Research

What Research has been done?

NP Screen™ has been in development since 2000 and approved in 2008 as a screening kit and laboratory protocol for the detection of nasopharyngeal carcinoma in high risk populations using EBV DNA amplification methodology under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”).

The initial 5 to 6 years was devoted particularly to a highly reproducible in-vitro DNA assay for detection of Epstein-Barr Nuclear Antigen-1 gene (EBNA1) in human specimens collected from the posterior nasopharyngeal epithelium using a developed trans-oral nasopharyngeal brush and brushing methodology. The test was developed in a single laboratory, using real-time polymerase chain reaction on an ABI Prism SDS Platform using NP Screen™ specifications. A proprietary transport buffer was ISO developed for the transport of epithelial brushings at room temperature and has been found to be stable for a prolonged time interval which enables the transport of specimens by mail carrier service.

Clinical trials in Canada and Hong Kong confirm that normal patients present negligible EBV DNA levels in the brush samples while test results from NPC patients indicate significantly higher EBV DNA levels. A statistically significant difference in EBV DNA counts between NPC positive and negative patients have been confirmed. The cutoff levels correlating between positive and negative NPC was established.

Clinical Studies

the-university-of-hong-kong

Queen-Mary-Hospital-Hong-Kong

Study 1:

NP Screen™ is excited to announce supporting a study designed by Dr. Dora Kwong, Head of Department of Clinical Oncology at Hong Kong University. Dr. Kwong will perform a prospective study to follow post-radiation NPC patients to assess
NP Screen™’s ability to diagnose the recurrence of NPC as compared to clinical assessment and Plasma EBV DNA. The total study will involve 20 patients and is expected to take 3 years to complete.

Study 2:

NP Screen™ is excited to announce supporting a second study designed by
Dr. Dora Kwong, Head of Department of Clinical Oncology at The University of Hong Kong . Dr. Kwong will perform a prospective study on patients diagnosed histologically as having recurrent NPC. A NP Screen™ brushing will also be performed to assess the sensitivity and specificity of NP Screen™ for detection of recurrent disease.

Study 3:

NP Screen™ is excited to announce supporting a second study designed by
Dr. Raymond King-Yin Tsang, Clinical Assistant Professor, Department of Surgery at The University of Hong Kong. Dr. Tsang will perform a study on detecting local recurrence in nasopharyngeal carcinoma by EBV DNA level in nasopharynx obtained by using transoral brush biopsies. A NP Screen™ brushing will also be performed to assess the sensitivity and specificity of NP Screen™ for detection of recurrent disease.

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