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Weill Cornell Medicine researchers received a $2.4 million grant from the U.S. Department of Defense Breast Cancer Research Program to validate a new blood test for the early detection of breast cancer.

Researchers are evaluating Syantra DX Breast Cancer (Syantra Inc.), an experimental diagnostic test that detects specific biomarkers in blood associated with breast cancer. The test uses an artificial intelligence algorithm to determine whether a patient is positive for cancer as soon as detectable by mammogram or possibly earlier, and before symptoms arise.

“This new liquid biopsy, or blood test, has the potential to detect breast cancer at a very early stage. Early diagnosis means treatment can start sooner when it is most effective, saving lives,” said the study’s principal investigator Dr. Massimo Cristofanilli, professor of medicine and director of breast medical oncology in the division of hematology and medical oncology at Weill Cornell Medicine.

Each year, about 240,000 women are diagnosed with breast cancer and nearly 42,000 die from the disease, according to the Centers for Disease Control and Prevention. “Because of modern treatment methods, 86 percent of women diagnosed with stage 3 breast cancer survive past five years. However, this number drops to just 28 percent in women diagnosed at stage 4,” said Dr. Cristofanilli, who is also a medical oncologist at NewYork-Presbyterian/Weill Cornell Medical Center.

Finding cancer early can also reduce the need for invasive treatments like double mastectomy and chemotherapy, which can cause nausea, vomiting and hair loss, and other difficult side effects.

Diagnosing Women with Elevated Breast Cancer Risk

Previous smaller studies showed promise in women who were at a lower risk of breast cancer. With this grant, Dr. Cristofanilli will evaluate the performance of the Syantra DX Breast Cancer test in women ages 30 to 75 who have an elevated risk of developing breast cancer, including those with dense breast tissue, abnormal mammograms, genetic predisposition, or suspicious breast symptoms.

While mammography is the gold standard for breast cancer screening, it is not as effective in women with dense breast tissue, which affects almost half of all women and younger women disproportionately. Inherited genetic changes, family history, and older age also increase risk of breast cancer.

Participants will be recruited from NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian/Columbia University Irving Medical Center, and the University of Calgary. They will have their blood drawn for the liquid biopsy and also complete standard-of-care screening with mammography or any other physician recommended procedures such as MRI or ultrasound, which can help screen dense breast tissue.

The primary objective is to measure the Syantra DX Breast Cancer test’s specificity, meaning the ability to correctly identify women who do not have a have breast cancer, and sensitivity, the ability to identify those who do have breast cancer. A positive test result, indicating that early cancer is present, will always require follow-up assessment with a pathologist who will use biopsy tissue to confirm a diagnosis, said Dr. Cristofanilli, associate director of precision medicine at the Sandra and Edward Meyer Cancer Center and scientific director at the Englander Institute of Precision Medicine, both at Weill Cornell Medicine.

Wider Access and Greater Convenience

“We want to make it easier for women to be screened for breast cancer,” Dr. Cristofanilli said. While mammograms are important for early detection, it is not necessarily the best test for women with dense breasts and younger women with genetic predisposition.

In addition, the researchers hope the test can be used worldwide in underserved populations or where access to standard imaging equipment isn’t readily available. A simple blood test used in a local doctor’s office that does not require travel to an imaging center could also help to improve regular screening.

“This new area of technology for detecting cancer in the blood is very important,” Dr. Cristofanilli said. “This is clearly an example of Weill Cornell Medicine researchers striving to be innovative and offering the best possible technologies to advance and improve the outcomes for the women that we serve.”