NanoString gains FDA blessing for in vitro breast cancer assay

NanoString Technologies ($NSTG) sees the U.S. launch of its new in vitro breast cancer diagnostic as a big game-changer. According to the company, it is the first prognostic gene signature assay cleared by the FDA for use in multiple qualified labs. Executives announced Sept. 9 that U.S. regulators gave the product their blessing.

"We have the hardware system and in vitro diagnostic kits that we can sell, and can be run, at any high-complexity CLIA lab," NanoString President and CEO Brad Gray told FierceDiagnostics. "We are decentralizing the type of diagnostics testing traditionally only available from special centralized labs."

The Seattle maker of life sciences tools for translational research and molecular diagnostics products said it hopes to make the Prosigna diagnostic instruments available by the 2013 fourth quarter. And the goal is for testing services to be ready to roll in the U.S. by the 2014 first quarter.

Prosigna is NanoString's first FDA-cleared in vitro diagnostic assay and represents a major milestone for that accomplishment alone. It charts the PAM50 gene signature in post-menopausal women. And as NanoString explains, it is designed to assess a patient's risk of recurrence of breast cancer through the testing of cells found in existing breast cancer tissue. The assay itself is designed for use with the company's nCounter Dx Analysis System, which can be deployed in a wide variety of labs. Gray tells us that potential customers include major cancer treatment centers, which often maintain high complexity CLIA labs, but also major centralized commercial labs such as Quest Diagnostics ($DGX) or Lab Corp.

Diagnostics companies are generally more anxious these days about obtaining insurance reimbursement for their new tests, but Gray said Prosigna should face relatively smooth sailing.

"Luckily we are launching into a marketplace that, in the U.S., is well established and well-reimbursed," Gray said. "Generally, testing for breast cancer reinsurance risk is widely reimbursed by every major health plan as well as Medicare. Prosigna will be indicated for the same patients and we expect it will be a very familiar product to payers with no incremental cost to them. They are already paying for testing."

Gray said NanoString isn't announcing product pricing yet for the U.S. But Prosigna is available in Europe, and he noted the price there amounts to about $2,000 per kit, which would be used by qualified labs to provide the service and results. By comparison, he said, rival Genomic Health's ($GHDX) Oncotype Dx test is reimbursed between $3,000 and $4,000 per patient.

Earlier this summer, NanoString celebrated a new study in the Journal of Clinical Oncology that found Prosigna identified more prognostic data than Oncotype Dx.

This is all a great stretch of good news for NanoString, which launched a scaled-back IPO earlier this summer to help commercialize Prosigna in the EU, and bring the test to the regulatory finish line in the U.S.

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