The disclosure comes almost a year after Calando Pharmaceuticals published phase I data demonstrating that its own cancer drug CALAA-01 could knock down its intended target mRNA and protein inside a tumor through an RNA interference mechanism when delivered intravenously into humans.
FAP is an inherited, colorectal cancer syndrome characterized by the growth of colorectal polyps. Though the polyps are initially benign, they become malignant in nearly all cases in the absence of colectomy, according to Marina.
Despite a recent publication questioning the clinical validity of the KIF6 gene variant to predict risk of coronary heart disease and statin benefit, Celera has filed a PMA with the FDA and is embarking on a global commercialization strategy for the test.
The phase I drug, ALN-VSP02, comprises two siRNAs, one targeting vascular endothelial growth factor and one targeting kinesin spindle protein, both of which the firm said are critical for the growth and survival of cancer cells.
Until now, the FDA has not publicly stated that it intends to issue two separate guidances on Rx/Dx development: one focusing solely on advancing companion tests, and another document on how to gain regulatory approval for a drug and test simultaneously.
While payors speaking at a recent conference seemed to be of the opinion that personalized medicine lacks the evidentiary support to justify broad coverage, they suggested that CER may be a way to gather the necessary data on whether to reimburse for genomically guided medicines.
The new platform, called Panther, is expected to help Gen-Probe capture market share in the area of molecular testing at mid- and low-volume clinical laboratories, clinics, and physicians' offices as it competes with platforms from companies such as Roche, Qiagen, Cepheid, and Becton Dickinson.