ADAPTIVE BIOTECHNOLOGIES DIAGNOSTIC PORTAL: ACCOUNT LOGIN

Transcription

1 ACCOUNT LOGIN 1. Create an account. To set up your account for our online order entry and reporting system, please go to: After signing up, please see your 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 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.

2 3. Select an ordering physician and verify relevant physician information. Our Test Requisition Form (TRF) is filled out entirely online within the Diagnostic Portal. Select an ordering physician from the drop-down menu. Once selected, confirm the address for the physician is correct. Input the study code, if applicable. PM-US-cSEQ-0092 Page 2 of 10

3 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 10

4 ORDERING 1. 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. 2. Provide relevant billing information. Select the correct billing instructions from the drop-down menu and then fill out the required information. Verify the insurance information prior to each test order. Note: Adaptive accepts Medicare patients; clonoseq is not currently covered by Medicare. PM-US-cSEQ-0092 Page 4 of 10

5 3. 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 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 PM-US-cSEQ-0092 Page 5 of 10

6 4. 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 or fax the TRF to Clinical Services. 5. 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 Clinical Services P: (888) F: (866) E: clinicalservices@adaptivebiotech.com Submitted by: asmith@universityhospital.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Smith, Alexandra NPI No: PATIENT INFORMATION Johnathan Doe Date of Birth: 03/29/1966 MRN: Sex: Male THE clonoseq ASSAY INFORMATION University Cancer Hospital 1 North Street Seattle WA Ordering Physician Signature Date Ordered P: (206) Your signature constitutes a 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. Diagnosis(es)/Clinical Indication ICD Codes C90.00 Multiple myeloma not having achieved remission 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 9-10 OF THIS DOCUMENT.) PM-US-cSEQ-0092 Page 6 of 10

7 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 7 of 10

8 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 Clinical Services P: (888) F: (866) E: clinicalservices@adaptivebiotech.com Submitted by: asmith@universityhospital.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Smith, Alexandra NPI No: PATIENT INFORMATION Johnathan Doe Date of Birth: 03/29/1966 MRN: Sex: Male University Cancer Hospital 1 North Street Seattle WA Ordering Physician Signature Date Ordered P: (206) Your signature constitutes a 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. Diagnosis(es)/Clinical Indication ICD Codes C90.00 Multiple myeloma not having achieved remission 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 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 clinicalservices@adaptivebiotech.com Secure fax: (866) 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 8 of 10

9 CLONALITY (ID) TEST SAMPLE OF COMPLETED TRF Page 1 of 2 Clinical Services P: (888) F: (866) E: clinicalservices@adaptivebiotech.com Submitted by: asmith@universityhospital.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Smith, Alexandra NPI No: PATIENT INFORMATION Johnathan Doe Date of Birth: 03/29/1966 MRN: Sex: Male THE clonoseq ASSAY INFORMATION B-cell Clonality SPECIMEN INFORMATION Blood 1 Fresh University Cancer Hospital 1 North Street Seattle WA Compartment Anticoagulant Anticoagulant Aspirate Slides 3 4 gdna Cell Pellet 1 Concentration Cell Count Cell Suspension 1 FFPE Scrolls 2 FFPE Slides 3 4 Plasma 6 P: (206) Your signature constitutes a 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. Cell Count Compartment Cell-free (cfdna) Ordering Physician Signature Date Ordered Diagnosis(es)/Clinical Indication ICD Codes C90.00 Multiple myeloma not having achieved remission Please complete a separate order form for each specimen sent. Consult specimen requirements for each test. Cellular (gdna) EDTA EDTA Tissue Lymph Node Lymph Node Cell-free (cfdna) 5 T Cells T Cells B Cells B Cells Adaptive accepts fresh peripheral blood. 2 Adaptive does not accept decalcified bone marrow core biopsies. 1 This type of specimen requires manual processing which may delay turnaround time. 2 Please send 5-10 five micron (5 μm) thick scrolls. 3 Please send 3-5 slides. 4 Slides with cover slips require manual processing which may delay turnaround time. 5 Blood samples intended for cell-free DNA testing must be received by Adaptive within 1-2 days of collection. 6 Plasma samples must be frozen immediately after isolation and shipped frozen to Adaptive within 1 week of collection. Collection Date Retrieval Date 06/01/2015 SHIPPING INSTRUCTIONS 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. Alexandra Smith Ship specimen and clonoseq Test Requisition Form overnight to Adaptive Biotechnologies (using FedEx account number ) 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 Requisition Form. 06/05/2016 SAMPLE Ship to: Adaptive Biotechnologies Attention: Clinical Lab 1551 Eastlake, Suite 200 Seattle, WA CONTINUED ON NEXT PAGE D Copyright 2016 Adaptive Biotechnologies Corp. All rights reserved. PM-US-cSEQ-0092 Page 9 of 10

10 TRACKING (MRD) TEST SAMPLE OF COMPLETED TRF Page 1 of 2 Test Requisition Form (TRF) Clinical Services P: (888) F: (866) E: clinicalservices@adaptivebiotech.com Submitted by: asmith@universityhospital.com Please complete all the required items: Ordering Physician Signature ORDERING PHYSICIAN INFORMATION Smith, Alexandra NPI No: PATIENT INFORMATION Johnathan Doe Date of Birth: 03/29/1966 MRN: Sex: Male THE clonoseq ASSAY INFORMATION Compartment Anticoagulant Anticoagulant Concentration Cell Count Cell Suspension 1 Cell Count University Cancer Hospital 1 North Street Seattle WA P: (206) Your signature constitutes a 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. Compartment Cell-free (cfdna) Ordering Physician Signature Date Ordered Diagnosis(es)/Clinical Indication ICD Codes C90.00 Multiple myeloma not having achieved remission Tracking test Include receptor(s) with dominant clonal sequence(s) as identified in the patient s Clonality Test(s) results. SPECIMEN INFORMATION Blood 1 Fresh Aspirate Slides 3 4 gdna Cell Pellet 1 FFPE Scrolls 2 FFPE Slides 3 4 Plasma 6 Please complete a separate order form for each specimen sent. Consult specimen requirements for each test. Cellular (gdna) EDTA EDTA Tissue Lymph Node Lymph Node Cell-free (cfdna) 5 T Cells T Cells B Cells B Cells Adaptive accepts fresh peripheral blood. 2 Adaptive does not accept decalcified bone marrow core biopsies. 1 This type of specimen requires manual processing which may delay turnaround time. 2 Please send 5-10 five micron (5 μm) thick scrolls. 3 Please send 3-5 slides. 4 Slides with cover slips require manual processing which may delay turnaround time. 5 Blood samples intended for cell-free DNA testing must be received by Adaptive within 1-2 days of collection. 6 Plasma samples must be frozen immediately after isolation and shipped frozen to Adaptive within 1 week of collection. Collection Date 04/01/2018 SHIPPING INSTRUCTIONS 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. Alexandra Smith Ship specimen and clonoseq Test Requisition Form overnight to Adaptive Biotechnologies (using FedEx account number ) 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 Requisition Form. 06/05/2016 SAMPLE Ship to: Adaptive Biotechnologies Attention: Clinical Lab 1551 Eastlake, Suite 200 Seattle, WA CONTINUED ON NEXT PAGE D Copyright 2016 Adaptive Biotechnologies Corp. All rights reserved. Clinical Services P: F: E: clinicalservices@adaptivebiotech.com Copyright 2018 Adaptive Biotechnologies Corp. All rights reserved. PM-US-cSEQ-0092 Page 10 of 10