Ciphergen hires CRO for ovarian test trials
PrecisionMed to help it with upcoming clinical trials for its
experimental ovarian cancer tests.
The company has developed a panel of biomarkers that provide risk stratification information for ovarian cancer and the first task PrecisionMed will have is to assist with a prospective clinical trial for an ovarian tumour triage test called the ovarian PC1 biomarker.
Ciphergen is looking to get Food and Drug Administration (FDA) approval for the test as an in vitro diagnostic.
PrecisionMed has expertise in the collection and management of human biological samples and was selected to "assist in executing a high-quality, cost-effective clinical program," said Gail Page, president and CEO of Ciphergen.
Commonly known as the "silent killer," 14,000 people die from ovarian cancer each year in the US and 23,000 new cases are diagnosed, the majority with late stage disease and a very poor prognosis.
More diagnostic tests are urgently needed to accurately distinguish between benign and malignant pelvic masses and Ciphergen's new test is designed to allow patients with a pelvic mass to be either placed in a category of high risk of invasive ovarian cancer or a low risk.
The firm is also currently conducting studies to develop a test that can help predict recurrence of ovarian cancer as well as other ovarian tumour triage tests.
Ciphergen's diagnostic development program is being conducted in conjunction with The Johns Hopkins School of Medicine, The University of Texas M.D. Anderson Cancer Center, University College London, and the University of Kentucky, and the firm also has a partnership with Quest Diagnostics for the commercialisation of the ovarian tumor triage test, with the option to develop and commercialise two additional tests.
