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NCI Wants Cancer MDx Validation Studies

NEW YORK (GenomeWeb News) – The National Cancer Institute wants to fund investigators to conduct clinical validation studies of new molecular diagnostics for determining prognosis or predicting response to cancer therapies.

Under two new funding announcements, NCI said this week that it seeks to support research to evaluate the clinical utility of analytically validated molecular diagnostic tests that can be used to improve clinical decision-making in the care and treatment of cancer patients. The institute specifically wants studies that use specimens from multi-site cancer trials.

To support the program, NCI will fund research project (R01) grants for up to five years and exploratory/development (R21) grants with up to $275,000 for two years.

Investigators receiving funding should use it to develop assays that will be suitable for validating clinical markers in trials and providing evidence that using the marker improves clinical outcomes.

Specifically, NCI wants to fund research to validate diagnostics for: selecting patients with outcomes without consideration for treatment; predicting drug sensitivity for rational trial designs that stratify patients for specific anti-cancer treatments; predicting resistance to determine alternative therapies following cancer recurrence; predicting toxicity; providing rationale for administering lower doses of a specific therapeutic agent; determining therapeutics for rational combination therapies to boost anti-tumor response; mining of molecular profiles for novel prognostic and predictive markers; finding new targets for therapy.

Although there is a large body of literature on diagnostic and prognostic factors in cancer patients, the rate of acceptance of new markers for use in making treatment decisions has lagged, and few such markers or assays are being used in the clinic, NCI said.

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