Signatera & Altera (Sendout)

Test Information: Signatera™ is a mPCR-NGS assay for detection and quantification of circulating tumor DNA (ctDNA) in the plasma of patients previously diagnosed with cancer. Individual-specific mutation signatures are identified by upfront tissue and matched normal whole exome sequencing. Altera™ offers a whole exome and transcriptome based approach for Comprehensive Genomic Profiling (CGP) with boosted >500X coverage for 440 medically important genes.

Ordering Requirements: A Natera Signatera and Altera™ kit is preferred for testing, but not required. If patients will be drawn at a site that does not stock kits, providers may select the "Lab Collect - Send Kit" option in the Signatera & Altera™ Epic order to arrange for a kit to be shipped directly to the patient prior to collection.

Collect 2 x 10 mL Streck Cell-Free DNA BCT® tubes (mottled black and tan) and 1 x 6 mL LAVENDER TOP (EDTA) tube from a Natera Signatera and Altera™ kit.

• If Signatera and Altera™ kits are not available at the collection site, lab staff may use Streck and Lavender top (EDTA) tubes on hand. DO NOT COVER UP THE EXPIRATION DATE ON THE TUBE.
• Fill all tubes completely and mix by gently inverting 8-10 times. Do not shake vigorously.
• Walk samples to the laboratory after collection. Do not transport via pneumatic tube system, as this may compromise the Streck collection tubes.
• When delivering samples to the lab, include the kit and the Natera requisition that prints from Epic.
• Clinics should not rely on DLMP to provide kits due to unknown volume of orders.

Store and transport whole blood samples at room temperature.

• HMC and UW-NW: Forward samples and kit to UW-MT for sendout.
• Fred Hutch: Send samples to Natera using provided kit. Close the order after sendout by entering NATSO for the pending RSIATR (Signatera and Altera Sample Tracking) test.

UW-MT Sendouts:

• If samples have not been sourced from a Natera kit, ensure that the expiration dates on all of the tubes are visible.
• Package samples along with the Natera requisition (printed from Epic) and ship at room temperature using the provided kit.
• Samples may be shipped on Friday for Saturday delivery.

Stability:

• Lavender Tubes: Ambient (required): 14 days; Refrigerated: Unacceptable; Frozen: Unacceptable.
• Streck Tubes: Ambient (required): 9 days; Refrigerated: Unacceptable; Frozen: Unacceptable.

CAST:

• Print a pending UNATSO worksheet.
• Use Sunquest 'Audit Trail' to confirm that the sample has been sent out.
• Close the RSIALT order by entering NATSO for the pending RSIATR (Signatera and Altera Sample Tracking) component.
• Results will file directly from Natera to Epic via interface.

Signatera & Altera Clinical Support:

• Phone: 650.489.9050
• Email: signateracc@natera.com