There is a new screening for breast cancer that could have allowed Angelina Jolie to choose watchful waiting instead of a double mastectomy.
Earlier this year, Atossa Genetics launched the ForeCYTE Breast Health Test. The test uses a device similar to a manual breast pump and cytopathology to study the cells that line the milk ducts in a woman’s breasts. Most breast cancers start there.
A doctor collects fluid from each breast and sends the samples to Atossa’s CLIA-certified lab in Seattle, Washington. The National Reference Laboratory for Breast Health uses a proprietary analysis to study the fluid for precancerous cells.
The results include treatment recommendations and provide each woman with a risk number from 0 to 50 to help her understand her chances of developing breast cancer.
“Even a woman with a BRCA background begins at a risk of between 15 to 20,” Atossa founder Dr. Steven Quay said. “If we don’t find anything, she would stay at that point.”
The risk profile includes two treatment plans, depending on the woman’s risk level: lifestyle changes or chemoprevention. Quay said Atossa is working on a third option.
“We are testing the introduction of a drug in segment of the breast undergoing precancerous changes. It works very nicely and doesn’t get into the bloodstream,” he said.
Quay pointed out that breast cancer is much more common than cervical cancer, but there is no treatment or screening similar to the pap smear for tracking the health of breast cells.
“We hope our test can be used to find the 10 million women who may develop breast cancer and push the reset button,” Quay said.
Quay founded the company in 2009. He holds 75 patents, including several for ultrasound and Magnetic Resonance Imaging (MRI) contrast agents such as Omniscan, Teslascan, and Optison (Perflutren), which is marketed by GE Healthcare. Quay is an anatomic pathologist and is a former faculty member of the pathology department at Stanford University School of Medicine. He founded SONUS Pharmaceuticals. This is his sixth startup.
Atossa also considers family history and personal reproductive history to calculate a woman’s lifetime risk of developing breast cancer. The goal is to make this test part of the annual OBGYN visit and as common as a pap smear. Both the collection and the testing are covered by Medicare and private insurance.
Atossa believes that specific biomarker patterns will be found for each stage of breast cancer–from normal growth to hyperplasia to atypical ductal hyperplasia to carcinoma in situ to invasive cancer.
With most breast cancers, cell division takes one to two months. By the time a woman or her doctor can feel the lump, the cancer has been growing for two to five years. Mammograms can usually detect lumps at one-quarter inch in size or smaller.
The ForeCYTE test has the potential to track cellular changes over several years and detect precancerous cells and cancer cells very early on, Quay said.
The ForeCYTE test was launched nationally in January. Fewer than 5,000 tests have been done. The device was cleared by the U.S. Food and Drug Administration.
Atossa had its IPO in November 2012 and sold 800,000 shares at $5 each. The company raised $4 million, the minimum needed to get on Nasdaq’s small-capitalization market tier.
An analyst on Seeking Alpha called Atossa a top biotech idea for 2013.
This test has been recalled in Nov, 2013. FDA also accuses the company of not have any FDA clearance for the Forecyte test before they started to market this device and test. Can you comment on this?
Every woman should get this test! I was fortunate enough to be able to choose this at my annual exam a few weeks ago, and although my mammogram came back with no positive results, the ForeCYTE was able to spot pre-cancerous cells in one of my breasts. I was able to speak with my doctor and find ways to become proactive in my health to help lower my risk factor. I'm so thankful that this test came along for me before it was too late.