Therapy Areas: Devices
Anpac Bio wins US CLIA Lab certification for commercial laboratory in San Jose
27 September 2019 -

Biotechnology company Anpac Bio-Medical Science Co Ltd said on Wednesday that its US subsidiary Anpac Technology USA Co Ltd has received a certificate of registration for its commercial laboratory in San Jose, California under the US Clinical Laboratory Improvement Amendments of 1988, or CLIA.

The company has developed breakthrough, proprietary, 'Cancer Differentiation Analysis' (CDA) liquid biopsy technology that effectively reinvents cancer screening and early detection. Its proprietary CDA medical devices analyse simple, standard, non-invasive 'Blood Biopsies' -- resulting in measurably greater early cancer detection sensitivity and specificity, with no harmful side effects in patients.

To date, the proven results of 120,000 cases demonstrate CDA's research validity achieving an average sensitivity and specificity rate range of 75%-90% for 28+ different types of cancer, identifying the type and location of threatening, diseased cancer cells before they form into tumours, the company stated.

As of 30 June 2019, Anpac Bio had filed over 200 patent applications worldwide, with 116 granted, including 54 in greater China (including seven in Taiwan) and 16 in the United States.

In addition, the company has signed research agreements with US universities and academic medical centers and other health organisations to conduct research studies on its CDA technology in the San Jose laboratory.

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