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NanoString Focused on Growing Prosigna Adoption, Reimbursement


With new publications and an expanding sales force, NanoString is ramping up its efforts to bolster adoption of its Prosigna breast cancer recurrence test.

During its year-end earnings call last week, NanoString CEO Brad Gray provided an update to Wall Street analysts and investors regarding the company's strategy for increasing use and reimbursement for Prosigna ─ a test that uses the PAM-50 gene signature to assess a woman's risk of breast cancer recurrence 10 years after diagnoses of early-stage disease.

The company gained 510(k) clearance from the US Food and Drug Administration for Prosigna in September. NanoString also completed a financing round, in which it raised $57 million that it will put toward funding its growth strategies for Prosigna and its nCounter brand of instrument platforms. In 2013, Prosigna brought in $181,000 in revenues, while instrument sales grew 48 percent year over year to $13 million.

After gaining FDA's nod, NanoString installed in the fourth quarter six nCounter systems designed to run the Prosigna test at Premier National Diagnostic Labs, ARUP, Laboratory Corporation of America, Quest, and several cancer centers. "We expect the US labs [that] have adopted Prosigna to begin offering custom services over the course of the first half of 2014," Gray said during the webcast call last week.

LabCorp announced its launch of Prosigna testing in January, and Gray said that ARUP and Quest are planning to do the same by end of this month. "Discussions are underway with other cancer centers and commercial labs," he added.

NanoString is also building a sales force to spread the word about Prosigna among doctors and labs. The company is in the process of hiring a team of 15 oncology sales reps and expects to have them fully trained by the end of the current quarter.

Recognizing that reimbursement is also a critical factor in growing adoption of the test, NanoString has begun forming a team that will lead efforts in this regard. These reimbursement experts will be in charge of establishing reimbursement codes for Prosigna and pursuing coverage under the MolDx program. Launched by the Centers for Medicare & Medicaid Services, MolDx is a program designed to evaluate the evidence underlying molecular tests and set payment rates based on certain criteria, such as if the test was approved by the FDA and has studies establishing its clinical validity and utility.

Gray said that during the fourth quarter NanoString applied for a so-called multianalyte assays with algorithmic analysis (MAAA) code from the American Medical Association and a unique identifier, called a Z-Code, from McKesson. "Earlier this month we were assigned our Z-Code, and we expect to learn in the weeks ahead whether we will be assigned a unique MAAA CPT code," Gray said.

The company has also begun discussions with officials from Palmetto, the Medicare contractor running CMS's MolDx program. "We continue to be optimistic that we could receive a positive coverage decision by as early as Q3 2014 for the states covered by Palmetto and [Medicare contractor] Noridian, which include North Carolina and California, home to the largest molecular diagnostic testing sites for LabCorp and Quest respectively," Gray said. He characterized the achievement of Medicare reimbursement "as a major catalyst for Prosigna uptake," and noted that the company's 2014 revenues would be "highly sensitive" to the timing of test reimbursement.

One of the most effective drivers of test adoption, as shown by the experience of Genomic Health, is for bodies that issue guidelines to recommend the use of the diagnostic in patient care. Nearly all major breast cancer guidelines, including recommendations from the National Comprehensive Cancer Network, support the use of Genomic Health's Oncotype DX breast cancer recurrence test, the current leader in this diagnostics market.

NanoString is also hoping for inclusion in NCCN guidelines. "We are confident that we will submit to NCCN a strong case for consideration of inclusion for Prosigna in their guidelines," Gray said.

Toward this end, NanoString has been rapidly publishing data to lay out the clinical validity and utility for Prosigna as both a prognostic and predictive breast cancer diagnostic. Genomic Health's Oncotype DX is currently the only molecular diagnostic that is indicated as being able to gauge recurrence of breast cancer and predict whether patients will respond to chemotherapy.

Genomic Health performs Oncotype DX in a CLIA-certified lab; the test does not have FDA clearance or approval. The agency-cleared Prosigna label indicates it as a test to gauge distant breast cancer recurrence.

By the first half of 2014, NanoString is aiming to have six peer-reviewed publications for Prosigna. The company is half way toward meeting that goal.

In December, NanoString published the pivotal validation study for Prosigna in the Annals of Oncology, showing that patients deemed to be at low risk of recurrence are unlikely to benefit from chemotherapy. The authors of this paper concluded that the test had "level 1" evidence required for inclusion in treatment guidelines.

Also in December, researchers published a paper in Acta Oncologica on Prosigna's ability to predict which patients with locally advanced or metastatic breast cancer will benefit from the chemotherapeutic gemcitabine. Then, researchers published data in February in Clinical Cancer Research showing that Prosigna was better than clinical factors alone in gauging late recurrence of breast cancer.

Gray added that a fourth paper, "describing the multi-site analytical validation of Prosigna," has been accepted for publication. These studies add to the growing body of knowledge on Prosigna. Earlier in 2013, NanoString had published papers comparing Prosigna to Oncotype DX based on retrospective analysis of samples from the TransATAC study.

Beyond driving adoption of Prosigna in the US, NanoString also has its sights on Europe, where the company is "laying the foundation" for future test adoption, Gray said. "Our top priority has been to place Prosigna-capable nCounter Systems in major academic centers and then work with the leaders in these centers to advocate for reimbursement."

The company is conducting a decision impact study for Prosigna in Spain and has enrolled 200 patients in the trial. NanoString hopes to present data from this study later in the year. The company is also enrolling patients in a decision impact study in Germany, and it intends to initiate a third decision impact study in the EU later this year, according to Gray.