FAQs

Frequently Asked Questions

 

How was Vectra DA developed and validated?

The 12 biomarkers in Vectra DA were selected from a pool of 396 candidate biomarkers. The multistep development process involved over 1,900 serum samples from more than 1,700 patients. Vectra DA was validated against the DAS28-CRP in seropositive (AUROC = 0.77; P<0.001) and seronegative patients (AUROC = 0.70; P<0.001).1,2

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Where is the Vectra DA test performed?

Vectra DA is a laboratory-developed test. Crescendo has a California-licensed CLIA-certified laboratory dedicated to testing blood specimens for the Vectra DA test, with results reported within approximately 5-7 calendar days from shipping of the specimen to Crescendo Bioscience. However, results may be available as soon as 72 hours from shipping date. Vectra DA is only available from Crescendo’s Clinical Laboratory.

Crescendo is also a College of American Pathologists (CAP) – Accredited Laboratory and has a New York State Clinical Laboratory Evaluation Program (CLEP) laboratory permit to provide services to physicians/patients in New York.

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How do I order a Vectra DA test?

Vectra DA specimen collection kits, which can be ordered through Customer Service or your local Crescendo Representative, include everything needed to order a test, collect a blood specimen, and send the specimen to our CLIA laboratory for processing. Included in the kit is information on sample collection and shipping. Specimens for up to 5 patients can be shipped in each Vectra DA kit. Customer Service can be reached toll-free at 1-877-RHEUMDX (1-877-743-8639) or customerservice@crescendobio.com.

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How often should I order Vectra DA for each of my patients?

Vectra DA can be considered when you assess disease activity for a patient with RA. The frequency of the assessment, therefore, may vary for each patient and each physician.

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When should I order Vectra DA in relation to a scheduled appointment?

Vectra DA can be a valuable complement to your clinical judgment in the assessment of RA disease activity. Vectra DA is most valuable when current test results are available at the time of the patient visit. If you would like to have the results available at the time of the scheduled office visit, patients should have blood drawn for Vectra DA at least 2 weeks prior to the visit.

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Which of my RA patients may benefit from Vectra DA?

Vectra DA can be used in any adult patient with RA. Test results are intended to aid in the assessment of disease activity in RA patients when used in conjunction with standard clinical assessment. This test is not intended or validated to diagnose RA.

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Can I use Vectra DA to confirm a diagnosis of RA?

Vectra DA is not intended or validated for the diagnosis or confirmation of RA.

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How is Vectra DA different than CRP testing?

CRP is a single biomarker that is a non-specific measure of inflammation, whereas, Vectra DA measures 12 key proteins (including CRP) that are associated with RA disease activity. Multivariate regression analysis indicates that Vectra DA is an independent predictor of DAS28CRP, even after adjusting for CRP (P<0.001). Vectra DA has been shown to identify patients with clinically-relevant RA disease activity that can be missed by CRP. High Vectra DA scores have been associated with an increased risk of radiographic progression even when CRP is low.3

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Does Medicare cover Vectra DA?

Medicare fully covers Vectra DA with no copayment or deductible. (Medicare Advantage plans may require a copay.)

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Will Medicare Advantage plans cover Vectra DA?

Medicare Advantage plans do cover Vectra DA. However, patients enrolled in Medicare Advantage plans may have out-of-pocket costs such as copays and deductibles. Please call us at 1-877-RHEUMDX (1-877-743-8639), option 1, from 7 am to 4 pm PST for more information.

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Will health insurance cover Vectra DA?

Medicare fully covers Vectra DA with no copayment or deductible. (Medicare Advantage plans may require a copay.) For patients who are covered under employer-sponsored health plans, until the insurance company provides a positive coverage statement, we will not know for sure if it will be covered by that insurance company. However, insurance companies may still pay for the test without a formal coverage policy. If one of your patients should face a challenge with reimbursement, we offer comprehensive reimbursement services through the Crescendo Access & Reimbursement Essentials (CARE) program to meet the needs of each patient.

Crescendo will bill for the test, as the provider of service, so your office will not be required to bill or collect for Vectra DA. Your patient may receive an Explanation of Benefits (EOB) from their insurance company. Crescendo Bioscience may be identified as the test provider on the EOB. Please note: the EOB is not a bill. If your patient owes anything, Crescendo Bioscience will bill them directly.

Our experienced reimbursement specialists are available from 7 am to 4 pm PST, Monday through Friday, to answer any questions from you, your staff, or your patients. Simply call 1-877-RHEUMDX (1-877-743-8639).

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Does Crescendo Bioscience provide financial assistance?

Crescendo provides financial assistance programs for uninsured and underinsured patients through the Crescendo Access & Reimbursement Essentials (CARE) program. For patients who have no insurance or have insurance that does not cover the test, Vectra DA may be provided at no cost based on financial eligibility. For those who have insurance* and cannot afford the out-of-pocket costs, financial assistance may also be available.

