A firm that has developed joint fluid assays for orthopedic and rheumatology practices has raised just about all of its $5 million target to bring its tests to market. The first test, scheduled to launch in August, is to detect infection.
Other tests being developed by CD Diagnostics will be rolled out next year, including tests for rheumatoid arthritis and gout. The company estimates the U.S. market for the test is more than 51 million.
In an interview with MedCity News, CEO Richard Birkmeyer said, “It is very exciting. We’re pretty pleased with progress we have made in the past year.”
Since Birkmeyer joined the company in March last year, the company has added 17 staff and expects to add another eight Ph.D.-level employees by the end of the year, consisting primarily of scientists and senior management.
“When you have inflammation in a joint, it can be a wide range of causes such as Lyme disease, gout, bacterial infection. Our test tells exactly what is causing that pain, no matter what the joint.”
The company is based at Lankenau Institute for Medical Research in Wynnewood, Pennsylvania, the incubator for Lankenau Hospital. The test takes about 10 minutes. A fluid sample is taken from the joint. Once in a collection chamber, the sample flows along a test strip and contacts specific antibodies, which are treated with an enzyme that will change color if a joint disease biomarker is present in the sample, according to the company’s website.
The color change indicates that the patient has the specific joint disease, depending on the disease for which he or she is being tested. It is designed to be more accurate than current joint fluid tests available because it measures the presence of protein biomarkers in the joint fluid around the relevant joint to avoid the potential for false positive or negative results.
Birkmeyer likens the point-of-care kits to a pregnancy test.
It has previously received backing from Ben Franklin Technology Partners of Southeast Pennsylvania, angel investors and the Lankenau Institute.
The company is applying for 510(k) clearance for the test and expects to get a CLIA waiver since the test conforms to the clinically approved laboratory improvement amendment.
Birkmeyer previously co-founded and ran Strategic Diagnostics (NASDAQ:SDIX), a biotechnology company with diagnostic tests for agricultural, industrial and water-treatment applications, and which also provided antibody research and development services.
The company is planning to move later this year to Delaware where it will manufacture the testing kits, but is still firming up the location. The state government is providing a $500,000 incentive, more than the $275,000 offered by Pennsylvania, according to an article in Delaware newspaper, The News Journal.
It has taken only two-and-a-half years to get to this stage, Birkmeyer said. Asked about the future of the company, he said: “Like all companies, we will be looking for an exit, but not for another three to four years.”
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