one of the following methods:

   1. Core needle biopsy (CNB)
   2. Surgical resection (RES)
   3. Lavage samples

Exclusion Criteria:

1. Patients who do not meet all eligibility criteria for the Amgen Clinical Study (Protocol No. 20190172).
2. Patients with samples collected using one of the following methods:

   1. Fine needle aspiration (FNA)
   2. Brushings
   3. Cell pellets from pleural effusion
   4. Bone biopsy