BC Detect, Serum Based Diagnostic Test For Breast Cancer Now Available

Armen Hareyan's picture
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Panacea Pharmaceuticals's serum-based breast cancer diagnostic test is now available from Panacea Laboratories. BC Detect is a simple blood test that should facilitate the identification of recurrence among women successfully treated for breast cancer. Panacea Laboratories, a division of Panacea Pharmaceuticals, is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The blood sample can be ordered by any physician and sent to Panacea for testing; sample and shipping requirements are available at www.panacea-labs.com.

Breast cancer is the most common type of cancer in women accounting for 26% of female cancers. One in every eight women will develop breast cancer in their lifetime, placing the lifetime risk at 13%. More than 200,000 new cases of breast cancer will be diagnosed in the United States in 2007 and upwards of 2 million women are currently breast cancer survivors. Five-year survival rates for breast cancer are 98% for localized disease, 83% for regionally spread and 26% for distantly spread cancer. However, 25% of all metastases occur more than 5 years after the initial diagnosis and thus survival rates decrease as time goes out to 10 years due to disease recurrence. Methods to detect initial presentation of breast cancer as well as recurrence rely on imaging modalities, including mammography and MRI. No serum biomarkers have been approved for either primary breast cancer screening or monitoring for disease recurrence primarily due to relatively low specificities and sensitivities. In asymptomatic women in remission from breast cancer the guidelines of the major oncologic organizations only suggest annual mammography for detection of new tumors.

BC Detect measures levels of human aspartyl (asparaginyl) beta-hydroxylase (HAAH), a cancer molecular marker, in blood. HAAH has been detected by immunohistochemical staining (IHC) in a broad range of cancers including breast cancer. In addition, HAAH protein levels in serum have been demonstrated to be highly sensitive and specific for cancer in hundreds of patients with a range of cancer types, including breast cancer. Increased levels of HAAH have been found in the serum of 96% of women with breast cancer (n=157). In women not known to have cancer, HAAH was essentially undetectable in serum (n=32, specificity = 91%). HAAH was elevated in serum from women with all stages of breast cancer; mean serum HAAH levels for stages I - IV were 19, 13, 21 and 15 ng/ml, respectively. In addition, serum from women currently in remission (n=35) following treatment for breast cancer were also analyzed and found to be negative for HAAH.

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"Measurement of serum HAAH levels using BC Detect has great promise as a diagnostic tool to monitor women with a history of breast cancer for disease recurrence", commented Pamela Jo Harris, MD, Vice President, Medical and Clinical Affairs at Panacea. "BC Detect, in conjunction with routine follow-up imaging modalities should facilitate earlier identification of recurrent disease and prompt initiation of appropriate therapy."

About Panacea's Oncology Platform

In addition to BC Detect, Panacea offers, PC Detect, a diagnostic test used in conjunction with PSA and digital rectal exam to identify patients with prostate cancer, LC Detect, a diagnostic test to aide in the detection of patients with lung cancer, and TK Sensesm, which determines whether white blood cells from patients with chronic myelogenous leukemia (CML) are sensitive or resistant to imatinib, the therapy of first choice for CML patients, prior to initiation of therapy.

The HAAH serum assay will be further developed as a diagnostic test for other types of cancer. Panacea is also pursuing the development of antibodies directed against HAAH as novel agents for the treatment of cancer with liver cancer as the first therapeutic indication. The Company is exploring both naked anti-HAAH antibodies as well as HAAH antibodies conjugated to chemotherapeutic agents and toxins. PAN-622 is an all-human sequence anti- HAAH monoclonal antibody that has demonstrated excellent efficacy in animals, and is currently in development as a cancer therapeutic.

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