After officially launching its ForeCYTE Breast Health Test earlier this year, Atossa Genetics is working to drive adoption of the test as a tool to screen women for precancerous changes in their breast cells that place them at heightened risk for cancer.
Earlier this month, Seattle, Wash.-based Atossa announced that the medical device distributor Millennium HealthCare will make available the ForeCYTE test and the patented MASCT pump, which draws out the necessary nipple aspirate fluid the test analyzes, to managed care networks, healthcare clinics, and physicians' practices across the New York metro area and northern New Jersey.
Millennium has submitted an initial order for 10,000 ForeCYTE collection kits under this distribution deal. Atossa believes ForeCYTE can be an important breast cancer screening tool for 110 million US women between ages 18 and 73, claiming that its test can pick up on a woman's risk of breast cancer eight years before mammography can.
Breast cancer most often begins in the cells that line the ducts, which is why Atossa believes that by analyzing the changes in these types of cells from NAF, ForeCYTE can detect malignant changes that can lead to cancer before the disease progresses. After the MASCT pump takes an NAF sample, the ForeCYTE test analyzes it for cytological changes and abnormalities in five molecular biomarkers: low molecular weight cytokeratins CK7 and CK18 in luminal cells; high molecular weight CK5 and CK14 in basal cells; and nuclear antigen p53 in myoepithelial cells.
The test uses an algorithm to determine whether these cells are normal, hyperplastic, or atypical hyperplastic based on their cytological and molecular characteristics. Factoring in the woman's family history of breast cancer and her personal reproductive history with these detected changes, the test then determines a woman's 10-year risk of breast cancer and her lifetime risk of the disease.
ForeCYTE can analyze NAF samples as small as 7 picoliters. The MASCT system, which is used to collect the NAF sample, is not invasive and "delivers a painless suction" to draw out the fluid, Atossa highlights in a brochure for the test.
Atossa CEO Steven Quay told PGx Reporter that the company believes that physicians should begin screening young women with ForeCYTE at around age 20, about the same time they get their first pap smear. Although the risk of breast cancer in younger women is very low for women in their 20s – with less than 7 percent of all breast cancers occurring in those under 40 years old – the disease is also harder to detect due to denser breast tissue.
"Two weeks ago I had two women, 24 years and 27 years old, one with a family history [of cancer] but the other without," Quay said. "Both of them actually had atypical hyperplasia."
According to the company, if ForeCYTE detects atypical hyperplastic cells in a woman, she has a 15 percent risk of being diagnosed with breast cancer in the next two years. "To put things into perspective, that's the same [lifetime] risk as a normal woman just walking down the street," Quay said. Comparatively, a woman who is deemed to have a "normal" risk of breast cancer by the ForeCYTE test has a 0.3 percent chance of being diagnosed with breast cancer within a two-year period, according to Atossa.
The company believes that ForeCYTE will offer critical insights about a younger woman's breast cancer, particularly if they don't qualify for mammography screening. The US Preventative Services Task Force recommends in its mammogram guidelines screening women every two years starting at age 50. For older women who qualify for mammograms, the ForeCYTE test can be used as an adjunct tool to garner additional insights about their breast cancer risk.
In the test brochure, the company recommends annual screening with ForeCYTE for all women between the ages 18 to 73 and bi-annual screenings for women over 35 who are deemed to have an intermediate life-time risk of breast cancer according to the test.
Quay said that the company will conduct clinical utility studies to sway payors to cover the ForeCYTE. Currently, it has a financial assistance program to help pay for the test for those that qualify.
"But the bar" to establish clinical utility "is set very high for screening tests," Quay acknowledged. "Both the pap smear and the mammogram became screening tests after the US government … did longitudinal studies of five years or greater in more than 100,000 women in each case."
ForeCYTE is currently reimbursed by Medicare at around $500, according to Quay. In 2011, the US Food and Drug Administration cleared ForeCYTE as a test that analyzes NAF to determine or differentiate between normal, premalignant, and malignant cells. Last year, Atossa garnered CLIA certification for its National Reference Laboratory for Breast Health, where it performs the ForeCYTE tests.
The company also has its own sales force that will market the test to Ob/Gyns and primary care physicians. "We think this test will be adopted," Quay said. "It's very popular when we speak about it to women's groups." In January, when Atossa announced the official commercial launch for ForeCYTE, Boca Raton, Fla.-based diagnostics distribution firm Clarity Women's Health said it would market the test.
In announcing its first-quarter financial results earlier this month, Atossa attributed the growth in revenues to the nationwide launch of ForeCYTE. In the first quarter, Atossa reported revenues of $182,670, compared to $54,713 in the year-ago quarter. Revenues from diagnostic testing services were up 221 percent during the quarter, from $52,713 a year ago to $169,230. Product sales grew from $2,000 in the first quarter of 2012 to $13,440 this year, a six-fold increase attributable to sales of the MASCT system.
The company's net loss during the first quarter crept up, from $1.1 million a year ago to $1.9 million this year. Meanwhile, R&D costs decreased by 47 percent, from $417,990 in the first quarter of 2012 to $220,192 in the latest quarter. Due to the launch of ForeCYTE and expenses related to hiring additional staff, Atossa reported a 169 percent increase in SG&A spending to $1.8 million from the previous year's $671,887.
The company finished the quarter with $1.4 million in cash and cash equivalents.
In addition to ForeCYTE, the company has also introduced to a limited customer base its ArgusCYTE test, which gauges circulating breast tumor cells and molecular markers to help physicians gauge breast cancer progression and determine treatment strategies. Atossa will officially launch this test later this year.