Atossa teams with Thermo to market 'Pap smear for breast cancer'

Atossa is partnering with Thermo Fisher to expand its ForeCYTE breast health diagnostic.--Courtesy of Atossa

Atossa Genetics ($ATOS) has been steadily expanding the reach of its ForeCYTE breast health test, and now the company has inked a distribution deal with Thermo Fisher ($TMO), seeking a brighter spotlight for a diagnostic Atossa says could change the lives of millions.

Under the agreement, Thermo will distribute Atossa's hand-held MASCT testing device through its Fisher Healthcare segment, with Atossa processing ForeCYTE test results through its CLIA-certified lab in Seattle.

The device non-invasively collects small amounts of patients' nipple aspirate fluid for cytological analysis, providing early detection of cancer or pre-cancerous conditions commonly missed in mammography, all through a 10-minute in-office procedure. That information can guide preventative treatment that could save lives and drag down rates of breast cancer, Atossa CEO Steven Quay said, much like the Pap smear has revolutionized cervical cancer diagnostics since its introduction.

"Our test does exactly the same thing," Quay said in an interview with FierceMedicalDevices. "Our real goal is the long-range treatment of benign proliferative breast disease to actually prevent breast cancer. So, just like the Pap smear led to a 70% reduction in cervical cancer rates, we have the same program with the breast."

Atossa CEO Steve Quay

Atossa launched ForeCYTE in January, building its sales staff and marketing the test largely to individual OB/GYNs and regional medical groups. Now, the Fisher partnership sets the stage for a much wider adoption for the test, as the company's network includes hospitals, large clinics and group purchasing organizations.

Judging by the early response from patients and physicians, ForeCYTE has an excellent chance at becoming the standard of care in breast health testing, Quay said. Atossa's target patient population is about 110 million in the U.S. alone, including women with complicating factors like dense breasts, breast implants and BRCA gene mutations.

Next, the company plans to launch two new MASCT-powered tests: FullCYTE, which can detect which of a breast's ducts is undergoing pre-cancerous or cancerous changes, and NextCYTE, a genomics-based diagnostic to help direct treatment of early-stage breast cancer. Atossa plans to get those on the market this year and promote all its offerings as a battery of tests branded CarePath, Quay said.

- read Atossa's statement

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