SOURCE: Atossa Genetics, Inc.

Atossa Genetics, Inc.

May 03, 2011 08:30 ET

Atossa Genetics, Inc. and HLB, LLC Announce Partnership to Manufacture Atossa's Patented, FDA-Cleared MASCT System for Breast Cancer Risk Assessment

SEATTLE, WA and CHICAGO, IL--(Marketwire - May 3, 2011) - Atossa Genetics, Inc., a privately-held health care company focused on the development and marketing of novel cellular and molecular diagnostic risk assessment products and services for breast cancer, announced today a partnership agreement for the manufacture of Atossa's patented, FDA-cleared Mammary Aspirate Specimen Cytology Test (MASCT) System for field testing prior to full commercial launch.

The MASCT System, which was designed by HLB and has received FDA-clearance, is a medical device and method for the collection, shipment and clinical analysis of nipple aspirate fluid, or NAF. The clinical analysis of NAF, which contains cells and molecular diagnostic biomarkers, is useful in detecting breast cancer and cellular changes that may be precursors to breast cancer. The product component of the MASCT System consists of a reusable hand-held pump device for the collection of NAF, a patient kit that includes two NAF sample vials, and a shipment kit for the transportation of NAF samples to a specialized cytology and molecular diagnostics laboratory.

"We are pleased to be working with HLB on the manufacturing of sufficient MASCT System devices and kits for field testing as a final step before commercial launch," stated Steven C. Quay, M.D., Ph.D., Chairman and Chief Executive Officer of Atossa Genetics. "HLB is widely recognized as a leading medical device and consumer product design company that has received more than a dozen awards for medical products over the years."

"HLB is proud to be working again with Atossa on the MASCT System, another medical product created by the Meaningful Design™ system that is unique to HLB," stated Ford Pearson, President, HLB, LLC. "We are hopeful that the use of the MASCT System as an adjunct to mammography will provide a critical new assessment tool for identifying women at high risk for breast cancer."

About the Mammary Aspirate Specimen Cytology Test System
The MASCT System, a "Pap test for breast cancer," is designed to collect nipple aspirate fluid (NAF), which contains cells from the lining of the milk ducts and the lobules where approximately 85% of all breast cancers originate. Once collected, the NAF sample will undergo analysis in Atossa's specially equipped pathology lab to determine whether the cells are normal, atypical (premalignant), or malignant. The MASCT System uses no radiation, is simple, painless, and inexpensive, and takes less than 5 minutes in a doctor's office or mammography center. The MASCT System is intended as an adjunct to mammography for women ages 40 to 75 and for younger women at high risk for breast cancer.

The MASCT System is expected to be launched in the Pacific Northwest this year and across the U.S. in 2012.

About Atossa Genetics, Inc.

Atossa Genetics, Inc. is a privately held health care company dedicated to improving breast health by commercializing the Mammary Aspirate Specimen Cytology Test System (MASCT System) and second-generation products in development. Patients, health care providers, investors and others seeking information on the MASCT System or the latest information and research on breast cancer risk assessment, diagnostics, prevention, and treatment options, should visit www.atossagenetics.com.

Contact Information

  • Contacts:
    Steven C. Quay, M.D., Ph.D. (Corporate)
    Chairman, President and CEO
    206-325-6086
    Email Contact

    Matthew D. Haines (Investors and Media)
    Managing Director
    MBS Value Partners
    212-710-9686
    Email Contact