ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: ACCOUNT LOGIN 1. Create an account. To set up your account for our online order entry and reporting system, please go to: https://diagnostics.adaptivebiotech.com/account/login. After signing up, please see your email for a link to set up your password. After completing this step, if you have not filled out a Physician Registration Form contact Clinical Services. 2. After logging in, you will be prompted to create a new order. clinicalservices@adaptivebiotech.com Welcome Get started by creating a new order. NEW ORDER Multiple ways to create a new order For a full listing of terms and conditions governing use of this Portal, please visit https://diagnostics.adaptivebiotech.com/termsofuse. clonoseq is an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies for use in B-cell acute lymphoblastic leukemia and multiple myeloma patients to detect and monitor measurable residual disease (MRD) in bone marrow samples. clonoseq is also available for use in other lymphoid cancers as a CLIA-regulated laboratory developed test (LDT) service provided by Adaptive Biotechnologies. clonoseq is available by prescription only. For important information about the FDA-cleared uses of clonoseq, including test limitations, visit clonoseq.com/technical-summary.
3. Select an ordering physician and verify relevant physician information. Our Test Requisition Form (TRF) is filled out entirely online within the Diagnostic Portal. clinicalservices@adaptivebiotech.com Select an ordering physician from the drop-down menu. clinicalservices@adaptivebiotech.com Once selected, confirm the address for the physician is correct. Input the study code, if applicable. PM-US-cSEQ-0092 Page 2 of 13
ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: PATIENT SET-UP 1. Select a patient and diagnosis. Select Pick a Patient on the main screen. Search for an existing patient. OR Click to create a new patient and then input the required patient information. 2. Select the correct Diagnosis / ICD code by searching in the text box. PM-US-cSEQ-0092 Page 3 of 13
ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: ORDERING 1. Click on the Pick a Test button. Click here to access the clonoseq testing menu 2. Select the test you wish to order. You may order either a Clonality (ID) Test, which identifies the dominant sequence(s) in a diagnostic sample, or a Tracking (MRD) Test to monitor the presence and level of MRD. For a new (not previously tested) patient, the Clonality (ID) Test should be ordered first. If you select Tracking (MRD) Test for a patient who doesn't already have a Clonality (ID) Test result, you will be notified that a Clonality (ID) Test is required. Select which clonoseq Assay test you would like to order. For the Clonality Test, select B-cell Test, T-cell Test, or both. If ordering a Tracking Test, click the checkbox here. PM-US-cSEQ-0092 Page 4 of 13
3. Read and acknowledge the information provided about clonoseq s FDA-cleared uses. Review this information. Click the button here to acknowledge this information and move forward with your order. 4. Confirm that the correct test was selected in your order. If you need to go back and make changes to the test you selected, click the Edit Test button to return to the test selection menu. Confirm correct test is listed here. Click here if you need to make changes. PM-US-cSEQ-0092 Page 5 of 13
5. Provide relevant billing information. Select the correct billing instructions from the drop-down menu and then fill out the required information. Note: Adaptive accepts Medicare patients; clonoseq is not currently covered by Medicare. Verify the insurance information prior to each test order. 6. OPTION A Provide specimen information and shipping instructions. Select Shipping to Adaptive under the first drop-down menu. Select the type of sample that will be sent under the second drop-down menu. Once selected, please fill out the information that is requested. Option A: Ordering physician sends sample PM-US-cSEQ-0092 Page 6 of 13
6. OPTION B Provide specimen information and shipping instructions. Please submit the following to Clinical Services to request assistance with sample collection: 1) Signed clonoseq Test Requisition form (to be printed upon completion of this order) 2) Complete Pathology Report 3) Copy of the patient's insurance card Select Adaptive Assists with specimen retrieval under the first drop-down menu. Option B: Adaptive Biotechnologies assists with specimen retrieval 7. Submit your order To submit the order, click Submit on the top left side of your screen. After saving, you will be prompted to print and sign the Test Requisition Form. You can easily download a PDF of the TRF by clicking Download TRF in the bottom right corner. After printing, please ensure that the specimen type, collection date, and unique identifier are all filled in. Include the signed TRF with your shipment. If Adaptive Biotechnologies is assisting with specimen retrieval, please email or fax the TRF to Clinical Services. PM-US-cSEQ-0092 Page 7 of 13
