Signatera (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.

Ordering Requirements:

• Providers must place an order for Signatera (Sendout) Panel (O366383) in Epic to ensure that order information and results transmit properly to Natera. This test code (RSIGNA) is the lab collection component associated with the panel.
• A Natera Signatera™ 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™ 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 EDTA (lavender top) tube from a Natera Signatera™ kit.

NOTE: If a clinic/inpatient provider performs a collection, they might collect only the two Streck tubes.* If so, do not cancel! Process as usual.

• If Signatera 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 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.

* The lavender top is required only for the first time a patient gets the Signatera test. Since the clinician knows whether the patient has had testing before, they might choose not to collect the lavender top. Lab staff, however, should always collect all three samples (two Streck plus one lavender-top), regardless of the patient's previous orders.

Store and transport whole blood samples at room temperature.

• HMC and UW-NW SPS: Forward samples and kit to UW-MT for sendout.
• Fred Hutch SPS: Send samples to Natera using provided kit. Close the order after sendout by entering NATSO for the pending RSIGTR (Signatera Sample Tracking) test.
• NOTE: If a clinic/inpatient provider performs a collection, they might collect only the two Streck tubes.* If so, do not cancel! Process as usual.

UW-MT Sendouts:

• If samples have not been sourced from a Natera kit, ensure that the expiration dates on 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 RSIGNA order by entering NATSO for the pending RSIGTR (Signatera Sample Tracking) component.
• Results will file directly from Natera to Epic via interface.

* The lavender top is required only for the first time a patient gets the Signatera test. Since the clinician knows whether the patient has had testing before, they might choose not to collect the lavender top. Lab staff, however, should always collect all three samples (two Streck plus one lavender-top), regardless of the patient's previous orders.

Signatera Clinical Support:

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