Company expects to complete clinical validation studies by April 2009.
Gene Express is licensing certain gene-expression technologies from the University of South Florida (USF) to develop tests for cisplatin and irinotecan chemoresistance. The firm believes that it will submit a prognostic test to the FDA for approval in the first half of next year.
The deal, signed with the Division of Patents & Licensing Research Office at USF, includes the ERCC1 and RRM1 genes. USF researchers say that they have discovered a correlation between expression of ERCC1 (excision repair cross-complementing-1) and the survival of patients with non-small-cell lung cancer (NSCLC). They also found that RRM1 is a clinically important determinant of malignant behavior in NSCLC.
“By adding these genes to our growing collection of gene standards, we will be able to develop the most accurate, sensitive, and reproducible molecular diagnostic tests for identifying tumors that are resistant to specific chemotherapeutics,” remarks Jonathan D. Rowe, Ph.D., svp of strategy and clinical innovation for Gene Express.
Gene Express intends to complete clinical validation for correlation of gene expression versus chemoresistance for cisplatin treatment by April 2009 and submit a 510K class II prognostic test to the FDA by May 2009. The company anticipates receiving approval of the 510K medical prognostic test in August 2009 and commercial application completed by December 2009.