A: Only a confirmatory procedure such as biopsy evaluation by a pathologist may be used to diagnose NPC. NP Screen™ is a way to screen which is used exclusively to detect NPC and assess a patient’s need for a confirmatory procedure such as biopsy.
A: NP Screen™ can only detect and assess a patient’s current risk for NPC and can not predict future abnormalities.
A: NPC can only be cured by one of, or a combination of, radiation therapy, chemotherapy or surgery.
A: How rapidly NPC develops is not completely understood. Doctors experienced with NPC believe it takes six to twelve months for newly formed abnormalities to appear and become a clinical risk.
A: Similar to tests for cervical cancer, breast cancer and prostrate cancer, NP Screen™ should be taken regularly and can be done on a yearly basis. In patients with a predisposition (i.e. genetic or family background) for NPC, semi-annual testing may be considered because treatment outcome depends on early detection.
A: Healthy, cancer free patients may report no, to very low, transient, abnormality levels, which is considered normal.
A: NP Screen™ is a Laboratory Developed Test (LDT) approved under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”). The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. The performance characteristics for NP Screen™ were established through validation by Primex Clinical Laboratories which is regulated under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) as qualified to perform high complexity clinical testing.
This test is patent protected and may only be performed as a service by Primex Clinical Laboratories, Inc via NP Screen™, Inc.