NEW YORK (GenomeWeb) – NanoString Technologies today announced that the European Society for Medical Oncology has added the PAM50 gene signature to its clinical practice guidelines as a prognostic and predictive tool to determine benefit from chemotherapy.
NanoString's Prosigna Breast Cancer Gene Signature Assay is based on the PAM50 gene signature and runs on the firm's nCounter Dx Analysis System. The guidelines acknowledge the test has achieved an evidence level of 1B for its prognostic value, meaning its value has been demonstrated in individual randomized controlled trials.
"In cases of clinical uncertainty, the decision to use chemotherapy in early-stage breast cancer patients is a challenge," Miguel Martin, an ESMO member and chair of the Spanish Group for Breast Cancer Research-GEICAM, said in a statement. "Prosigna is a new and robust tool to help clinicians assess tumor biology and risk of recurrence, which may help determine the appropriateness of systemic chemotherapy."
NanoString added that ESMO guidelines indicate that the decision to use chemotherapy should be based on the intrinsic subtype, which the CE-marked version of Prosigna is certified to determine.
"This is the third European clinical practice guideline to include Prosigna, and should support our continued success in bringing breast cancer recurrence testing to patients," NanoString CEO Brad Gray said in a statement.
In March, the German Association of Gynecological Oncology acknowledged Prosigna in its breast cancer treatment guidelines.
Last month, Medicare contractor Palmetto GBA issued a favorable final local coverage determination for Prosigna, and in July the American National Comprehensive Cancer Network updated its clinical practice guidelines to acknowledge the predictive benefit of the PAM50 gene signature.