“NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that Humana has issued a positive coverage decision for the Prosigna® Breast Cancer Gene Signature Assay. Humana and its more than 13 million members join other payors now covering Prosigna, collectively representing more than 175 million covered lives throughout the United States.
“This positive coverage decision is in line with updated ASCO guidelines released in February of 2016, wherein Prosigna is considered medically necessary to assess the necessity of adjuvant chemotherapy in ER-positive, HER2-negative, node-negative breast cancer patients, when adjuvant chemotherapy is not precluded due to any other factor.”
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The gist: A recent study showed that a test called Prosigna affects whether oncologists recommend chemotherapy to women with estrogen receptor (ER)-positive, node-negative breast cancer.
“NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that the results of the first Prosigna® Assay decision impact study presented at the 37th Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) showed that the use of the test significantly changed oncologists’ treatment recommendations. Conducted in collaboration with Grupo Español de Investigación del Cáncer de Mama (GEICAM), a Spanish breast cancer research group, this prospective study of the Prosigna Assay and its impact on the treatment of women with Estrogen Receptor-Positive (ER+), HER2-negative, node-negative breast cancer showed that the use of the test informed the oncologists’ recommendation whether or not to treat with adjuvant chemotherapy in addition to adjuvant endocrine therapy.
“ ‘We are very pleased to see that in this study, Prosigna was used by oncologists to make more informed decisions regarding the administration of adjuvant chemotherapy for early-stage breast cancer patients,’ stated Brad Gray, President and Chief Executive Officer of NanoString. ‘Also, we were pleased to recapitulate the results of our earlier analytical validation study, which showed that Prosigna can be run at multiple sites and generate high-quality, consistent results…’ ”
“Overall, the investigators concluded that Prosigna can be reliably performed in hospital laboratories to provide useful information beyond standard clinicopathological variables that oncologists can use to inform adjuvant treatment recommendations in clinical practice, and that this study provides additional evidence that Prosigna has analytical validity and clinical utility in real-world settings.”