Frequently asked questions
- Can I use Vectra DA to confirm a diagnosis of RA?
- Which of my RA patients may benefit from Vectra DA?
- How often should I order Vectra DA for each of my patients?
- How is Vectra DA different than CRP testing?
- How should I interpret Vectra DA test scores?
- How reliable are the results of Vectra DA?
- Can the Vectra DA score be affected by the flu, vaccination, or other situations that affect the immune system?
- How was Vectra DA developed and validated?
- Will health insurance cover Vectra DA?
- Does Medicare cover Vectra DA?
- Will Medicare Advantage plans cover Vectra DA?
- Does Crescendo Bioscience provide financial assistance?
- How do I order a Vectra DA test?
- How do I receive the results of a Vectra DA test?
- What are the benefits of using the VectraView online portal?
- Should I order Vectra DA before or after a scheduled appointment?
- What laboratories are contracted to perform Vectra DA tests?
- Can results of the test be sent directly to my patients?
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.
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.
How often should I order Vectra DA for each of my patients?
Vectra DA can be considered anytime you assess disease activity. The frequency of the assessment, therefore, may vary for each patient and each physician.
How is Vectra DA different than CRP testing?
Vectra DA simultaneously measures 12 key proteins (including CRP) that are consistently associated with RA disease activity. In contrast, CRP is a single biomarker. Multivariate regression indicates that Vectra DA is an independent predictor of DAS28CRP, even after adjusting for CRP (P<0.001).
How should I interpret Vectra DA test scores?
Vectra DA scores >44 correspond to high disease activity, scores >29 but ≤44 correspond to moderate disease activity, and scores 1 to ≤29 correspond to low disease activity. The disease activity thresholds shown reflect the Vectra DA score equivalent to DAS28CRP cut-offs of 2.67 (low to moderate) and 4.09 (moderate to high), respectively (Inoue et al. Ann Rheum Dis. 2007;66:407-409), and were calculated by converting the DAS28 scale (0-9.4) to the Vectra DA scale (1 to 100).67
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) or firstname.lastname@example.org.
How reliable are the results of Vectra DA?
Vectra DA was validated in adults diagnosed with RA. The Vectra DA score was significantly associated with disease activity categories based on DAS28CRP† (P<0.001) in both a study of adults positive for RF and/or anti-CCP* and a separate study of adults who tested negative for RF and anti-CCP antibodies.*60 In 230 adults with RF+ and/or anti-CCP+ RA,* the area under the receiver operating characteristic (AUROC) curve was 0.77† and Pearson correlation was 0.56.60 In 141 adults who tested negative for both RF and anti-CCP antibodies,** the area under the receiver operating characteristic (AUROC) curve was 0.70.† and Pearson correlation was 0.43.60
† Based on a DAS28CRP cutoff of 2.67 as previously determined by Inoue, et al.61
* Patients were selected with the objective of achieving a uniform distribution of disease activity.
** Patients were selected with the objective of a disease activity distribution representative of the cohorts from which they were selected.
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.
How was Vectra DA developed and validated?
Vectra DA was developed using a broad survey of RA biology, with serial studies to determine a final assay composed of biomarkers that robustly assess disease activity. Approximately 400 candidate biomarkers were chosen from an extensive screen of literature, databases, and experimental data that included gene expression, protein arrays, and biological pathways. Of those, 130 candidates were screened in clinical studies. Successive studies in >1,300 total patients with RA refined the biomarker set to those 12 with the greatest ability to evaluate RA disease activity, based on association with clinical measures including the DAS28CRP. A statistical algorithm was developed that used the biomarker levels to calculate a disease activity score. Evaluation of the algorithm in an independent patient cohort validated its ability to quantify RA disease activity.
Will health insurance cover Vectra DA?
For patients who are covered under employer-sponsored health plans, until each insurance company provides a positive coverage statement, we will not know for sure if it will be covered by that insurance company. 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.
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).
Does Medicare cover Vectra DA?
For patients who have traditional Medicare (that is, patients who are not enrolled in a Medicare Advantage plan), Vectra DA is covered. Patients with traditional Medicare do not have copays or deductibles for lab tests.
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.
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 receiving Vectra DA, 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.
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 email@example.com.
How do I receive the results of a Vectra DA test?
Vectra DA 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 Crescendo Bioscience. However, results may 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.
What are the benefits of using the VectraView online portal?
VectraView is a secure, user-friendly online portal for both physicians and office staff. It provides health care professionals with a simple, seamless way to order Vectra DA tests, track the status of a test order, review Vectra DA test results, and follow patient medication use. The system also allows physicians to delegate access to the VectraView portal to their staff.
Should I order Vectra DA before or after a scheduled appointment?
Vectra DA can be a valuable complement to your clinical judgment in the tracking of RA disease activity, whether ordered before or after a scheduled appointment. Vectra DA may be most valuable when current test results are available at the time of each 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.
What laboratories are contracted to perform Vectra DA tests?
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.
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.