CD Diagnostics (Wynnewood, Pa.) completed the purchase of Citrano Medical Laboratories (Towson, Md.), a family-run Clinical Laboratory Improvement Amendments-certified laboratory, in October as a final step in readying the company to launch its first tests. The company’s synovial fluid-based assays are aimed at improving diagnosis of joint conditions and will initially target detection of infections. The company says that 51 million people are tested annually for joint pain resulting from an infection, osteoarthritis, gout, or other disease. Synovial fluid samples offer greater specificity than blood to detect the cause. CD Diagnostics’ assay employs a lateral flow design and uses antibody-coated cellulose strips to analyze the joint fluid. While initially launching as a lab-developed test, the company will pursue 510(k) clearance to approve the test as a moderately complex point-of-care test (results are read in 10 minutes, much like a pregnancy test). The company hopes to receive regulatory approval in 2014. Richard Birkmeyer, Ph.D., the CEO of CD Diagnostics, tells DTTR that the case for the test is pretty straightforward. Joint fluid is currently analyzed with a series of tests that can include culture, gram stain, and C-reactive protein, which is not specific to joint infections culture, as well as expensive […]
CD Diagnostics (Wynnewood, Pa.) completed the purchase of Citrano Medical Laboratories (Towson, Md.), a family-run Clinical Laboratory Improvement Amendments-certified laboratory, in October as a final step in readying the company to launch its first tests. The company’s synovial fluid-based assays are aimed at improving diagnosis of joint conditions and will initially target detection of infections.
The company says that 51 million people are tested annually for joint pain resulting from an infection, osteoarthritis, gout, or other disease. Synovial fluid samples offer greater specificity than blood to detect the cause. CD Diagnostics’ assay employs a lateral flow design and uses antibody-coated cellulose strips to analyze the joint fluid. While initially launching as a lab-developed test, the company will pursue 510(k) clearance to approve the test as a moderately complex point-of-care test (results are read in 10 minutes, much like a pregnancy test). The company hopes to receive regulatory approval in 2014.
Richard Birkmeyer, Ph.D., the CEO of CD Diagnostics, tells DTTR that the case for the test is pretty straightforward. Joint fluid is currently analyzed with a series of tests that can include culture, gram stain, and C-reactive protein, which is not specific to joint infections culture, as well as expensive radiographic assessments. Simple analytic assays for joint fluid analysis are currently lacking, Birkmeyer says. While declining to pinpoint a specific price for the test, Birkmeyer says the company is in talks with insurance companies and Medicare and expects the test to be reimbursed in the neighborhood of $40 to $80, a “dramatic” cost savings from current diagnostic methods.
The synovial test, which launched as a pilot program in November, tests for infection in artificial joints and is the first released under a development agreement between CD Diagnostics and Zimmer (Warsaw, Ind.). The agreement includes development of a total of four diagnostic products. CD Diagnostics receives milestone payments of roughly $3 million per test developed. A similar test for infections in native joints is expected to be available in February or March of 2013. The company anticipates completing 300,000 infection tests in the first year.
