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NPC is one of the leading causes of cancer deaths among ethnic Chinese with a life-time risk for developing NPC of 1 in 53 for males and 1 in 131 for females. The annual mortality for this cancer exceeds 50,000 annually, a tragic statistic because NPC can be cured when detected early.
The prognosis for NPC is significantly dependant on the extent of disease at diagnosis. Most NPC becomes clinically evident during the advanced stage and less than half of those diagnosed survive. NPC develops silently, few if any symptoms are noticed during the early and intermediate stages of the disease making routine screening with effective screening tools essential for surviving NPC. Unfortunately, there exists no accepted or widely promoted population based screening programs for NPC. Historic NPC screening techniques are either inaccurate or complex requiring local anesthetic applied to the nasal passages for fiberoptic nasopharyngoscopy (nasal-endoscopy) screening, which is available only by referral to an Otolaryngologist/ENT surgeon. Limited by its invasive nature and availability, nasal-endoscopy is not ideal for screening NPC in the asymptomatic patient.

NP Screen® assay is a simple, straight forward genetic screening test for the detection of NPC bio-markers in DNA samples isolated from specimen collected from the anatomic local where NPC first forms, in this way NPC may be detected very early. Because the NP Screen® assay is patient-friendly it is expected to improve patient acceptance of routine screening and markedly advance efforts to detect and treat the disease early in development when outcomes and quality of life are significantly better.
A LTD (laboratory developed test) version of NP Screen® assay has been commercially launched in U.S.A and Canada on a limited basis by Primex Clinical Laboratories, Inc. and since that time it has served to aid in the diagnosis of asymptomatic patients whose cancer detection and treatment may have been delayed for a year or more and, also served to clear clinical uncertainty for normal patients who might have otherwise undergone an invasive biopsy procedure with possibility of complications. In conjunction with the commercial launch of the LDT version, additional clinical trials will be held to support a Pre Market Approval submission to the FDA. This approval will facilitate the distribution of the NP Screen® assay to other parts of the world.
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