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Crescendo Aims for 'Full Launch Velocity' for Vectra DA, Focus on Educating RA Patients in 2013

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Originally published Jan. 8.

A portion of the $28 million that Crescendo Bioscience recently secured in financing will go toward educating rheumatoid arthritis patients about its flagship Vectra DA molecular diagnostic for assessing disease activity, according to company officials.

The privately held diagnostics firm last week announced the completion of a $28 million Series D financing round led by Skyline Ventures and Safeguard Scientifics. Existing investors Mohr Davidow Ventures, Kleiner Perkins Caufield & Byers, Aeris Capital, and others also contributed funds that will be used to bolster commercialization efforts around Crescendo's flagship Vectra DA molecular test. Specifically, Crescendo will use the financing to expand its sales force, increase greater adoption of the test among rheumatologists, conduct additional studies to further establish the clinical utility of the test, and raise patient awareness about the diagnostic.

Patient outreach will be a relatively new area of focus at Crescendo for the Vectra DA test, which the company launched in the US in 2010. Vectra DA is multi-biomarker blood test that gauges disease activity in rheumatoid arthritis patients. The test assesses the serum concentrations of 12 immune, endothelial, bone, cartilage, and metabolic biomarkers associated with rheumatoid arthritis and uses an algorithm to generate a disease activity score for a patient between one and 100.

According to Crescendo CEO William Hagstrom, the firm will begin working with patient advocacy groups to ramp up awareness of the Vectra DA test among rheumatoid arthritis patients. "We've been slowly walking into direct-to-patient programs. I said slowly because we wanted to establish our presence well with physicians before we built too much visibility on the patient side," Hagstrom told PGx Reporter. "But the time is now to do that."

Throughout 2012, Crescendo expanded its sales force, which enabled the company to reach 500 rheumatologists who have used Vectra DA. Starting with 10 sales representatives in mid 2011, Crescendo currently has a sales force of 20 reps. Hagstrom said that the company plans to add 10 more reps in 2013.

To date, Crescedo has reached about 15 percent of 3,500 rheumatologists in the US, and according to Hagstrom, this year the company hopes to reach roughly 25 percent of the physician specialty. Additionally, this year Crescendo aims to analyze around three times the number of unique patient samples assessed by Vectra DA in 2012, or approximately 90,000 samples.

On the patient education front, Crescendo is collaborating with organizations that are in close contact with rheumatoid arthritis patients and that have a web presence to spread the world about Vectra DA. One organization Crescendo is working with is Creaky Joints, the largest advocacy group for arthritis patients in the US. "We're working in a very collaborative sense with the leadership at Creaky Joints," Hagstrom said.

Rheumatoid arthritis is a chronic disease that affects 1.5 million people in the US. Current methods of tracking disease activity are subjective, including gauging the signs and symptoms of the disease, assessing structural damage in joints, and determining functionality, such as patient-reported measurements of pain. Crescendo is marketing Vectra DA as an objective measure of rheumatoid arthritis activity that can be used in concert with standard disease-assessment tools. "Having a quantitative, numbers-based approach [in disease tracking] is something that rheumatoid arthritis patients have been looking for for quite some time," Hagstrom said.

In an effort to provide tools that enable patients to more accurately track their disease, Crescendo also just launched an iPhone application called MyRA. The application allows patients to keep tabs on how their disease is progressing between office visits in terms of symptoms and functionality. With the agreement of their doctors, through this application patients can also access their Vectra DA results, drugs they are taking, and at which doses.

"Our market research showed that about 60 percent of patients were self tracking [their disease] less than ideally and presenting notes or calendars to their physicians," Hagstrom said. "The MyRA tool will allow patients to have a more productive office visit, because it can communicate what patients want communicated [to their physicians] while adding graphics and [tracking] how symptomology has been doing between visits."

Response to MyRA has been positive, according to Crescendo. Hagstrom noted that patients who have used the tool seem to like it and doctors that have seen it feel like they have a more informative encounter with patients.

