Phadia US (Portage, Michigan) reported late last week that the FDA has cleared EliA CCP, which is the only fully automated assay for the measurement of cyclic citrullinated peptide antibodies, with the company calling these a highly specific indicator in the blood for rheumatoid arthritis (RA), an autoimmune disease.
The test expands on the offerings of Phadia U.S., a division of Phadia AB (Uppsala, Sweden), specifically in allergy testing. These offerings include the ImmunoCAP specific immunoglobulin E (IgE) blood test to test for allergens.
“The availability of [the EliA CCP] will offer healthcare providers a more accurate tool to diagnose this debilitating condition at an early stage in the disease compared with older testing methods,” said Michael Land, president/general manager of Phadia US. “Diagnosing rheumatoid arthritis early is critical to effectively treat the condition before it progresses and causes permanent joint damage.”
Patients with RA have periodic flare-ups that can lead to irreversible joint destruction if misdiagnosed or left untreated, the company said.
The EliA CCP assay uses a small sample of blood from a patient, which is then sent to a lab and analyzed for CCP levels through a CLIA moderate complexity test. The test is available on the ImmunoCAP 100 and 250, which the company said are two fully automated systems for autoimmune and allergy testing. The EliA system needs calibrating only once a month, the company said.
Historically, Phadia said, physicians have diagnosed RA through the use of “older and less effective” laboratory tests, clinical history and physicial examination using the disease classification criteria established by the American College of Rheumatology (Atlanta).
The EliA CCP assay’s specificity in RA patients is “greater than” 96%, the company said.
“Furthermore, a positive CCP measurement provides the greatest prognosis of eventual disease severity in a patient,” the company said.
Martin Mann, regulatory affairs manager for Phadia US, told Medical Device Daily that the EliA company (Freiburg, Germany) was purchased by Phadia in 1997. And the EliA CCP is the first test that will be offered in the U.S. under the EliA brand name, he said. Phadia AB includes the Autoimmunity Center of Excellence (Freiburg), which is part of Phadia AB.
“EliA products have been adapted for use on [Phadia’s] allergy equipment,” he said.
For the U.S. market, the EliA CCP assay has been in the works for about 18 months, Mann told MDD, adding later that “the only issue really is getting them cleared in the U.S.”
Currently, the company has pending before the FDA a test for Celiac disease and projects receiving clearance for it before year’s end.
Celiac can be extremely difficult to diagnose, Mann said. “[Celiac disease is] a cross between allergy and autoimmunity. It’s not classic autoimmunity, and it’s certainly not your classic allergy.”
With Celiac disease, a person’s body produces a “secretory antibody” to a foreign antigen, which then works against the person’s own tissue. People who have the disease must eat gluten-free products, or commonly described as wheat-free.
Next year, Phadia US will begin submissions for tests for “more classic” autoimmune diseases, Mann said.
Phadia US has about 50 employees at its U.S. headquarters in Portage, with “various” numbers of field personnel, some of whom are contract employees.
“We’ve got sales reps and clinical consultants who actually talk to physicians through a classic pharma model to get them to recognize ImmunoCap,” Mann said, “and they’re fully devoted right now to ImmunoCap to get that incorporated into [physicians’] daily diagnosing regimen for those with allergy-like symptoms.”
He said that the IgE test is available at “almost every major lab, with the exception of LabCorp [Laboratory Corporation of America; Burlington, North Carolina].”
And the company has a “formal marketing agreement” with Quest Diagnostics (Lyndhurst, New Jersey), he said.