Matritech’s Nuclear Matrix Protein (NMP) technology basically refers to a series of quantitative enzyme immunoassays that detect proteins present in the nucleus of malignant or pre-malignant cells. NMP technology (NMP22) has already been successfully applied to bladder cancer to identify bladder cancer patients who are at risk for rapid recurrence or occult disease.

The screening of women for cervical cancer has dramatically reduced the burden of illness associated with this disease. Matritech estimates that approximately 150 million cervical cell samples are tested and analysed annually worldwide. The American Cancer Society estimates that in 2004, 10,520 cases of cervical cancer will be diagnosed in the United States – a decline of over 70% since 1955. However, current screening tests for cervical cancer do rely on a somewhat subjective review by a cytotechnologist of a fraction of cells collected. Matritech contends that these factors necessitate the development of an automated system for detecting disease.

Due to the high volumes associated with cervical screening programs in most health services organizations, emerging screening and diagnostic technologies, if proven effective, have the potential to become High Impact. Biohorizon is currently monitoring 5 emerging diagnostic tests for this disease indication. Given the limited data Matritech has released to date, it is simply too early to determine how and where NMP179 will fit in cervical screening programs if approved. Biohorizon currently recommends no preliminary assessment activities for this emerging diagnostic test.

Technology Details
Target Disease / Indication: Cervical Cancer
Technology Classification: Diagnostic Test
Body System: Genitourinary System
Program Area: Gynecology
Regulatory Status: Investigational
BioHorizon Impact Score: 61/100 – Moderate

The FDA-approved OraSure® Oral Specimen Collection Device is a generic device developed for the purpose of collecting, preserving, and transporting oral fluid specimens. It uses a simple, two-minute collection procedure that can be performed by any trained personnel. OraQuick Rapid Antibody Test has been approved for the detection of antibodies to HIV-1 in oral fluid gathered by this device as well as the detection of antibodies to both HIV-1 and HIV-2 in plasma samples. The FDA has required OraSure Technologies to perform certain post marketing studies.

There are an estimated 65 million HIV tests performed in the United States annually. The cost of testing with OraQuick is estimated at somewhere between 8 and 20 dollars per test. Positive tests must be confirmed by follow-up tests as per existing screening tests.

Point of care diagnostic testing for HIV, and the option for the use of oral fluid versus blood as the specimen of choice, make for a potent combination when it comes to the predicted rate of diffusion of OraQuick Rapid Antibody Test. The potential for this test to transform HIV screening in the United States certainly exists. At the present time, Biohorizon has designated OraQuick as a Moderate Impact Technology as it does not significantly increase the cost of treatment/diagnosis per patient, a requirement for the High Impact Technology designation. However, Biohorizon does recommend that clients with significant HIV screening exposure commence assessment activities.

Technology Details
Target Disease / Indication
HIV

Technology Classification
Diagnostic Test

Body System
Multiple Systems

Program Area
Medicine/Infectious Disease

Regulatory Status
Approved

BioHorizon Impact Score
56/100 – Moderate