What is rheumatoid arthritis (RA) and how has it traditionally been diagnosed?
Rheumatoid arthritis (RA) is an autoimmune disorder that can cause debilitating joint damage. In cases of RA, the immune system attacks the body’s own tissues, especially the membranes that line the joints. As a result, fluid builds up in the joints, causing pain and systemic inflammation, leading to joint destruction if untreated.
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 may fail to identify the disease in an early stage.
At what stage is RA normally diagnosed?
Unfortunately, patients often delay seeing their physician when signs of RA first appear. Achiness and joint stiffness can be attributed to lifestyle factors or simply overlooked.
Once the patient sees his/her physician, the assessment begins with a medical history and a physical examination by a physician, who will look for certain features of RA.
Traditionally, this assessment was followed by certain blood tests to identify antibodies and possibly X-rays to identify bone loss at the edge of joints as well as loss of joint cartilage.
Depending on the length of time spent prior to evaluation and while waiting for definitive test results, irreversible damage can be happening to the body.
Why do conventional lab tests fail to identify RA at an early stage?
Conventional lab tests, which evaluate blood levels of cyclic citrullinated peptide (CCP) antibodies and rheumatoid factor (RF), may fail to identify the disease in an early stage.
Quest Diagnostics recently introduced a novel lab test that offers increased sensitivity and has significant potential to help physicians identify early stage RA, when treatment can often arrest further disease progression and disability.
Why is early diagnosis beneficial?
Although there is no cure for RA, highly effective treatments exist. The key to effective treatment is to begin it early in disease onset.
Once diagnosis is established, treatment should be started immediately to slow disease progression and lower chances for joint damage.
Updated medical guidelines recommend early treatment with DMARDS (disease modifying anti-rheumatic drugs) much earlier than in the past, often along with NSAIDs and corticosteroids. These therapies can be very effective in slowing the progression of RA, but they are most effective when started within 12 weeks of the onset of symptoms.
Please can you outline the two new blood tests for aiding the early diagnosis of RA recently made available by Quest Diagnostics?
The 14-3-3eta lab-developed test is based on the 14-3-3eta protein biomarker through an exclusive license agreement in the United States 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 CCP antibodies and RF.
Physicians may consider results of RF, CCP antibody and 14-3-3eta tests, along with a medical evaluation and X-rays, to diagnose RA.
Quest Diagnostics already provides the RF and CCP antibody tests, and a panel that incorporates these assays as well as 14-3-3eta has certain advantages, including potentially higher sensitivity for detecting RA, than any of the three markers can provide alone. A panel also allows a physician to test a patient only once and receive a single report.
This “one blood draw, one report” approach is significantly more convenient for the patient and clinician in those cases where a physician may believe consideration of results of all three tests would aid diagnosis.
On the other hand, a physician may not believe results of all three tests are required for a reliable diagnosis or perhaps a patient received certain tests already, perhaps under care of a different doctor, and additional testing would be redundant and unnecessary. In these cases, single tests may be more appropriate.
How do these novel tests allow for early diagnosis of RA?
Research shows that elevated blood levels of the 14-3-3eta biomarker outperform conventional RF or CCP antibody testing for RA. When physicians consider results of all three markers, the sensitivity improves even further.
In addition, co-morbid conditions, such as type 1 diabetes, osteoporosis and gout, do not abnormally raise blood levels of 14-3-3eta.
How do these tests compare to others on the market?
Only Quest Diagnostic provides the 14-3-3eta single and panel tests in the United States. Quest Diagnostics serves about half of the physicians in the United States. Patients interested in these tests should ask their physician for additional information.
What impact do you think these tests will have?
We’re proud that these tests will provide critical information that can potentially benefit thousands of individuals at risk for RA. Our expertise in immunology and leadership in diagnostic information services mean we are well positioned to provide superior RA diagnostics services to physicians and patients.
How do you think the future of RA diagnostics will develop?
We believe these new tests are the most advanced diagnostic tool available to physicians and patients. But more can be done to advance diagnostics for patients at risk for RA.
In the future, diagnostic companies like Quest Diagnostics may be expected to focus on opportunities to develop diagnostics for improving detection at early stages and companion tests to help personalize therapy for RA drug treatments.
What are Quest Diagnostics plans for the future?
One of the central tenets of the strategy of Quest Diagnostics is to focus on developing and offering diagnostic innovations along a continuum of care. These advances should serve an unmet clinical need, be based on clinical evidence and help complete gaps in guideline-based care.
We are particularly interested in diagnostics that can help prevent or arrest disease – that is, diagnostic services that can help identify risk factors for disease, thereby potentially helping physicians to prevent its onset, or disease in early treatable stages. Disease prevention is the best possible outcome of any healthcare service.
Our new RA test and panel are consistent with our larger strategy because they address a significant gap in the continuum of care of RA – namely the ability of physicians to reliably detect early-stage RA. This is important because early diagnosis and treatment correlates with better outcomes.
Where can readers find more information?
Please visit our website at QuestDiagnostics.com.
About Dr. Naides
Stanley J. Naides, M.D., F.A.C.P., F.A.C.R., is medical director, Immunology R&D, at Quest Diagnostics.
Quest Diagnostics, the world’s leading provider of diagnostic information services that patients and doctors need to make better healthcare decisions, offers a broad menu of immunology diagnostic-information services, including a full menu of diagnostic tests for immune function and autoimmunity.
Dr. Naides received a bachelor’s degree from Princeton University where he majored in biochemistry. He studied medicine at Hahnemann University, and trained in internal medicine at the University of Miami / Jackson Memorial Hospital and Temple University.
He completed fellowships in rheumatology at the University of California, San Diego and in immunology research at Harvard Medical School.
He is certified by the American Board of Internal Medicine with subspecialty certification in rheumatology.
Dr. Naides’ research has been funded by the National Institutes of Health, Veterans Administration, Arthritis Foundation, Lupus Foundation, American Philosophical Society, March of Dimes, Children's Miracle Network Telethon, Schwartz Foundation, and pharma.
Dr. Naides is based at the Quest Diagnostics Nichols Institute in San Juan Capistrano where he continues to conduct research on autoimmune disease and oversees esoteric laboratory testing in Immunology, including rheumatoid arthritis testing.