A Medical Device Daily

Panacea Pharmaceuticals (Gaithersburg, Maryland) reported launch of a new business, a CLIA-compliant diagnostic testing laboratory named Panacea Laboratories, to provide blood, serum and tissue tests to diagnose and monitor cancer.

It said the laboratory's first test, TK Sense, measures expression of the gene encoding Human aspartyl (asparaginyl) Beta-hydroxylase (HAAH) in leukocytes in patients with Chronic Myelogenous Leukemia (CML) to identify those patients unlikely to respond to therapeutic treatment with imatinib mesylate (Gleevec). Although the molecular hallmark of CML is a mutation in a gene known as BCR-ABL, mutations to the ABL portion of the gene do not reliably predict response to Gleevec therapy.

It said future products will include serum tests to diagnose and monitor prostate, liver, lung, cervical and other cancers.

Panacea said it has discovered that expression of the gene encoding HAAH significantly decreases when leukocytes from patients with CML are cultured in the presence of imatinib. This decrease in HAAH gene expression level correlates with drug response. Patients not responding to imatinib treatment do not show a decrease in HAAH expression in the assay.

"Gleevec has become recognized as the most effective non-transplant treatment available for patients with CML," said Stephen Keith, MD, president and chief operating officer of Panacea. "However, it is an expensive drug [ranging] from $30,000 to $40,000 per year. Clearly, identifying patients with a low likelihood of responding to Gleevec may avoid potentially serious adverse effects, hasten the initiation of potentially more beneficial treatment, and save considerable costs."

Panacea said it also has developed a quantitative measurement of HAAH in human serum. It said preliminary results have determined a specificity of 97% (n=230) and a sensitivity of 94% (n=85) as indicated by significantly elevated serum HAAH levels for a series of cancers including breast, ovarian, prostate, colon, esophageal, bladder and kidney. It said the first of these serum diagnostics should be available in early 2007.

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