October 28, 2013

Centers for Medicare and Medicaid Services approved the serum based HER-2/neu test for reimbursement under Medicare Part B

Pittsfield, MA – With the recent acquisition by Nuclea Biotechnologies, Inc. of Wilex Inc. (Oncogene Science), the company will begin its first foray into GMP (Good Manufacturing Practice) manufacturing and marketing of the 510(k)-cleared HER-2/neu blood test out of their facility in Cambridge, MA. The test is available as an In Vitro Diagnostic (IVD) in the US, Canada, and Europe (CE MARK). The HER-2/neu test is a blood test used to monitor women with metastatic breast cancer that is minimally invasive, inexpensive, and can be used to track disease progression or regression.

The Centers for Medicare and Medicaid Services approved the serum HER-2/neu test for reimbursement from Medicare Part B. The American Medical Association has approved a unique Current Procedural Terminology (CPT) code [HER-2/neu oncoprotein: 83950] for HER-2/neu oncoprotein testing for most health insurance programs.

In 2013, there were 232,340 new female breast cancer cases, making it the most frequently diagnosed cancer in women. The HER-2/neu test can be used to monitor patients with metastatic breast cancer. Those who overexpress HER-2/neu protein in the tumor tend to have a worse prognosis and a more aggressive disease that can resist certain types of chemotherapy. The blood test works by measuring the portion of HER-2/neu protein that is outside the surface of the cell, and that is released into the blood stream.

For the test to be effective doctors will establish a baseline level of the protein, and all patients with a HER-2/neu level greater than or equal to 15ng/mL should continue to be monitored. Increasing levels in serum can reflect disease progression while decreasing levels can reflect treatment response or stable disease.

"When we first developed the test, oncologists were using traditional tumor marker tests, such as CEA and CA15-3; however, this test provides specific quantitation of the circulating HER-2 protein," said Nuclea’s new Chief Scientific Officer Dr. Walter Carney. "The world has changed. Now early detection is the key. While before it was necessary to have the right drug for the right patient, this test could allow us to find the right drug for the right patient at the right time, and has become even more relevant since the advent of targeted drugs and personalized medicine."

"October is National Breast Cancer Month, and I think people sometimes forget about the person with a diagnosis of cancer, and only focus on the cancer patient," said Patrick Muraca, President and CEO of Nuclea. "This test is unique in monitoring people with the disease as it is less expensive and minimally invasive compared to other testing and biopsy methods. As Nuclea continues to add to our portfolio of diagnostic tools and tests, we will continue to engage with advocacy groups and other stakeholders to provide the best quality of care for people with cancer."

Nuclea Biotechnologies will be a participating vendor at the San Antonio Breast Cancer Symposium occurring from December 10th to the 14th. The goal of the symposium is to provide experimental biology, etiology, prevention, diagnosis, and therapy information on breast cancer and premalignant breast disease to an international audience.


Nuclea Biotechnologies, Inc. -- is headquartered in Pittsfield, Massachusetts with additional operations in Worcester and Cambridge, Massachusetts. Nuclea has developed and is commercializing unique diagnostic tests for colon, breast, leukemia, lung and prostate cancer. Nuclea also performs research leading to novel molecular oncology companion diagnostics for the pharmaceutical and biotechnology industries.


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