Drug Response Assays
IRINOTECAN
Nuclea has identified gene and protein expression profiles that may be utilized in an assay to determine if a patient is a responder or non-responder to treatment with irinotecan prior to therapeutic administration. Nuclea's method comprises obtaining a sample from the patient, creating the gene and protein expression profile of the sample, and determining from the gene or protein expression profile whether at least one irinotecan responder gene or protein is over-expressed or under-expressed in the sample. From this information, the treatment provider can ascertain whether the patient is likely to benefit from irinotecan therapy.

Nuclea possesses antibodies specific for each of the proteins in the gene and protein expression profiles. These antibodies are marked with detectable labels which can be used with an automated IHC instrument. The test may be used with tissue MicroArrays containing several hundred patient tumor samples to simultaneously determine responsiveness to irinotecan. This method is more user-friendly, less time consuming, and may provide a higher degree of accuracy than methods reliant on detection of nucleic acid expression requiring amplification (such as RT-PCR). Preliminary tests on archival samples from patients who were responders to irinotecan therapy indicate that the test is highly sensitive and specific in identifying responders versus non-responders.


EGFR-Inhibitors
Nuclea has identified gene and protein expression profiles may differentiate responders versus non-responders to treatment with therapeutics that inhibit EGFR activity. These expression profiles may allow treatment providers to identify those patients who are responders to treatment with compounds that inhibit the intracellular phosphorylation of EGFR-associated tyrosine kinase, including Iressa and Tarceva, and those who are non-responders to such treatment. Preliminary data suggest this test is highly sensitive and specific in identifying responders versus non-responders.