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NUVERA PIPELINE

Nuvera has several collaborations with academic and industrial groups in cancer genomics, clinical bioinformatics, and advanced molecular analyses to develop predictive tests for a range of cancer therapies. Nuvera continues to explore R&D alliances to develop and commercialize a broad diagnostic test portfolio for drug response and drug resistance.

Aromatase Inhibitors

Breast cancer patients who are estrogen-receptor positive are increasingly given aromatase inhibitor (AI) therapy as an alternative to tamoxifen, especially if the patients are at post-menopausal stage. Although oncologists believe AIs offer some benefit over tamoxifen, it is unclear currently, and no test is available to predict who needs aromatase inhibitor therapy versus standard tamoxifen. Nuvera is developing biomarkers with an ability to identify early response in patients who receive AI therapy. The assay is being further developed with multiple cohorts of patients who received only aromatase inhibitor therapy versus standard tamoxifen.

Anthracycline-based chemotherapy

Chemotherapy based on anthracyclines without taxanes continues to be used worldwide, with a greater prevalence of usage in Europe and Asia. Within breast cancer chemotherapy, no test currently identifies which patients could benefit from anthracyclines and who would need addition of taxanes to the regimen. Nuvera is currently developing a gene signature using prospective clinical studies of patients who received standard non-taxane anthracycline therapy. This assay would be a complement to the taxane-specific test developed by Nuvera.

Resistance to standard therapy

More than 1/3rd of all breast cancer patients are resistant to any standard therapy. Identifying these patients today is not possible with available tests which results in wasteful time and expense of therapy. These patients, if identified early, can be candidates for clinical studies of combinations with new targeted therapies. Nuvera is developing biomarkers for therapy-resistance and evaluating its performance on breast cancer patients receiving several standard chemotherapy regimens. Patients identified to be resistant are also being studied for response to targeted therapies.

Other cancer therapies

Several other cancers have multiple approved therapy regimens available and offer the same opportunity for therapy stratification decisions using predictive tests. Nuvera is currently working with collaborators to characterize and validate biomarkers predictive of response and resistance to taxanes in other cancers.

Nuvera is also developing response-associated measures for receptor-targeted therapies. Since targeted therapies are developed to act on a single receptor, a measure of the pathway activity associated with that specific receptor can be an excellent indicator of true responders. Nuvera is studying receptors and their related therapies, either approved for use or in clinical development, in cancers such as colon, lung and esophageal.

21st Century Diagnostics