8. Sign the clonoseq Test Requisition Form (TRF) after printing the completed order Required sections missing information on the printed TRF will be highlighted yellow. Missing information will result in test processing delays. The Ordering Physician must sign and date the TRF to confirm that the test ordered is medically necessary based on his/her independent medical judgment and that the information submitted is accurate to the best of his/her knowledge. Page 1 of 2 Test Requisition Form (TRF) Clinical Services P: (888) 552-8988 F: (866) 623 4408 E: clinicalservices@adaptivebiotech.com Submitted by: iancona@adaptivebiotech.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Gregstorm, Lionel NPI No: PATIENT INFORMATION Doe John Date of Birth: 03/19/1937 MRN: ACH-298732 Sex: Male THE clonoseq ASSAY INFORMATION Isabel Test Factory 123 Miami St Roni WA 91289 Ordering Physician Signature Date Ordered P: (707) 276-0012 Your signature constitutes a Statement of Medical Necessity and your certification of, and agreement to, the following: (1) you are either an ordering physician, or a non-physician practitioner operating within the scope of your authority under state law; (2) the clonoseq assay is medically necessary for this patient, and the test results will be used with other clinical data to determine an appropriate treatment plan for this patient; (3) you or your institution have obtained the patient's consent for Adaptive to release test results and other personal health information to the patient's third-party payer in connection with the reimbursement process. 123 Main Street Boston, MA 02130 P: 206-365-3093 Diagnosis(es)/Clinical Indication ICD Codes C90.02 Multiple myeloma in relapse Read the form and the certification below the signature line carefully before signing. To complete, sign and date the form. NOTE: Required sections missing information on the printed TRF will be highlighted yellow. MISSING INFORMATION WILL RESULT IN TEST PROCESSING DELAYS. (Sample TRFs can be found on pages 12-13 of this document.) 9. If desired, confirm the test regulation level that was applied to your order. Information on the regulation level (FDA-cleared IVD or CLIA-regulated LDT) will be available on the Orders List (the default homepage when you log in to the portal) after your sample has been received and reconciled. Check here for information on test regulation level. PM-US-cSEQ-0092 Page 8 of 13
If you would like more information about the FDA-cleared uses of the clonoseq Assay and/or the uses offered as part of our CLIA-regulated lab-developed test (LDT) service, click on the information (i) icon in the column header. Click here for regulation level definitions. PM-US-cSEQ-0092 Page 9 of 13
ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: PATHOLOGY SPECIMEN ASSISTANCE Request assistance with retrieving a stored pathology specimen. If you are requesting assistance from Adaptive to retrieve a stored specimen for a Clonality (ID) Test, you must locate a high-disease-load specimen from diagnostic work-up and the matching pathology report for the specimen. 1. Navigate to the Specimen Information section of the online Test Requisition Form (TRF) Select Adaptive assists with specimen retrieval under the first drop-down menu in the Specimen Information section when ordering. 2. In the Special Instructions box that appears, enter: a. Location of stored pathology specimen from diagnostic work-up (must be a high-disease load specimen). Include address and phone number for outside labs. b. Accession Number of the specimen (must match the number on the pathology report). c. Collection Date including the year d. Specimen Type (e.g. bone marrow aspirate, slides or scrolls recut from a FFPE tissue block) we cannot accept decalcified material or FFPE blocks at this time. For a complete list of acceptable specimen types, view our Test Specimen Requirements, located on the Diagnostic Portal. PM-US-cSEQ-0092 Page 10 of 13
