One of the many challenges of a rheumatoid arthritis diagnosis is the condition’s variability from patient to patient and over time. This unpredictability also impacts the effectiveness of drugs used to treat the disease. One company has developed a molecular test using a biomarker and an app to collect data to help physicians and patients make more informed choices about medications.
Crescendo Bioscience launched the Vectra DA biomarker blood test in 2010. In an interview with MedCity News, William Hagstrom, the CEO, said the test provides a baseline for patients to give doctors a better view of the level of the disease in each patient.
“There’s a particularly acute need for innovation on the therapy side because with nine approved drugs in the biologics class, there’s a lack of sophisticated tools to allow physicians to understand what patient needs which drug at what dose. Our belief is having a great tracking system will lead to more patients being successfully managed to remission and improved outcomes.”
About 1.5 million in the U.S. were diagnosed with rheumatoid arthritis as of 2005, according to the Centers for Disease Control and Prevention.
The Vectra DA test ascertains the presence of 12 biomarkers not only to confirm a diagnosis of rheumatoid arthritis, but to assess the level of the disease in the patient. The test gives a score between 1 to 100 — the lower the number the lower the disease activity. Using the test, doctors can determine whether there is joint erosion, bone erosion or cartilage breakdown. The diagnostic is backed by a Web portal called Vectra View that helps doctors view all patients under their care to manage the patients’ disease level. Because rheumatoid arthritis patients need to visit their physicians regularly, they can track the disease level over time.
The company developed an iPhone app called MyRA to improve patient engagement and interaction with physicians. Users can flag parts of the body and make notes. They can also click on an image to show how they are feeling day to day. The app also helps users generate a visual summary report tracking their data so patients and their doctors can see how they’re doing between visits.
In the next version of MyRA, Hagstrom said the company plans to integrate Vectra View data so patients have access to the same information as the physician. The company also plans to integrate data collected from Vectra View in to patients electronic medical records so it can be viewed in context with other information.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Hagstrom said pharmaceutical companies are also interested in Vectra DA because it allows them to see what the response to a particular therapy looks like. With more than 60 drugs in various stages of development, the tool offers pharmaceutical companies a high level of insight into the dose effect, which will become even more critical with so many more drugs potentially entering the market.
The test platform also offers something for payers. Rheumatoid arthritis is a costly disease to treat and, like many chronic conditions, it consumes a disproportionate amount of money relative to other conditions. With the plan to shift reimbursement to outcomes-based care, the test supports the view that increasing data could lead to a greater number of patients achieving remission. Although it’s had success securing reimbursement with private payers, Crescendo is working on getting Medicare coverage for the test.
One long-term goal for the company is to use its tracking technology to develop a diagnostic test to determine what’s the best drug in a biologics class that’s most suitable for each patient.
The next step for the company is market expansion. Hagstrom started off as the first employee of the company and it has since grown to 100 people with plans to add more later this year to access 90 percent of rheumatologists in the U.S.
It plans to use the $28 million raised in a series D financing round led by Safeguard Scientifics (NYSE:SFE) and Skyline Ventures earlier this month to advance commercialization of the test. As part of the investment, Gary Kurtzman, a managing director with Safeguard, joined the company’s board of directors. In an emailed statement, he observed that the Vectra test reflects an unmet need.
“The continued convergence of healthcare and technology has fostered diagnostic innovations that can streamline elements of the healthcare system, identify more accurate therapies and ultimately reduce costs.”
