Specimen collection should be scheduled in advance in order to obtain the specialty kit for collection from the Central supply area. Only collect specimens Mo – Th.
Draw patient using blood tubes supplied in the FoundationOne kit
Check the tubes provided in the FoundationOne Liquid CDx kits to confirm liquid is clear and without cloudiness or crystals.
Label the tubes with the supplied labels to indicate date of collection and two unique patient identifiers such as patient's full legal name and date of birth.
Collect two tubes of whole blood (8.5 mL per tube). Levels of ctDNA may decrease after chemotherapy, and we recommend that samples be collected shortly before chemotherapy or at least two weeks after the previous treatment.
Prevent backflow: tubes contain chemical additives and it is important to avoid backflow into patient
Collect specimens by venipuncture according to CLSI H3-A6.
Fill tubes completely (8.5mL per tube)
Remove teh tube from the adapter and immediately mix by gentle inversion 8 to 10 times. Inadequate or delayed mixing may result in inaccurate test results. One inversion is a complete turn of the wrist, 180°, and back.
Collection tubes from the FoundationOne CDx collection kit
The health care provider will fill out the test requisition form including patient insurance information. Testing should NOT be billed to our Allina Health facility.
For Medicare patients, the provider will also need to have the Medicare ABN Form filled out.
Ambient (strict) - 7 days
Refrigerated – NO
Frozen – NO
Not collected in kit tubes
Specimens refrigerated or frozen
FoundationOne Liquid CDx is a qualitative next generation sequencing based in vitro diagnostic test that uses targeted high throughput hybridization-based capture technology to detect and report substitutions,insertions and deletions (indels) in 311 genes, rearrangements in four (4) genes, and copy number alterations in three (3) genes. FoundationOne Liquid CDx utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from anti-coagulated peripheral whole blood of cancer patients collected in FoundationOne Liquid CDx cfDNA blood collection tubes included in the FoundationOne Liquid CDx Blood Sample Collection Kit. The test is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies.
Includes guideline-recommended genes and biomarkers to help guide therapy selection and identify clinical trial options for patients with solid tumors.