3. Sign the clonoseq Test Requisition Form (TRF) after printing the completed order Required sections missing information on the printed TRF will be highlighted yellow. Missing information will result in test processing delays. The Ordering Physician must sign and date the TRF to confirm that the test ordered is medically necessary based on his/her independent medical judgment and that the information submitted is accurate to the best of his/her knowledge. Page 1 of 2 Test Requisition Form (TRF) Clinical Services P: (888) 552-8988 F: (866) 623 4408 E: clinicalservices@adaptivebiotech.com Submitted by: iancona@adaptivebiotech.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Gregstorm, Lionel NPI No: PATIENT INFORMATION Doe John Date of Birth: 03/19/1937 MRN: ACH-298732 Sex: Male Isabel Test Factory 123 Miami St Roni WA 91289 Ordering Physician Signature Date Ordered P: (707) 276-0012 Your signature constitutes a Statement of Medical Necessity and your certification of, and agreement to, the following: (1) you are either an ordering physician, or a non-physician practitioner operating within the scope of your authority under state law; (2) the clonoseq assay is medically necessary for this patient, and the test results will be used with other clinical data to determine an appropriate treatment plan for this patient; (3) you or your institution have obtained the patient's consent for Adaptive to release test results and other personal health information to the patient's third-party payer in connection with the reimbursement process. 123 Main Street Boston, MA 02130 P: 206-365-3093 Diagnosis(es)/Clinical Indication ICD Codes C90.02 Multiple myeloma in relapse Read the form and the certification below the signature line carefully before signing. To complete, sign and date the form. 4. Send the following via secure email or fax a. Copy of the complete Pathology Report, with matching accession number of the desired specimen. b. Signed TRF c. Copy of the patient's insurance card Secure email: clinicalservices@adaptivebiotech.com Secure fax: (866) 623-4408 Do not include cytogenetic reports, flow cytometry reports, patient charts, etc. A missing pathology report will result in significant order processing delays. PM-US-cSEQ-0092 Page 11 of 13
ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: CLONALITY (ID) TEST SAMPLE OF COMPLETED TRF Page 1 of 2 Test Requisition Form (TRF) Clinical Services P: (888) 552-8988 F: (866) 623 4408 E: clinicalservices@adaptivebiotech.com Submitted by: iancona@adaptivebiotech.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Gregstorm, Lionel NPI No: Isabel Test Factory 123 Miami St Roni WA 91289 Ordering Physician Signature Date Ordered Alexandra Smith 06/05/2016 P: (707) 276-0012 Your signature constitutes a Statement of Medical Necessity and your certification of, and agreement to, the following: (1) you are either an ordering physician, or a non-physician practitioner operating within the scope of your authority under state law; (2) the clonoseq assay is medically necessary for this patient, and the test results will be used with other clinical data to determine an appropriate treatment plan for this patient; (3) you or your institution have obtained the patient's consent for Adaptive to release test results and other personal health information to the patient's third-party payer in connection with the reimbursement process. PATIENT INFORMATION Doe John Date of Birth: 03/19/1937 MRN: ACH-298732 Sex: Male THE clonoseq ASSAY INFORMATION B-cell Clonality SPECIMEN INFORMATION Blood 1 Fresh Bone Marrow Bone Marrow Aspirate Slides 1 2 gdna 3 Cell Pellet 4 Anticoagulant/Tube Anticoagulant/Tube Concentration Cell Count Cell Suspension 4 PBMC FFPE Scrolls 5 FFPE Slides 1 2 Plasma 6 Cell Count 123 Main Street Boston, MA 02130 P: 206-365-3093 Compartment Cell-free (cfdna) Diagnosis(es)/Clinical Indication ICD Codes C90.02 Multiple myeloma in relapse Please complete a separate order form for each specimen sent. Consult specimen requirements for each test. EDTA EDTA Skin PBMC Skin Skin Tissue Bone Marrow Bone Marrow Lymph Node Lymph Node Bone Marrow T Cells T Cells PBMC B Cells B Cells Bone Marrow 2 Bone Marrow 2 1 Adaptive accepts fresh peripheral blood. 2 Adaptive does not accept decalcified bone marrow core biopsies. 1 Please send 3-5 slides. 2 Slides with cover slips require manual processing which may delay turnaround time. 3 gdna extracted by an outside lab may be suboptimal for assessment in this assay. 