Devices & Diagnostics

Diagnostics startup with joint fluid tests buys CLIA-certified lab, more acquisitions could follow

A diagnostics startup with tests that can identify infections in joints and joint replacements has acquired a CLIA-certified laboratory to accelerate the commercialization of its lead test. It is also eyeing two more deals with laboratories that do medical diagnostic and point-of-care tests, CD Diagnostics CEO Richard Birkmeyer told MedCity News in a phone interview. […]

A diagnostics startup with tests that can identify infections in joints and joint replacements has acquired a CLIA-certified laboratory to accelerate the commercialization of its lead test. It is also eyeing two more deals with laboratories that do medical diagnostic and point-of-care tests, CD Diagnostics CEO Richard Birkmeyer told MedCity News in a phone interview.

The acquisition follows a $5 million financing round earlier this year. The laboratories that CD Diagnostics may or may not acquire by the end of the year are both located in the mid-Atlantic region. The move could impact its plans to relocate to a Delaware facility.

The Wynnewood, Pennsylvania-based firm’s first test, an immunoassay to diagnose infection in joint replacements, is expected to be launched next month. It is acquiring the suburban Baltimore-based Citrano Medical Laboratories, a laboratory with a portfolio of testing services such as hematology and urinalysis that can provide same-day results six days per week to its clients, according to a press statement. It also adds to the firm’s research and development clout.

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It expects to announce a corporate partner to commercialize the test in November. It expects to introduce the joint replacement infection test in Europe next summer. It hopes to secure 510(k) approval for both of its joint tests in the U.S. that could be used by physicians in their offices, emergency rooms and operating rooms in 2014.

Joint inflammation can be triggered by a wide range of things. The company sees significant market potential as more than 51 million people are tested annually for some type of joint pain from an infection, osteoarthritis, gout and other diseases.

It recently beefed up its management team with three hires: Anne Cavanaugh, vice president of corporate development, and Keith Kardos, vice president of research and development, were hired over the summer, and Connie Viering, vice president of operations, joined this week.

The company is looking to fill three job openings: one for a Ph.D.-level scientist, an administrative level position and a sales and marketing job.

The Clinical Laboratory Improvement Amendments, or CLIA certification, were passed by Congress in 1988 to ensure that every lab that carries out tests on human samples is certified.

Birkmeyer has likened the diagnostic to a home pregnancy test — it 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 changes 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. The test is designed to be more accurate than current joint fluid tests available because it measures the presence of biomarkers in the joint fluid around the relevant joint to avoid the potential for false positive or negative results.

In addition to the joint infection test, it is also working on tests to detect gout and osteoarthritis.

 

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