Matrix-Bio's VeraMarker-BCR blood test predicts breast cancer recurrence 13 months before clinical diagnosis

Connie Krabbe understands the fear and foreboding breast cancer survivors feel when visiting their physicians for post-treatment check-ups. Two of her four sisters died of metastatic cancer related to breast cancer, enduring bone, brain, and ovarian cancer before succumbing to the disease in their early 50s.

“Catching the recurrence of cancer early can make all the difference in the world. It can save lives”

"The original diagnosis was devastating, but the panic they felt during follow-up visits was even worse. It was agony to find a recurrence," explains Krabbe, a retired insurance executive. "For me, it wasn't if the cancer would come back in my sisters, it was when and would there be time to treat it." Breast cancer recurrence occurs in more than 20 percent of breast cancer survivors.

So the news that a cancer recurrence detection blood test developed by Purdue Research Park-based company Matrix-Bio, Inc. has the potential to detect the recurrence of breast cancer a year in advance of currently available clinical diagnostic tests is something Krabbe applauds.

"Catching the recurrence of cancer early can make all the difference in the world. It can save lives," she says.

On Tuesday, October 19, the peer-reviewed journal, Cancer Research, a publication of the American Association of Cancer Research, published Matrix-Bio's findings, Early Detection of Recurrent Breast Cancer Using Metabolite Profiling, at www.cancerres.aacrjournals.org. Authored by Matrix-Bio founder and Purdue University chemistry professor Daniel Raftery with Vincent M. Asiago, Leiddy Z. Alvarado, Naraimhamurthy Shanaiah, G. A. Nagana Gowda, Kwadwo Owusu-Sarfo, and Robert Ballas, the study's findings support the importance of early breast cancer detection and recurrence.

Using metabolite-profiling methods, Matrix-Bio's VeraMarker™-BCR blood test correctly predicted a recurrence of breast cancer an average of 13 months before clinical diagnosis.

Matrix Bio's cancer monitoring test was developed using a powerful combination of nuclear magnetic resonance (NMR) and mass spectrometry analytical methods. The test also can be run on a single mass spectrometry platform. In the study, the test demonstrated the ability to identify metabolite signals between the recurrence of cancer and no evidence of cancer with a sensitivity of 86 percent and a specificity of 84 percent. This result is two times more sensitive than the current cancer monitoring blood tests CA 27.29 and CA 15-3. In addition, the BCR test opens up a window for second line therapy by more than one year compared to those tests.

"It's important to note that current blood tests do not pick up recurrence in the 20 percent of breast cancer survivors who do express the protein targeted by these CA tests," Raftery said.

For the more than 2.4 million breast cancer survivors in the United States and their physicians, the results of Matrix-Bio's VeraMarker-BCR blood test are extremely promising. "Knowing there's a test that can detect the recurrence of cancer far earlier, when the cancer is more treatable, should provide tremendous hope to breast cancer survivors and also relieve the tremendous worry they feel with each visit to their doctor. Its accuracy and early stage detection offer a much better window for treatment," Raftery continued.

Matrix-Bio's cancer monitoring test is non-invasive, simple to administer and non-threatening to patients. Blood is drawn from the patient and sent to a lab for analysis. If the test yields positive results, the oncologist will order additional tests such as a bone scan, MRI, CAT scan, chest X-ray, or liver blood tests to identify and locate the tumor. Women who have had ER+ breast cancers may be eligible to switch to a different chemotherapy regime, such as aromatase inhibitors.

Most breast cancers recur in the first three to five years. During this time women are closely monitored, visiting their oncologist once a quarter for up to three years and once a year afterwards. Breast cancer can come back in the treated breast or near the mastectomy scar or as a distant recurrence somewhere else in the body (metastatic breast cancer). The most common sites of metastasis include the lymph nodes, bones, liver, and lungs.

Matrix-Bio's VeraMarker-BCR test will now be clinically validated in a CLIA-licensed laboratory. The company's goal is to make the test commercially available in the United States by mid 2011.

Dr. Kathy Miller, a medical oncologist and associate professor of Medicine at the Indiana University Melvin and Bren Simon Cancer Center, commented on Matrix-Bio's findings, saying, "Truly early detection of breast cancer has been an elusive goal. This study offers hope for real progress."

A startup in the Purdue Research Park of West Lafayette, Ind., Matrix-Bio has received funding from Main Street Venture Fund, Fort Wayne, Ind., and Purdue University's Emerging Innovations Fund.

Raftery, like Krabbe, has experienced cancer in his own family, which serves as a powerful motivator for his research.

"The existing cancer recurrence tests are inadequate to meet the needs of a large and growing population of breast cancer survivors. Making a difference for the estimated 10 million women who are breast cancer survivors globally is the starting point for Matrix-Bio's VeraMarker Platform. In the field of metabolite molecular diagnostics blood tests for many forms of cancer that affect women and men."