8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 9, 2013

NanoString Technologies, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-35980	20-0094687
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

530 Fairview Avenue North, Suite 2000

Seattle, Washington 98109

(Address of principal executive offices, including zip code)

(206) 378-6266

(Registrant’s telephone number, including area code)

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01 Other Events.

On September 9, 2013, NanoString Technologies, Inc. (the “Company”) issued a press release announcing that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay (“Prosigna”), which provides a patient’s risk of distant recurrence of breast cancer.

Prosigna is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years in patients who are treated with adjuvant endocrine therapy when used in conjunction with other clinicopathological factors. Prosigna is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. The indicated patients are post-menopausal women with hormone receptor-positive breast cancer that is either Stage I or II lymph node-negative, or Stage II lymph node-positive with one to three positive nodes. Prosigna is not intended for patients with four or more positive nodes, or for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients.

In the United States, Prosigna’s test output will be a patient-specific report that includes both a risk category and an integer risk score, called the Prosigna score, ranging from zero to 100. The Prosigna score relates to an individual patient’s probability of distant recurrence within 10 years and is identical to the risk of recurrence (ROR) score referred to in scientific publications and in the Company’s CE-marked version of Prosigna. Patients with lymph node-negative disease are categorized into one of three risk groups (low, intermediate or high). Patients with one to three positive lymph nodes are categorized into one of two risk groups (low or high). Node-positive breast cancer patients with Prosigna scores of greater than 80 are automatically considered “high risk” and their specific scores are reported as “greater than 80.” The report notes that results apply to patients treated for five years with endocrine therapy as in the patient population tested in the clinical validation study.

Laboratories administering the Prosigna assay will require the Company’s nCounter Dx Analysis System, related software and the Prosigna assay kits. The Company’s nCounter Dx Analysis System can run up to 10 patient samples in a single run and complete three runs (or 30 patient samples) in an eight hour workday. Assuming a single nCounter Dx Analysis System runs five days per week, approximately 7,500 Prosigna assays can be processed per year. The Company estimates that in 2012 between 65,000 and 75,000 genomic breast cancer assays were run in the United States.

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for shipment to initial U.S. clinical laboratory customers late in the fourth quarter of 2013 and Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014. To support the commercial launch, the Company is taking multiple steps, including working to incorporate final input from the FDA into the Prosigna software and labeling, building an inventory of nCounter Dx Analysis Systems and the 510(k)-cleared Prosigna kits, preparing materials to support reimbursement of Prosigna and recruiting additional personnel to support the commercial launch.

This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are identified by such words as “believe,” “expect,” “anticipate,” “estimate,” “plan,” “may” and words of similar import and are based on current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. All statements other than historical or current facts, including, without limitation, statements about our plans for the U.S. commercial launch of Prosigna, the potential throughput of nCounter Dx Analysis Systems running the Prosigna assay and the estimated number of breast cancer assays run in the United States. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. These statements, like all statements in this report, speak only as of their date.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number	Description
99.1	Press release dated September 9, 2013.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

NanoString Technologies, Inc.
By:	/s/ R. Bradley Gray
	R. Bradley Gray
	President and Chief Executive Officer

Date: September 9, 2013

EXHIBIT INDEX

Exhibit Number	Description
99.1	Press release dated September 9, 2013.

EX-99.1

Exhibit 99.1

NanoString Technologies Receives FDA 510(k) Clearance for Prosigna™

Breast Cancer Prognostic Gene Signature Assay

Prosigna Assay on the nCounter^® Dx Analysis System Provides Compelling Clinical Data,

Clear Patient Report, and Decentralized Testing in Qualified Labs

SEATTLE — September 9, 2013 — NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Prosigna™ Breast Cancer Prognostic Gene Signature Assay. Based on the PAM50 gene signature, Prosigna is the company’s first FDA-cleared in vitro diagnostic assay and uses the gene expression profile of cells found in breast cancer tissue to assess a patient’s risk of distant recurrence of disease. The Prosigna Assay is performed using the nCounter^® Dx Analysis System, which can be placed in qualified laboratories throughout the United States, empowering oncologists and pathologists to quickly and easily meet the testing needs of their breast cancer patients.

“Receipt of FDA 510(k) clearance for Prosigna marks a key milestone for NanoString and is an important step forward in the treatment of breast cancer. This achievement is a testament to the ongoing dedication and professionalism of our team, and the commitment of our collaborators,” said Brad Gray, President and Chief Executive Officer of NanoString Technologies. “Prosigna illustrates our approach of using nCounter technology to translate genomic discoveries into powerful in vitro diagnostic products, and it represents a significant growth opportunity beyond our robust life sciences research business.”