4 This type of specimen requires manual processing which may delay turnaround time. 5 Please send 5-10 five micron (5 μm) thick scrolls. Place all scrolls from a single block into one 2.0 ml tube. 6 Plasma samples must be frozen immediately after isolation and shipped frozen to Adaptive within 1 week of collection. Collection Date 12/04/2018 SHIPPING INSTRUCTIONS SAMPLE Unique Specimen ID Used as part of the specimen name and referenced in the test report. Required if you are including multiple orders in a single shipment. Ship specimen and clonoseq Test Requisition Form overnight to Adaptive Biotechnologies (using FedEx account number 694314104) arriving by 10am PT Fresh and FFPE specimens should be shipped at ambient temperature Other stored specimens (e.g. gdna, cells) should be shipped on dry ice Specimens MUST be labeled with two unique patient identifiers matching patient information on the Test Requistion Form. Ship to: Adaptive Biotechnologies Attention: Clinical Lab 1551 Eastlake, Suite 200 Seattle, WA 98102 CONTINUED ON NEXT PAGE D-008035 Copyright 2016 Adaptive Biotechnologies Corp. All rights reserved. PM-US-cSEQ-0092 Page 12 of 13
ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: TRACKING (MRD) TEST SAMPLE OF COMPLETED TRF Page 1 of 2 Test Requisition Form (TRF) Clinical Services P: (888) 552-8988 F: (866) 623 4408 E: clinicalservices@adaptivebiotech.com Submitted by: iancona@adaptivebiotech.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Gregstorm, Lionel NPI No: Isabel Test Factory 123 Miami St Roni WA 91289 Ordering Physician Signature Date Ordered Alexandra Smith 06/05/2016 P: (707) 276-0012 Your signature constitutes a Statement of Medical Necessity and your certification of, and agreement to, the following: (1) you are either an ordering physician, or a non-physician practitioner operating within the scope of your authority under state law; (2) the clonoseq assay is medically necessary for this patient, and the test results will be used with other clinical data to determine an appropriate treatment plan for this patient; (3) you or your institution have obtained the patient's consent for Adaptive to release test results and other personal health information to the patient's third-party payer in connection with the reimbursement process. PATIENT INFORMATION Doe John Date of Birth: 03/19/1937 MRN: ACH-298732 Sex: Male THE clonoseq ASSAY INFORMATION Anticoagulant/Tube Anticoagulant/Tube Concentration Cell Count Cell Suspension 4 PBMC Cell Count 123 Main Street Boston, MA 02130 P: 206-365-3093 Compartment Cell-free (cfdna) Diagnosis(es)/Clinical Indication ICD Codes C90.02 Multiple myeloma in relapse Tracking test Include receptor(s) with dominant clonal sequence(s) as identified in the patient s Clonality Test(s) results. This Tracking Test order will be delayed until the pending/in-progress Clonality Test for this patient is completed and at least one dominant clone is identified. Please note that Adaptive will run and bill for two Tracking Tests (B-cell and T-cell) if indicated based on Clonality Test results. SPECIMEN INFORMATION Blood 1 Fresh Bone Marrow Bone Marrow Aspirate Slides 1 2 gdna 3 Cell Pellet 4 FFPE Scrolls 5 FFPE Slides 1 2 Plasma 6 Please complete a separate order form for each specimen sent. Consult specimen requirements for each test. EDTA EDTA Skin PBMC Skin Skin Tissue Bone Marrow Bone Marrow Lymph Node Lymph Node Bone Marrow T Cells T Cells PBMC B Cells B Cells Bone Marrow 2 Bone Marrow 2 1 Adaptive accepts fresh peripheral blood. 2 Adaptive does not accept decalcified bone marrow core biopsies. 1 Please send 3-5 slides. 2 Slides with cover slips require manual processing which may delay turnaround time. 3 gdna extracted by an outside lab may be suboptimal for assessment in this assay. 4 This type of specimen requires manual processing which may delay turnaround time. 5 Please send 5-10 five micron (5 μm) thick scrolls. Place all scrolls from a single block into one 2.0 ml tube. 6 Plasma samples must be frozen immediately after isolation and shipped frozen to Adaptive within 1 week of collection. Collection Date 12/05/2018 SHIPPING INSTRUCTIONS SAMPLE Unique Specimen ID Used as part of the specimen name and referenced in the test report. Required if you are including multiple orders in a single shipment. Ship specimen and clonoseq Test Requisition Form overnight to Adaptive Biotechnologies (using FedEx account number 694314104) arriving by 10am PT Fresh and FFPE specimens should be shipped at ambient temperature Other stored specimens (e.g. gdna, cells) should be shipped on dry ice Specimens MUST be labeled with two unique patient identifiers matching patient information on the Test Requistion Form. Ship to: Adaptive Biotechnologies Attention: Clinical Lab 1551 Eastlake, Suite 200 Seattle, WA 98102 CONTINUED ON NEXT PAGE D-008036 Copyright 2016 Adaptive Biotechnologies Corp. All rights reserved. Clinical Services P: 888 552 8988 F: 866 623 4408 E: clinicalservices@adaptivebiotech.com Copyright 2018 Adaptive Biotechnologies Corp. All rights reserved. PM-US-cSEQ-0092 Page 13 of 13