*Not valid for services reimbursed under Medicare, Medicaid, or similar federal or state programs.

Before or after Vectra DA testing, patients can contact Crescendo to see if they qualify for financial assistance.

Crescendo will mail or fax the CARE financial assistance application form or it can be downloaded here.

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How do I receive the results of a Vectra DA test?

Vectra DA test reports are available via fax or mail, or through the VectraViewTM portal, based on your preference. Results are available within approximately 5-7 calendar days from shipping of the specimen to Crescendo Bioscience. However, results may sometimes be available as soon as 72 hours from shipping date. The report provides the Vectra DA score and score history, which can be used to enhance patient counseling.

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Can results of the test be sent directly to my patients?

Vectra DA test results will be returned to the ordering physician by fax, mail, or via Vectra View portal within approximately 5-7 calendar days from shipping of the specimen to Crescendo Bioscience. However, results may be available as soon as 72 hours from shipping date. Crescendo will send Vectra DA test results directly to patients upon their request. Crescendo encourages patients who request their test results directly to reach out to their rheumatologist to evaluate their Vectra DA score in the context of their condition and medical history.

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How should I interpret Vectra DA test scores?

Vectra DA categorizes RA disease activity into:

  • High = >44
  • Moderate = 30 to 44
  • Low = 1 to <30

 

The Vectra DA cutoffs were selected to correspond to cutoffs on the DAS28-CRP scale.4

High Vectra DA scores have been associated with a higher risk of radiographic progression – low/moderate scores have been identified with a lower risk. 3,5

These thresholds are provided as a guide and a complement to your clinical judgment to help inform patient management. If you have questions or would like assistance in interpreting a Vectra DA result, please contact Crescendo Bioscience at 1-877-RHEUMDX (1-877-743-8639).

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What is the effect of IL-6 therapy (tocilizumab) on Vectra DA?

Tocilizumab is designed to specifically target and inhibit IL-6 signaling. IL-6 is one of the 12 biomarkers included in Vectra DA. Change in the Vectra DA score during tocilizumab treatment may underestimate the change in clinical response due to increases in IL-6.

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Can the Vectra DA score be affected by the flu, vaccination, or other situations that affect the immune system?

As with other inflammatory measures such as ESR and CRP, physicians should be aware of the possibility that factors other than RA may affect the Vectra DA score. Although the effect of the following situations on the Vectra DA score has not been evaluated, the literature indicates that proteins included in the Vectra DA test could be affected by:

  • A current infection, especially if associated with systemic symptoms
  • A recent vaccination

For more information, contact Medical Affairs by contacting Customer Service at 1-877-743-8639.

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What are the benefits of using the VectraView online portal?

VectraView is a free, HIPAA-secured, online portal for both physicians and office staff.

VectraView provides practices with population management capabilities including a view of the aggregate results for all of a practice’s tested patients and the ability to generate patient lists based on disease activity, last Vectra DA test date, change in Vectra DA score or other attributes of interest. Ancillary tools include the ability for practices/providers to enter medications and clinical assessments and plot these in relation to each other and Vectra DA scores. Additionally it provides health care professionals with a user-friendly, seamless way to order Vectra DA tests and review Vectra DA test results.

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References:

* 1. Centola M, Cavet G, Shen Y, Ramanujan S, Knowlton N, Swan K, Turner M, Sutton C, Smith D, Haney D, Chernoff D, Hesterberg L, Carulli J, Taylor P, Shadick N, Weinblatt M, Curtis J. Development of a Multi-Biomarker Disease Activity Test for Rheumatoid Arthritis. PLOS ONE 2013 Apr 9;8(4):e60635. doi:10.1371/journal.pone.0060635. 

* 2. Curtis JR, et al. Validation of a novel multi-biomarker test to assess rheumatoid arthritis disease activity. Arthritis Care & Research. 2012; 64 (12):1794-1803. 

* 3. Hambardzumyan K, Bolce R, Saevarsdottir S, Cruickshank SE, Sasso EH, Chernoff D, Forslind K, Petersson I, Geborek P, van Vollenhoven RF. Pre-treatment multi-biomarker disease activity score and radiographic progression in early RA: results from the SWEFOT trial. Ann Rheum Dis 2014. doi:10.1136/annrheumdis-2013-204986 

* 4. Inoue E, et al. Comparison of Disease Activity Score (DAS)28-erythrocyte sedimentation rate and DAS28-C-reactive protein threshold values. Ann Rheum Dis. 2007;66:407-409. 

* 5. van der Helm-van Mil AHM, Knevel R, Cavet G, Huizinga TWJ, and Haney DJ. An Evaluation of Molecular and Clinical Remission in Rheumatoid Arthritis by Assessing Radiographic Progression. Rheumatology (Oxford). 2013. doi:10.1093/rheumatology/kes378.