recommended blood draw and testing frequency
TRANSCRIPT
Follow up appointment with
oncologist (2-4 weeks post-op)
SampleCollectionSchedule
Treatment
Tissue
Blood
Initial Signatera testingComplete drawBegin
Signateratesting
Option 1
Follow recommendationsfor adjuvant treatmentresponse monitoring
Dignosis& biopsy Surgery Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8
Initiation ofadjuvant therapy
Recovery
Subsequent testing, draw withpre-treatment labs
Initial Signatera testing(pre-adjuvant treatment),
draw 2-4 weeks after surgery
Last draw for treatment response monitoring,followed by recurrence monitoring
2-4 weeks post-op
SampleCollectionSchedule
Treatment
Tissue
Blood
Dignosis& biopsy Surgery
Recommended blooddraw and testing frequency
Post-surgical monitoring for molecular residual disease (MRD)
Adjuvant—Treatment response monitoring
Adjuvant therapy Recurrence monitoring
Tissue
Blood
Initial Signatera testing
EDTA tube
Sample collection
Streck tubes
Tissue sample
Option 2
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Pre-treatmentLab 1
Pre-treatmentLab 2
Pre-treatmentLab 3
Pre-treatmentLab 4
Recommended blooddraw and testing frequency
Neoadjuvant—Treatment response monitoring
Recurrence monitoring after neoadjuvant therapy, surgery, or adjuvant therapy
Metastatic—Treatment response monitoring
Subsequent testing, draw withpre-treatment labs
Initial Signatera
testing
SampleCollectionSchedule
Treatment
Treatment
Tissue
Blood
Dignosis& biopsy
Initiation ofneoadjuvant therapy Surgery
Subsequent testing, draw withpre-treatment labs
Initial Signatera
testing
SampleCollectionSchedule
Tissue
Blood
Initialtimepoint
Every 3 months during �rst year after de�nitive treatment or remission
Every 6 months during second year of remission
Recurrence monitoring
Subsequent testing, draw withpre-treatment labs
Initial Signatera
testing
SampleCollectionSchedule
Tissue
Blood
Pre-treatmentlabs
Initiation ofmetastatic therapy Metastatic therapy
Completion ofde�nitive treatment
or remission
At the oncologist’s discretion:Draw at every cycle, or every three cycles
Blood sample collection instructions
1. Complete requisition form
• Select the appropriate Signatera screening option.
• Complete ALL appropriate �elds on the requisition form.
• Take one barcode sticker and af�x it to the requisition form. The remaining bar codes can be used for your paperwork.
• Fill two Streck tubes for all patients. An additional 6 mL EDTA is required for �rst time patients only.
• Fill all tubes completely. If insuf�cient volume is obtained, draw an additional tube.
• Allow 60–90 seconds for each tube to �ll.
• Use 21 gauge straight needle.
• Vein collapse may require second venipuncture with a fresh tube.
• Gently invert tube at least 8 times immediately after draw in order to thoroughly mix blood with reagents.
• Do NOT shake vigorously.
2. Collect blood sample
One 6mL EDTA tube AND two 10mL DNA Streck tubes
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Do NOT store kits in an area where the temperature range is outside 18–30ºC or 65–86ºF.
65°F18°C
86°F30°C Do NOT expose
blood to temperatures outside the range of 43–98ºF or 6–37ºC.
43°F6°C
98°F37°C
Blood sample collection instructions
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Blood sample collection instructions
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3. Pre-pack sample
A Complete information on tube labels.
B Place �lled and labeled tubes into the absorbant sleeve and into the metallic envelope. Place the metallic envelope into the biohazard bag.
This test was developed by Natera, Inc., a laboratory certi�ed under the Clinical Laboratory Improvement Amendments (CLIA). This test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the US, certi�cation of the laboratory is required under CLIA to ensure the quality and validity of the tests. ©2019 Natera, Inc. All Rights Reserved.
MLB-10088_Rev01_SGN_Blood sample instructions_2019_07_31_NAT-801953
201 Industrial Road, Suite 410 | San Carlos, CA 94070 | www.natera.com | 1.650.489.9050 | Fax 1.650.412.1962
4. Shipping
A Pack blood sample, completed requisition form, copy of patient's insurance, and the cool pack included, into the Signatera Blood Collection Kit box.
B Place the kit box into the FedEx Clinical Pak envelope provided and af�x the prepaid shipping label. Call 1.800.GO.FEDEX to arrange a pickup.
+
Blood samplepacking and shipping
Conceive. Deliver. Thrive.
ClinicalPak