Quest Diagnostics, the world's leading provider of diagnostic information services, has made availability of two new blood tests for aiding the early diagnosis of rheumatoid arthritis (RA), an autoimmune disorder that can cause debilitating joint damage.
The lab-developed tests are based on the proprietary 14-3-3eta protein biomarker through an exclusive license agreement for the US market with Augurex Life Sciences. One test provides results of 14-3-3eta blood levels, while a comprehensive panel provides results of blood levels of the novel marker as well as the conventional RA markers cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor (RF). Higher blood levels may suggest a greater likelihood of RA.
"These novel assays have significant potential to help physicians identify early stage RA, when treatment can often arrest further disease progression and disability," said Stanley J Naides, MD, FACP, FACR, medical director, Immunology R&D, Quest Diagnostics. "We believe they are superb examples of the potential of diagnostic insights to promote better outcomes through earlier diagnosis and treatment."
Diagnosis and initiation of treatment of RA within 12 weeks of symptom onset can help prevent joint damage, improve long-term function, and increase the likelihood of achieving disease remission. Yet, many patients are not diagnosed during this time frame, and conventional lab tests, which evaluate blood levels of CCP antibodies and RF, may fail to identify the disease in an early stage.
Physicians may consider results of RF and CCP antibody tests, along with a medical evaluation and X-rays, to diagnose RA. Elevated blood levels of the 14-3-3eta biomarker outperformed conventional RF or CCP antibody testing in a recent study of early RA, being positive in 60-82 per cent of patients diagnosed with RA compared to RF alone (32-82 per cent) or CCP antibody alone (44-82 per cent). The combination of all three markers further increased sensitivity to 72-100 per cent. In addition, co-morbid conditions, such as type 1 diabetes, osteoporosis and gout, do not abnormally raise blood levels of 14-3-3eta.
"The key to successful treatment of rheumatoid arthritis rests with early diagnosis so that appropriate treatment can be instituted before the appearance of joint damage. We still lack the ability to diagnose this disease early in a substantial proportion of patients who may not then receive timely care. The introduction of 14-3-3eta therefore fulfills an important unmet need for both rheumatologists and primary care physicians," says Dr Walter Maksymowych, the principal investigator of several 14-3-3eta studies as well as the International Chair of the Outcomes Measures in Rheumatology Clinical Trials Soluble Biomarker Subcommittee and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada.
"There are multiple routes that biotechnology companies like Augurex can take to commercialize scientific discoveries for clinical use. We believe that Quest's expertise in immunology and leading diagnostic services position is the best way for 14-3-3eta to reach US physicians and patients who can benefit most from it," says Norma Biln, chief executive officer of Augurex, which announced the license agreement with Quest Diagnostics in October 2012.
Quest Diagnostics' advanced clinical laboratory in San Juan Capistrano, California, developed, validated and now offers the new RA tests.
Quest Diagnostics offers a broad menu of immunology diagnostic-information services, including a full menu of diagnostic tests for immune function and autoimmunity.