GenWay Biotech Obtains CLIA Certification

Main Category: Pharma Industry / Biotech Industry
Article Date: 16 Jul 2009 - 0:00 PDT

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GenWay Biotech, Inc., a US-based diagnostic company has become CLIA certified and received a California lab license. Their license currently permits the testing of immunological biomarkers. This is a very important step in the direction of commercialization of the novel innovative diagnostic tests currently being developed at GenWay. In upcoming weeks, GenWay will add new cancer biomarker tests to their portfolio as well as several infectious diseases such as sexual transmitted diseases. GenWay is seeking to obtain CAP accreditation by the end of the year.

Dr. Joe Voland, CLIA Pathologist and lab director, claims that he has never seen a CLIA lab get set up so efficiently and professionally as GenWay has done. GenWay Biotech Inc. is a GMP compliant facility with capabilities for research, development and manufacturing of proteins, antibodies, immunoassays, and diagnostics. Consequently, most quality control and assurance measures were already in place facilitating the transition into a CLIA certified laboratory. Furthermore, GenWay's lab is under construction for the addition of a Class 10,000 clean room which should be complete sometime in August 2009.

Dylan Malayter, Project Manager, who has played a predominant role in guiding the lab through the CLIA certification process, feels "This is an immense step forward for GenWay Biotech, Inc. We are excited to begin accepting patient samples and performing revolutionary tests that may save patients lives and enhance their treatment by monitoring their condition with simple non-invasive blood tests."

The GenWay team is looking forward to the future impact of the cancer biomarker tests they will offer. They have secured exclusive rights to the DR-70 test from AMDL and have secured several other biomarkers in the field of cancer diagnostics.

Source:
Dr. Jill Dombrauckas
GenWay Biotech

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