Clinicians

The 12 biomarkers in Vectra 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 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

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.

Vectra is a laboratory-developed test. Crescendo Bioscience, a Myriad company, has a Utah-licensed CLIA-certified laboratory dedicated to testing blood specimens for the Vectra test, with results reported within approximately 5-7 calendar days from shipping of the specimen to Myriad. Vectra is only available from Crescendo’s Clinical Laboratory.

Myriad 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.

Vectra specimen collection kits, which can be ordered through Customer Service 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. Up to 5 patient specimens can be shipped in each Vectra kit. Customer Service can be reached toll-free at 1-877-743-8639 or through our online order form.

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

Vectra 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.

Vectra can be a valuable complement to your clinical judgment in the assessment of RA disease activity. Vectra 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 at least 2 weeks prior to the visit.

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

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

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

References:
* 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

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

Medicare fully covers Vectra 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 Vectra CARE Financial Assistance program to meet the needs of each patient.

Myriad will bill for the test, as the provider of service, so your office will not be required to bill or collect for Vectra. Your patient may receive an Explanation of Benefits (EOB) from their insurance company. Myriad may be identified as the test provider on the EOB. Please note: the EOB is not a bill. If your patient owes anything, Myriad 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 1-877-743-8639.

Vectra categorizes RA disease activity and inflammation into:

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

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

High Vectra scores have been associated with a higher risk of radiographic progression – low/moderate scores have been identified with a lower risk of rapid radiographic progression. ^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 result, please contact Myriad at 1-877-743-8639.

References:
* 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.

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

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

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

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 score. Although the effect of the following situations on the Vectra score has not been evaluated, the literature indicates that proteins included in the Vectra 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.

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 test date, a change in Vectra 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 scores. Additionally it provides health care professionals with a user-friendly, seamless way to order Vectra tests and review Vectra test results.