Diagnostic Technology

About TpP
Point of Care
Clinical Results

TpP POINT-OF-CARE

One of the key milestones for TpP in 1999 will be the application for a 510(k) FDA clearance for the point of care version of TpP. The point-of-care (POC) device offers the same benefits as the laboratory diagnostic test — unequalled ability to identify or rule out the formation of life threatening blood clots — but in a rapid, simple test that can be administered in an emergency room, at bedside, or in a doctor's office.

The POC test was developed through a collaboration between ABS and New Horizons Diagnostics. New Horizons, a respected designer of diagnostic devices, was honored for its work in building rapid tests for the US military to use during the Gulf War — tests used to detect the presence of pathogens, such as anthrax and botulism.

In 1999, the POC test will undergo rapid clinical evaluation in at least two centers, under the supervision of Dr. Yale Arkel, to verify its equivalence to the ELISA format. The results of those studies will then be submitted to the FDA for review and clearance.

Establishing the efficacy of this device is an important step in ABS' strategy of signing an agreement with a TpP licensing partner. While the laboratory ELISA version has demonstrated its value and flexibility in identifying the formation of blood clots, the POC test combines such assets with an ability to deliver results in a matter of minutes, where care is being provided. TpP POC's combination of speed, convenience and diagnostic accuracy make it an extremely attractive candidate for licensing to a large diagnostic/pharmaceutical company with global marketing reach.

 


American Biogenetic Sciences, Inc. ©2000