The Prosigna Assay is intended for use as a prognostic indicator for distant recurrence-free survival at 10 years, and is indicated for postmenopausal women with Stage I/II lymph node-negative or Stage II lymph node-positive (one to three positive nodes) hormone receptor-positive breast cancer who have undergone surgery in conjunction with locoregional treatment consistent with standard of care. For each patient, the Prosigna Assay reports the Prosigna Score (referred to as Risk of Recurrence Score, or ROR Score, in the scientific literature, including the TransATAC study recently published in the Journal of Clinical Oncology¹) and a risk category based on both the Prosigna Score and nodal status. Node-negative patients are classified as low, intermediate or high risk, while node-positive patients are classified as low or high risk.

Other key features of the Prosigna Breast Cancer Prognostic Gene Signature Assay include:

• All-in-one assay consumables, including RNA extraction kits, allowing laboratories to test as little as a single section of formalin-fixed paraffin embedded (FFPE) tumor tissue

• High-throughput workflow allowing each nCounter Dx Analysis System to process up to 30 patient samples per eight hour work day

¹  Dowsett M. et al. on behalf of the ATAC and LATTE Trialists Group. Comparison of PAM50 Risk of Recurrence Score With Oncotype DX and IHC4 for Predicting Risk of Distant Recurrence After Endocrine Therapy. Journal of Clinical Oncology. ePub ahead of print July 1, 2013 as 10.1200/JCO.2012.46.1558

• Automated generation of personalized full-color patient reports that can be quickly and easily shared electronically with ordering oncologists

Bruce Seeley, Senior Vice President & General Manager of Diagnostics of NanoString Technologies commented: “We believe that the compelling clinical data, clear patient reporting, and unique delivery model position Prosigna for success in the U.S. market. By integrating the Prosigna Assay into existing laboratory workflows, we are offering physicians and patients seamless and timely access to clinical insights and a powerful tool that can aid in making more informed treatment decisions.”

Prosigna-enabled nCounter Dx Analysis Systems are expected to be available for placement in high-complexity Clinical Laboratory Improvement Amendments (CLIA) certified laboratories late in the fourth quarter of 2013. Prosigna testing services are expected to be available through qualified U.S. clinical laboratories beginning in the first quarter of 2014.

Conference Call

NanoString management will host an investment community conference call on Tuesday September 10 beginning at 5:30am PT / 8:30am ET to discuss these developments. Individuals interested in listening to the conference call may do so by dialing (888) 793-9492 for domestic callers, or (734) 385-2643 for international callers, or from the webcast on the investor relations section of the company’s website at: www.nanostring.com. The webcast will be available on the company’s website for 14 days following the completion of the call.

About the Prosigna™ Breast Cancer Prognostic Gene Signature Assay

Prosigna provides a risk category and numerical score for assessment of the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative (Stage I or II) or node-positive (Stage II), hormone receptor-positive (HR+) breast cancer. Based on the PAM50 gene signature initially discovered by Charles Perou, Ph.D. and colleagues, the Prosigna Assay is an in vitro diagnostic tool that utilizes gene expression data weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence. The Prosigna Assay measures gene expression levels of RNA extracted from formalin-fixed paraffin-embedded (FFPE) breast tumor tissue.

The Prosigna Assay requires minimal hands-on time and runs on NanoString’s proprietary nCounter Dx Analysis System, which offers a reproducible and cost-effective way to profile many genes simultaneously with high sensitivity and precision.

The Prosigna Assay will be available for diagnostic use when ordered by a physician in the U.S. The Prosigna Assay has been CE-marked and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark and in which Prosigna is registered.

Prosigna is not intended for diagnosis, to predict or detect response to therapy, or to help select the optimal therapy for patients in the U.S.

For more information, please visit www.prosigna.com.

About NanoString Technologies, Inc.

NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company’s nCounter^® Analysis System, which has been employed in basic and translational research since it was first introduced in 2008 and cited in more than 240 peer-reviewed publications, has also now been applied to diagnostic use as the nCounter Dx Analysis System. The company’s technology offers a cost-effective way to easily profile the expression of hundreds of genes, miRNAs, or copy

number variations, simultaneously with high sensitivity and precision. The company’s technology enables a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The nCounter-based Prosigna™ Breast Cancer Prognostic Gene Signature Assay is the first in vitro diagnostic assay to be marketed through the company’s diagnostics business.

For more information, please visit www.nanostring.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the growth opportunity Prosigna represents, the potential throughput of nCounter Dx Analysis Systems running the Prosigna Assay, the timing of the U.S. commercial launch of Prosigna and the impact of the Prosigna launch on the company’s business. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with keeping pace with rapidly changing technology and customer requirements; risks regarding our ability to successfully introduce new products; risks that new market opportunities may not develop as quickly as expected; risks associated with competition in marketing and selling products; risks of increased regulatory requirements; as well as the other risks set forth in the company’s filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.

The NanoString Technologies logo, NanoString, NanoString Technologies, and nCounter are registered trademarks, and Prosigna is a trademark of NanoString Technologies, Inc.

Investor Contact:

Lynn Pieper of Westwicke Partners

Email: lynn.pieper@westwicke.com

Phone: 415-202-5678

Media Contact:

Maurissa Messier of Bioscribe Inc.

Email: Maurissa@bioscribe.com

Phone: 760-539-7417