Smart Stocks Watch: Atossa Genetics — FDA-Approved Diagnostic Test for Breast Cancer

Atossa Genetics [Nasdaq: ATOS] is a healthcare company focused on the development and marketing of novel cellular and molecular diagnostic risk assessment products for breast cancer through the detection of precursors to breast cancer.

Using a patented, FDA-approved Mammary Aspirate Specimen Cytology Test (MASCT) System, a nurse can painlessly collect a sample of Nipple Aspirate Fluid (NAF) in about 10 minutes. The NAF sample contains cells (cytology) and molecular diagnostic biomarkers that are useful in finding cancers and pre-cancerous changes, especially Atypical Ductal Hyperplasia (ADH), which confers a higher risk of developing breast cancer.

Tangentially, the company is developing therapies for pre-cancerous cells using patented and FDA-cleared microcatheters to deliver, directly into the milk ducts, pharmaceutical formulations that can be used to treat these pre-cancerous lesions.

According to the company, this localized delivery method allows patients to receive high local concentrations of these drugs at the site of the pre-cancerous lesions, potentially promoting efficacy of the treatment while limiting systemic exposure, which has the potential to lower the overall toxicity of these treatments.

Atossa Genetics filed for a $6MM IPO this past February. In November the company announced the pricing of the IPO worth $4 million– in which Atossa sold 800,000 shares at $5.00/share. Atossa was the sole biotech IPO filed in November. Dawson James Securities, Inc. served as the sole book-running manager for this offering.

The company now trades on the Nasdaq.

After taking a defeat in previous years, biotech has recovered this year. The Nasdaq Biotech Index has increased 30% this year, compared with 15% growth in the broader market. This year’s total number of biotech IPOs (16) matches that of 2011 with one month to go, an indication that the sector is once again stabling.

According to Burrill & Company, the diagnostics index has grown 8.2% YOY.

The global market for predictive breast cancer diagnostic and drug technologies was valued at $23.4 billion in 2010 and $21.2 billion in 2011. There are more than 40 million mammogram tests done in the US each year.

Atossa CEO Steven Quay invented the test in 2000, and has retained the patents on the technology. In 2003, the test received FDA approval.

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