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Clongen Laboratories Forms Separate Clinical Dx, Contract Research Branches


Clongen Laboratories, a Maryland-based CLIA-licensed testing facility, said this week that it has recently formed separate divisions for clinical diagnostics and contract research services.

Clongen's clinical diagnostics division specializes in screening a wide range of infectious diseases, primarily using real-time PCR. The Germantown-based company has historically focused on testing for tick-borne illnesses, but said that it also now offers more than 250 infectious disease assays, some of which are not offered anywhere else in the US.

The company's contract research services division offers a wide range of assays under GLP and GMP conditions to pharmaceutical, biotechnology, government, and academic institutions, the company said.

Services in this division include sterility testing, Mycoplasma detection and elimination, and endotoxin testing and removal. Clongen said that it has also recently developed rapid real-time PCR-based assays to detect all biowarfare select agents listed by the US Centers for Disease Control and Prevention.

Clongen said that it expects to soon receive CLIA licensure in five additional states beyond Maryland, and that it is establishing satellite facilities in several other states.

Founded in 1999 in Mountain View, Calif., as a biotechnology business consulting firm, Clongen established its Germantown laboratories in 2004 for clinical diagnostic testing.

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