New molecular oncology tests for metastatic and breast cancer improve patient treatment.

Three new oncology tests for classifying metastatic cancer and identifying patients with estrogen receptor positive (ER-positive) breast cancer are now available. AviaraDx's new tests will help physicians select treatment regimens that are best matched for their patients.

CancerTYPE ID[TM], a molecular cancer classifier, will help physicians quickly and accurately diagnose primary sites of metastatic tumors, and thus best select appropriate treatment. "The test measures the expression of 92 genes, compares the result with a reference dataset and predicts the cancer type and its origin based on nearest matches," said AviaraDX CEO Toni Schuh, PhD. The test is capable of classifying 39 tumor types as well as 64 cancer subtypes.

"CancerTYPE ID[TM] was created and designed to help oncologists more effectively treat patients with metastatic cancer when the type of cancer appears uncertain," said Schuh. "This uncertainty can range from the need for a differential diagnosis (e.g., lung versus breast origin) to a complete lack of classification (cancer of unknown primary."

Studies have shown the accuracy rate for this test to be 87 percent, which is much higher than the 20 percent to 30 percent accuracy rate achieved with traditional methods of cancer of unknown primary classification. "CancerTYPE ID[TM] is an objective and quantitative test to classify cancer, which is independent of and complementary to clinical history, imaging or IHC results," said Dr. Schuh.

The CancerTYPE ID[TM] test may decrease the diagnosis time--often four to six weeks or more in standard practice--for a patient with metastatic cancer. "This is particularly important as life expectancy for these patients is typically less than one year," said Schuh. "With the advent of more and more targeted therapies, knowing the tumor or tissue of origin may allow for a more specific therapeutic regimen to be given to these patients."

Two new tests for breast cancer patients--H/I[TM] and MGI[TM] (Molecular Grade Index)--will help physicians determine the best treatment for patients with ER-positive, node-negative breast cancer. The two tests measure two distinct aspects of tumor biology that enable objective assessment of the risk of reoccurrence.

About 10 percent to 20 percent of patients with ER-positive breast cancer will relapse within five to 10 years. The H/I[TM] test will help physicians determine which patients are most likely to relapse, enabling oncologists to recommend more aggressive regimens to help improve their patients' chance of a positive outcome. The MGI[TM] test will allow oncologists to better determine whether an intermediate tumor--over 50 percent of breast tumors--is more like low grade or high grade. Correct assessment is important as it will determine which patients are more likely to need and benefit from chemotherapy.

"H/I[TM] can predict how well a patient will respond to endocrine therapy, or how resistant her tumor may be," said Schuh. "MGI[TM] can identify those patients with higher grade tumors who are more likely to be chemo-sensitive and benefit from that therapy, should the oncologist believe it is warranted."

The CancerTYPE ID[TM] and H/I[TM] tests are New York-state approved and are available through the company's CAP-certified CLIA laboratory. Both tests can utilize small formalin-fixed and paraffin-embedded (FFPE) tissue samples, which are easily available from imaging-guided needle biopsies.

"Each of these tests is valued at between $2,000 and $3,000," said Schuh. "Insurance reimbursement has been reasonable, and we are hopeful that as we further establish the clinical utility of these tests, we will be able to get actual billing codes for each of these that will facilitate the billing and payment process. AviaraDx is committed to working with the third-party payers to validate both the utility and value of these tests."

Molecular cancer diagnostics can play an important role in personalizing oncology medicine, which in turn improves patient treatment and prognosis. AviaraDx, Inc. discovers, develops and commercializes new molecular diagnostic tests in oncology, enabling physicians to personalize cancer treatment through better understanding of the molecular biology underlying a patient's tumor.

This edition of Health was prepared by Katie Barge.