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:

• Providers must place an order for Signatera and Altera Panel (O374177) in Epic to ensure that order information and results transmit properly to Natera. This test code (RSIALT) is the collection component associated with the panel.
• 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