NanoString Starts Selling First Breast Cancer Test in EU

NanoString Starts Selling First Breast Cancer Test in EU

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NanoString is seeking to sell its nCounter instrument—currently priced at 205,100 Euros—to European pathology labs who don’t already have one. For those who spend the money upfront for the instrument, the chemical reagent kit to perform each breast cancer test will be 1,550 euros, Gray says. Those who choose to rent an nCounter instrument will pay a slight premium for each reagent kit, but the amount will depend on volume commitments, Gray says.

Although exchange rates will vary over time, it’s clear that NanoString is giving its customers an incentive to buy the machine and use it a lot. The more they use the instrument, the cheaper each patient’s test will be when you factor in the cost of the instrument on top of the 1,550 euro reagent kit. The overall size of the market is anybody’s guess at this point, but Gray notes that market research by Globocan says there were 1.4 million cases of breast cancer diagnosed worldwide in 2008, and one-fourth to one-fifth were in Europe, when including part of Russia.

Like with any new product rollout, much work needs to be done. The company has hired European sales people, whose job will be to explain the value of the Prosigna test, as described in a pair of clinical trials that looked at 2,400 patient samples. The other big task is securing reimbursement from health authorities in each of the EU member countries. NanoString plans to focus initially on big EU countries like Germany, France, Spain, and Italy, Gray says.

Gray didn’t have much to say about the reimbursement picture just yet.

“It’s very early days,” he says. “Unlike in the U.S., where this category of medical care has been widely reimbursed, outside the U.S., reimbursement is very spotty. We are just beginning engagement with government payers.”

Gray, a Genzyme veteran who joined the company as CEO in June 2010, picked up a license to the PAM50 intellectual property six months later, and then spent the next two years gathering data it needed from clinical trials to make it into a diagnostic test. The company isn’t yet ready to start selling the product in the U.S., where it plans to seek FDA approval first. It got clearance from European regulators in late September, and pledged then to start selling the breast cancer product in the EU by early 2013.

“It’s been a rush, a lot to achieve in a short period of time,” Gray says. “We basically built the diagnostic capabilities from scratch. It will be tremendously rewarding to see the first wave of breast cancer patients being helped by our product.”

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