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MDx/CDx Focus: NanoString Launches Prosigna in EU, Israel; Diagnovus Launches DLBCL Prognostic Test


NanoString Kicks off Global Marketing of Prosigna Gene Signature Assay

NanoString Technologies has launched its Prosigna Breast Cancer Prognostic Gene Signature Assay in the European Union and in Israel. Prosigna uses the PAM50 gene signature to gauge the tumor subtype in post-menopausal, hormone receptor-positive, early-stage breast cancer patients treated with endocrine therapy and provides a score that corresponds to an individual's risk for disease recurrence over the next decade.

According to a statement from NanoString, the company has validated the Prosigna assay in two clinical trials involving 2,400 patient samples. The test runs on NanoString's nCounter system, which is available for research use only in the US.

According to NanoString CEO Brad Gray, the EU and Israeli launch of Prosigna kicks off the company's global marketing efforts for the test.

The Prosigna assay is the first in vitro diagnostic test kit that NanoString is marketing through its commercial diagnostics business.

Diagnovus Launches Molecular Test to Gauge Recurrence Risk in Diffuse Large B-Cell Lymphoma Patients

Diagnovus has launched Engauge-cancer-DLBCL, a gene expression assay that doctors can use to risk-stratify and treat patients with diffuse large B-cell lymphoma.

DLBCL is the most common form of non-Hodgkin lymphoma and occurs in as few as seven people per 100,000 each year. Doctors use the International Prognostic Index to gauge the likelihood that a patient's DLBCL, often an aggressive tumor, will progress.

Diagnovus' DLBCL molecular test uses an algorithm to combine a patient's IPI score and the expression of two genes, LMO2 and CD137. The test operates on an RT-PCR platform and analyzes formalin-fixed paraffin-embedded tissues. The company performs the test in a CLIA-certified and CAP-accredited lab.

According to its website, Diagnovus has studied the prognostic value of Engauge-cancer-DLBCL in a 233-patient study. The company said the test was able to identify three times more patients at heightened risk of recurrence than IPI alone.

Diagnovus is hoping to market the test as a tool that can improve doctors' ability to predict DLBCL patients' outcomes compared to using IPI scores.

"Traditional stratification schemes based on clinical characteristics such as the IPI have provided prognostic guidance in the management of patients with DLBCL," Ron Levy, leader of the Lymphoma Program at Stanford University School of Medicine, said in a release from Diagnovus. "Despite the ease of use, IPI does not fully capture disease heterogeneity, and it is common to have two patients with identical IPI risk scores have very different outcomes."

DLBCL, a type of cancer that affects the B cells, occurs in older people. The standard of care is treatment with a multi-agent chemotherapy regimen combined with a CD20 antibody, called R-CHOP. Even with this treatment, DLBCL is incurable in 50 percent of people who have it, Diagnovus said.