Crescendo plans to invest more this year in studies that illustrate how Vectra DA impacts physicians' and patients' decision making. At a medical conference in Europe in 2012, the company presented data from a study evaluating how six healthcare professionals in community practices used the Vectra DA disease activity score to make decisions for 101 patient visits.

The test scores contributed to the physicians changing their treatment plan in 38 percent of cases and all six doctors said they planned to use the test for all their patient visits. The physicians when surveyed said that the Vectra DA test was "very valuable" in 84.2 percent of cases, "somewhat valuable" in 13.9 percent of cases, and "not valuable" in 2 percent of cases.

"In a separate project, we showed that not only do [doctors] change their decisions, but patients feel more engaged, they feel more satisfied with the decision, and docs and patients say the process is more streamlined," Hagstrom said.

The average age of diagnosis of rheumatoid arthritis is mid-to-late 40s, and the disease affects more women than men. Patients with rheumatoid arthritis generally want to be more involved in making healthcare decisions than the average consumer. Because they deal with the disease daily, rheumatoid arthritis patients seek out information on the latest treatment advances.

A rheumatoid arthritis patient "tends to be an individual who is extraordinarily interested in being educated, being in the workforce, being productive, being able to be as functional as possible," Hagstrom said. "This is a disease that patients live with every day for the rest of their lives; they tend to be very starved for information [about] how they're doing."

Hagsrom added that Crescendo's market research revealed "overwhelmingly strong" interest among patients in a molecular diagnostic such as Vectra DA. "We think we've hit a real nerve here, and we're looking forward to seeing how far that can take us in 2013," he added.

In 2013, Crescendo will try to reach "full launch velocity" in terms of Vectra DA sales. To spur greater adoption, the company will continue to conduct studies to demonstrate the science behind the Vectra DA technology.

At the American College of Rheumatology's annual meeting in November, the company presented data from several studies supporting the use of Vectra DA as a tool to track disease activity in patients treated with a variety of treatments, such as methotrexate and prednisone, the monoclonal antibody tocilizumab, and the JAK inhibitor tofacitinib. "We did a dozen plus studies in 2012," Hagstrom added. "We'll do that number or greater [this year]."

Crescendo will use the published and forthcoming studies on Vectra DA to convince payors to reimburse the test. Additionally, the company is in the process of applying for Medicare coverage for the diagnostic through the MolDx program. "The compelling story to any payor … is that this is a patient population that has active disease, and only 15 percent to 20 percent are in remission and studies have shown that 50 percent could be in remission," Hagstrom explained. "So, patients that have active disease are more expensive, they have co-morbidities, and are at high risk for disabilities."

Additionally, a test that can assess whether patients' disease is being managed by the treatment they're on can save the healthcare system money. "Rheumatoid arthritis drug costs consume 23 percent to 27 percent of most health plans' special drug cost budget," Hagstrom cited. "In some plans, rheumatoid arthritis is more expensive than [treating] cancer."

Crescendo will continue working with drug developers to conduct biomarker studies, perform analysis involving Vectra DA, or provide biology modeling for marketed drugs or investigational agents. Crescendo did approximately six such studies with pharma partners in 2012.

"We believe that work will expand in 2013 as people come to better understand how Vectra DA can better help them separate drug effect from placebo, or can tell early the response curve — how patients are likely to do at the standard 90-day interval," Hagstrom noted. "For those that have drugs in the development cycle, we've been told that we can better help them identify the right dose to take forward in their studies."

Crescendo eventually will launch other rheumatoid arthritis tests that can assess, for example, which drugs work best in specific patients, whether patients are at risk for cardiovascular disease or stroke, and whether patients might suffer structural damage. The company has long-term plans to develop tests for other autoimmune diseases managed by rheumatologists, such as spondylitis, Sjogren's syndrome, and lupus. "But we will not launch a new product in 2013," Hagstrom said.

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