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Adaptive’s knowledgeable team is ready to assist you

Order clonoSEQ® through Adaptive’s CLIA-Certified, CAP-Accredited, ISO 13485-certified laboratory in Seattle, Washington.

Contact Adaptive to learn more about ordering clonoSEQ testing services for your patients.

We will walk you through the process of:

  1. Creating an online portal account
  2. Confirming important details about your institution/practice
  3. Selecting preferences for how and to whom test results are delivered
  4. Completing an online clonoSEQ Test Requisition Form (TRF)
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The clonoSEQ testing service offers:

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ACTIONABLE RESULTS

Delivered within approximately 7 days (fresh specimens) or 14 days (stored specimens) from the date of sample receipt and reconciliation.*

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ONLINE ORDERING COMPLETION

Patient data is securely stored in our online portal, eliminating the need for repetitive manual data entry.

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AUTOMATED VERIFICATION

Ensures each order includes all the required information, reducing the likelihood of follow-up calls or processing delays.

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SHIPPING MATERIALS PROVIDED

Upon request, we can provide kits to help you collect and ship fresh, stored, and frozen specimens.

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SECURE REPORT ACCESS

View and search results for your patients via our Diagnostics Portal, or opt-in to receive secure fax reports.

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STORED SPECIMEN RETRIEVAL SUPPORT

Given permission, we can contact outside pathology labs to obtain access to stored diagnostic specimens for Clonality (ID) testing.

*Reconciliation ensures that all required information and documentation is correct for the patient, clinician, institution, order, and sample. In cases where a sample must be retrieved from a pathology lab and/or has been stored under certain conditions, reconciliation will add additional time to the testing process.

This page is intended for use by healthcare professionals of the United States.

clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers as a CLIA-validated laboratory developed test (LDT) service. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

DATA WITH DEPTH. RESULTS WITH RELEVANCE.®

The clonoSEQ testing process

When used to measure residual disease in lymphoid malignancies like multiple myeloma, B-cell acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL), the clonoSEQ Assay requires two testing steps to be completed sequentially:

FIRST: CLONALITY (ID) TEST THEN: TRACKING (MRD) TEST CONTINUE TRACKING
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    INITIAL TUMOR CLONALITY ASSESSMENT

    Identify the dominant malignant sequence(s) in a diagnostic sample via a Clonality (ID) Test. This step is required once for patients who are new to clonoSEQ testing.

    The clinician provides a high-disease load sample from the initial diagnostic work-up or clinical relapse. The clonoSEQ Assay identifies the dominant DNA sequence(s) that are typically associated with malignancy.[1]

    For details on accepted sample types, please refer to the clonoSEQ Specimen Requirements sheet.

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    ASSESS RESIDUAL DISEASE

    After completion of a Clonality (ID) Test, monitor the presence and level of the dominant clone(s) by ordering one or more Tracking (MRD) Tests.

    The clonoSEQ Assay then tracks the patient’s identified dominant DNA sequence(s) in follow-up samples taken during or after treatment. The assay also identifies any newly emerging sequences of interest each time the test is run.[1]

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    CONTINUE TRACKING MRD OVER TIME

    Serial use of the clonoSEQ Tracking (MRD) Test can help clinicians monitor disease burden over time including assessing response to treatment and detecting potential relapse before the manifestation of physical signs and symptoms.[1]

    clonoSEQ testing can be performed as many times as necessary to assess how disease burden has changed throughout the course of treatment and remission.

    For details on accepted sample types, please refer to the clonoSEQ Specimen Requirements sheet.

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CLONOSEQ TEST SPECIMEN REQUIREMENTS
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CLONOSEQ REPORTS OVERVIEW
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ORDERING CLONOSEQ: HELPFUL HINTS
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ABN INFORMATION SHEET
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ABN FORM
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BILLING PROCESS AND COVERAGE POLICY OVERVIEW
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Frequently Asked Questions

VIEW CLONOSEQ TESTING FAQ

All clinicians who wish to order must first complete a Physician Registration Form. This form can be obtained from and returned to Adaptive Clinical Services. Because this form will be updated on occasion, clinicians who have ordered in the past may be contacted by Adaptive to re-confirm their registration details.

In addition to the Registration Form, Adaptive will need to work with hospital-based institutions or practices treating hospital-registered patients to put in place a Laboratory Services Agreement which establishes the features of our service offering and agreed-upon billing terms. We will work with you and/or a colleague you designate to establish a mutually-beneficial agreement. Please contact Clinical Services or your Diagnostic Key Account Manager with questions about this process.

All Test Requisition Forms (TRFs) must be completed through our easy-to-use, secure online Diagnostic Portal. Please contact Clinical Services for information on how to set up an account.

Once you have completed a TRF within the Diagnostic Portal, please print, sign and date the TRF.

  • If you are shipping a specimen for testing, you must include the signed TRF inside the box containing the specimen.
  • If you are requesting pathology retrieval assistance from Adaptive, please send the TRF by secure email or fax to Clinical Services.

If you indicate on the TRF that your test order should be billed to the patient’s insurance, a front/back copy of the patient’s insurance card must be included with the TRF.

If you are shipping a specimen, please be sure to:

  • Follow the preparation and shipping instructions specified in the clonoSEQ Test Specimen Requirements, which are accessible in the documents section above.
  • Label the specimen tube with two unique patient identifiers to ensure proper identification.

Adaptive can provide a clonoSEQ Fresh Collection Kit and a clonoSEQ Frozen Shipper. To order, please contact Clinical Services. You may also use your own packaging materials; ship to the address listed at the top of this guide.

If desired, Adaptive can assist with the retrieval of archived pathology specimens. Requests for this assistance must be indicated in the Specimen Information section of the TRF. To enable pathology specimen retrieval, the patient’s complete pathology report must be included with the signed TRF.

Adaptive aims to provide accurate and timely patient results. You can expect to receive results in approximately 7 days for fresh specimens and 14 days for stored specimens, measured from the date that an appropriate sample is received and reconciled in Adaptive’s Seattle laboratory. Samples that arrive without requisite information will require additional time to reconcile.

Adaptive must have a valid Clonality (ID) Test result in order to generate a Tracking (MRD) Test result for a given patient. Delivery of clinical reports containing MRD results will be delayed until a corresponding Clonality (ID) result becomes available.

If you are requesting Adaptive assistance with pathology specimen retrieval, please note that lab response times to our requests vary considerably. The turnaround times listed above are measured from the date Adaptive receives and reconciles an appropriate specimen. Turnaround times do not include time required for specimen retrieval. If specimen retrieval is urgent, Adaptive recommends that the clinician request and submit the specimen directly from the pathology lab.

You can easily access patient results through Adaptive’s Diagnostic Portal—the same portal that you will use to complete clonoSEQ TRFs.

  • The Diagnostic Portal enables you to filter and sort patient reports so that you can find specific reports quickly and easily.
  • Upon release of new patient results, you will receive an email notification with a direct link to your patient’s report. You can also choose to have patient results delivered via secure fax.
  • You will only receive one email or fax notification per order, at the time when all results for the patient’s order are available. Results of individual tests within an order will always be available in real-time in the Diagnostic Portal.

This page is intended for use by healthcare professionals of the United States.

clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers as a CLIA-validated laboratory developed test (LDT) service. For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

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Citations

  1. clonoSEQ®. [technical summary]. Seattle, WA: Adaptive Biotechnologies; 2020. https://clonoseq.com/technical-summary.