David Alland

Xpert MTB/RIF (Xpert) assay is a PCR-based assay used for automated TB detection and detection of resistance to the drug Rifampicin (RIF). However drug resistance detection is limited to identifying patients who potentially have MDR, but cannot tell whether a patient with RIF resistance remains INH-susceptible, and thus could still be treated with an INH-containing regime. Nor can it identify which RIF-resistant patients can be treated with a FQ and/or aminoglycoside as opposed to those who have XDR TB. Thus, patients are at risk for being either over treated or undertreated, with potentially serious consequences. Furthermore, patients with undiagnosed XDR can remain infectious for prolonged periods, further spreading their disease. This grant funds the development of a new “Xtend-XDR” assay that will complement the current Xpert assay, making it possible to select appropriate treatment (and infection control) approaches in patients identified with TB. The Xpert assay is marketed by Cepheid and based on RU patents. Cepheid pays licensing fees to RU as part of a patent pool for the use of molecular beacon technology patented by Rutgers. In addition, there are two pending Rutgers University patent applications on probes and primers to detect drug resistance in Mtb. Some of the probes and primers are being used in the assay being developed in the current study. Dr. Alland benefits from the development of this technology through his share of license fees paid to Rutgers on his behalf.