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Crescendo Bioscience Studies at Upcoming ACR Meeting Explore Expanded Uses for Vectra DA

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NEW YORK (GenomeWeb) – Myriad Genetics subsidiary Crescendo Bioscience is looking to expand the utility of its Vectra DA rheumatoid arthritis (RA) panel as it works to drive physician adoption and payor coverage of the test.

At the American College of Rheumatology annual meeting held next week in Washington D.C., the company and its collaborators will present several studies exploring use of the test for predicting progression of the disease, helping to guide drug tapering in RA patients, and identifying patients at risk of myocardial infarction and serious infections due to RA, among other applications.

These and other studies are part of Crescendo's ongoing effort to increase use and coverage of the test, which has to date somewhat underperformed the commercial expectations Myriad announced for it upon acquiring Crescendo two years ago.

Vectra DA measures levels of 12 proteins to assess RA disease activity and is intended to supplement conventional tools like joint exams, c-reactive protein measures, and erythrocyte sedimentation rate tests.

Myriad purchased Crescendo in February of 2014 for $270 million, providing, at the time, a 2014 guidance of $65 million in revenues for the company. Since then, Vectra DA sales have hovered around $11 million to $13 million a quarter, most recently generating $12.7 million and $11.6 million in Q4 2015 and Q1 2016, respectively.

Private payor coverage for Vectra DA currently totals only around 2 million lives, but the test is covered by Medicare at a rate of $587 per test, and, speaking to GenomeWeb this week, Crescendo President Bernard Tobin noted that this market represents a roughly $600 million opportunity for the company.

To drive adoption within this market and secure additional private payor coverage, the company has undertaken a prospective clinical utility trial for which it has begun enrolling patients, Tobin said. Additionally, it is in discussions with several managed care plans to launch demonstration projects aimed at establishing the test's utility.

"There's a large part of the marketplace that hasn't recognized the value of [the test's] clinical utility yet," Tobin said, noting that Crescendo hopes to address this issue through such efforts.

Indeed, speaking last year to GenomeWeb, several rheumatologists noted their skepticism that the test provided enough benefit over conventional measures to justify its price tag, though others said they found the test useful for guiding therapy in their RA patients.

Crescendo's near term focus is on establishing the test's utility for assessing the aggressiveness of a patient's condition, which could allow doctors to, for instance, better determine when patients should be put on more aggressive treatment regimens, such as with biologics like AbbVie's Humera (adalimumab).

The studies to be presented at next week's ACR meeting are focused on this and other expanded utilities of the test. In the study perhaps most closely related to current uses of the test, researchers from the OPERA trial, including Crescendo employees, looked at 180 treatment-naïve early RA patients who were randomized to either treatment with methotrexate or methotrexate and adalimumab, to determine whether Vectra DA scores at baseline could predict radiographic progression of RA and whether the test's predictive value could add information to tests for anti-cyclic citrullinated peptide, the presence of which is associated with RA and increased RA activity.

The researchers found that baseline Vectra DA scores correlated with radiographic progression in the methotrexate-only group but not in patients treated with adalimumab, and that change in Vectra DA score from baseline to three months was not correlated with radiographic progression.

They also found that 31 percent of patients with high baseline Vectra DA scores progressed radiographically, while only 3 percent of patients with low baseline scores progressed, indicating that high scores are predictive of radiographic progression. Additionally, patients positive for anti-CCP but with low baseline Vectra DA scores did not progress, indicating that the test offers additional information beyond anti-CCP status.

Targeting a use that David Chernoff, Crescendo's senior vice president of medical affairs, said remains somewhat further off, is a study the company conducted with researchers at Japan's University of Occupational and Environmental Health that investigated whether Vectra DA could be useful in predicting relapse in patients tapering off adalimumab. 

Use of such tapering in patients who have achieved remission is growing, Chernoff said, but better tools for predicting the success of such tapers are needed.

"In order to be able to do this successfully you have to be able to scientifically guide the rate of discontinuation as well as [identify] who is going to be a good candidate versus somebody who remains a high-risk candidate you would not recommend taper," he said. "Because you obviously don't want to slow down someone's meds and then have the disease come roaring back. So that is something that is evolving and we are continuing to generate scientific data for peer review to support that application."

In the study, the researchers looked at 42 patients on methotrexate and adalimumab who had maintained remission based on joint exams and ESR tests for 24 weeks or more and had agreed to stop adalimumab treatment. At baseline the Vectra DA score characterized 22 of these patients as being in remission, six as having a low score, nine as having a moderate score, and five having high disease. At 52 weeks, 28.6 percent of patients had had flare-ups of RA, while 45.2 percent remained in remission. By Vectra DA score, 13.6 percent (showing remission at baseline), 50 percent (showing a low score), 33.3 percent (showing a moderate score), and 60 percent (showing a high score) had flares; while 63.6 percent (showing remission at baseline), 33.3 percent (showing a low score), 33.3 percent (showing a moderate score), and 0 percent (showing a high score) remained in remission.

"In a multivariate linear logistic regression model, [Vectra DA] scores were marginally associated with flare and [remission] after adjusting for disease duration," the study authors wrote.

In a third study, in which Crescendo was not involved, researchers from the University of Alabama looked at whether Vectra DA scores could be associated with myocardial infarctions and infections, two events associated with RA. Looking at 17,333 infection patients and 16,796 myocardial infarction patients, the researchers found that higher Vectra DA scores were associated with higher risk of being hospitalized for an infection and with myocardial infarction and cardiovascular events more broadly.

Such an application, Chernoff said, is "very aspirational" at this point, particular given the large study sizes that would be required to validate any such test.

"We think it is a future application, but it's not currently something we tell people to do as a way of monitoring these risks," he said. "But I think it shows the power of having a very sensitive and broad inflammatory panel that may, in the future, have interesting and important applications above and beyond what we originally developed the test for."

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