New test finds early indicators of breast cancer

A Seattle company has developed a test to detect early signs of breast cancer that could save billions of dollars in unnecessary biopsies and surgeries.

The best diagnostic test available is the mammogram, but it’s notorious for producing false positives.

“There are 1.3 million biopsies every year of things that are seen on mammography. Only 15 percent are cancer, the rest are benign conditions,” said Dr. Steven Quay, chairman and President of Atossa Genetics.

“We spend billions of dollars cutting open breasts or putting needles into breasts because of things we see on mammography that are not cancer,” said Quay.

Quay’s company has designed a test, called ForeCYTE. That does what a mammogram cannot: detect breast cancer before it happens. The pre-cancerous condition is called hyperplasia.

“What our test does in a 10-minute process in the office is to collect a tiny amount of fluid from each breast through the nipple. It’s not painful; it uses a modified breast pump and then we look under the microscope for that very cancer-causing process: hyperplasia,” explained Quay.

Mammograms are typically recommended for women at age 50. Because cancer develops over 10 to 15 years, Dr. Quay said this new test is designed for younger women.

“The math is that women in their 20s, 30s, and 40s are having this silent condition that we now can detect with a simple process.”

The two-step process involves an office visit with a nurse to collect samples and laboratory analysis; both would be billed to health insurance providers. The device used to collect the fluid from the breast has been approved by the FDA, but it’s not widely available. Dr. Quay thinks it should be in every OB-GYN office.

“Seventy percent of women who get breast cancer have no risk factors,” according to Dr. Quay. “So saying, ‘Well, it’s not in my family, I don’t have to worry about it,’ is not a good idea. Eight out of nine women who get breast cancer have no family history.”

The ForeCYTE test is based on the same concept as the Pap smear, used to detect cervical cancer.

“Cervical cancer has been reduced by 70 percent compared to 1950 before the Pap smear was introduced,” said Dr. Quay. “It’s the most successful screening test in all of medicine and we think we can do the same thing for the breast.”

Atossa Genetics calls itself the Breast Health Company and it’s on to its next challenge. Clinical trials have been conducted on a treatment for women diagnosed with a pre-cancerous condition, delivering targeted, high doses of cancer-fighting drugs to the breast, as much as 40 times more medicine than using traditional methods, killing the cancer cells with almost zero side effect.

Once that breast cancer treatment option is approved, Dr. Quay thinks the ForeCYTE breast cancer test will become a routine screening.