This article has been corrected to note that Vectra DA doesn't diagnose rheumatoid arthritis but assesses patients' disease activity.
By Turna Ray
Crescendo Bioscience last week announced the commercial launch of Vectra DA, a multi-biomarker blood test that aims to help doctors manage rheumatoid arthritis patients.
By gauging 12 proteins, Vectra DA yields a score between 1 and 100 that quantifies RA disease activity. Then, after this initial assessment, doctors can continue to monitor patients to track how the disease progresses.
The test is available through Crescendo Bioscience's CLIA-certified laboratory to doctors in 47 states. Crescendo Bioscience's laboratory license is pending in Maryland and Rhode Island, and the company is planning to apply for lab certification in New York.
"The tools the rheumatologists currently use to assess patients' inflammatory disease activity or erosive activity or to select drugs, are very subjective, very limited," William Hagstrom, CEO of Crescendo Bioscience, told PGx Reporter last week. He estimated that with the availability of nine marketed drugs for RA, there is approximately $6 billion of drug spend in this disease category.
"There have been a number of studies that have shown that if you measure patients' disease activity and make rapid treatment decisions, you can get more patients into clinical remission," Hagstrom said. "We can get patients into clinical remission, but we don't cure an autoimmune patient. Yet, only 10 percent to 20 percent of US RA patients are in remission."
Vectra DA gauges the following protein markers: IL-6, EGF, VEGF-A, Leptin, SAA, CRP, VCAM-1, MMP-1, MMP-3, Resistin, YKL-40, and TNF-RI. The 100 point score yielded by the test, translates to low disease activity with a score of between 1 to 29; moderate disease activity with scores greater than 29 and less than 44; and high disease activity with a score more than 44.
At the ACR/ARHP Annual Scientific Meeting this week, Crescendo Bioscience presented several studies demonstrating the clinical and analytical validity of Vectra DA. In one study, Crescendo Bioscience compared quantification of RA disease activity by Vectra DA and disease assessments by DAS28CRP. Although a validated tool for gauging RA activity, DAS28CRP requires the doctor to squeeze patients' tender and swollen joints.
In this study by Curtis et al., researchers reported that the Vectra DA Test score was an independent predictor of assessments by DAS28CRP in multivariate analysis. "In longitudinal analysis, there was a significant association between change in [the Vectra] DA Test score and change in DAS28CRP (p
Crescendo Bioscience is planning to market the test to the 3,500 US rheumatologists using 10 sales representatives. The company plans to scale up its sales force in the coming months.
According to company officials, because Vectra DA allows doctors not only to assess the disease activity in patients with RA but also to track their disease progression, Crescendo Bioscience is expecting to see a revenue opportunity with each repeated visit of an RA patient to a rheumatologist.
"The usage for most molecular tests is once in a lifetime," Ted Snelgrove, Crescendo Bioscience's chief commercialization officer, pointed out. "Vectra DA is very different from other tests. If we're tracking disease activity with Vectra DA, it could be used several years in these patients over years and decades."
The test will most likely be priced at between $400 and $500. According to Hagstrom, the price of the test breaks down to about $40 per marker assessed. The company is currently discussing reimbursement options for the tests with insurers, but has not solidified a reimbursement contract yet.
After Vectra DA, Crescendo Bioscience is planning to launch three other tests for RA. In 2011, the company is planning to launch Vectra SD, a test that measures RA patients' dynamic erosive activity, and can help doctors manage patients with radiographic measurements.
In the next 36 months Crescendo Bioscience plans to introduce Vectra TS to predict best responders to RA drugs and a cardiovascular test that will help doctors gauge the between 30 percent to 50 percent of RA patients who are at risk of dying from heart complications. Vectra TS is being further studied in a RA PGx trial called BATTER-UP (see related article).
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