Aviara H/I^SM - FAQ

The following are frequently asked questions about H/I^SM

What is the H/I test?

H/I (HOXB13/IL17BR) is a molecular diagnostic test, performed on tumor tissue. 

• H/I - can be used to stratify ER+, breast cancer patients into low or high risk of recurrence based on estrogen signaling information
• H/I – utilizes small formalin-fixed paraffin embedded (FFPE) biopsies and is analyzed by RT-PCR
• H/I – has been validated in multiple clinical studies (see publications) in more than 2,300 patient samples; studies included both untreated and endocrine therapy treated patients

Studies have shown that H/I is independent of tumor grade, tumor size, and proliferation gene indices.

How is the H/I test performed?

The H/I test is performed on a breast biopsy. mRNA is extracted from the sample and levels of expression from the HOXB13 and IL17BR genes are evaluated and reported as a quantitative result.  Based on defined reference cut-points, a H/I test result is also correlated to a low or high risk of cancer recurrence.

When should the H/I test be used?

The H/I test should beused on ER+ breast cancer to stratify patients into low or high cancer recurrence groups based on estrogen signaling information.  

How accurate are the results?

H/I is a quantitative measurement of the gene expression ratio of HOXB13 and IL17BR to determine the risk of breast cancer recurrence.  Multiple validation studies have demonstrated that the H/I test provides prognostic information that is independent of established prognostic parameters, including ER/PR, tumor size, tumor grade, proliferation gene indices and age in both, untreated patients and patients treated with endocrine therapy.

How can the H/I test be ordered?

It can be ordered by a physician or other healthcare professionals. AviaraDx is a CLIA certified laboratory as well as the test developer.  AviaraDx will perform the test and send results back to the ordering physician and/or other healthcare professional.

How long does it take to get the results of the H/I test?

Test results are usually available 7-10 days after the tissue specimen is received by AviaraDx.  The results can only be released to the ordering physician and/or other healthcare professional.

How are test results reported?

The H/I report will provide a patient’s quantitative values of the HOXB13/IL17BR  ratio as well as the risk of recurrence category (low or high).

Does H/I determine whether a patient should receive chemotherapy?

H/I test results should be used in conjunction with other diagnostic findings to determine appropriate treatment options for ER+ breast cancer patients. Treatment is, among others, guided by the assessment of the patient’s risk of cancer recurrence and the patient’s potential benefit from endocrine therapy. In two recent clinical validation studies, a low H/I ratio predicted good response to adjuvant endocrine therapy and a high H/I ratio was associated with poor prognosis, in both untreated patients and patients treated with endocrine therapy.  A physician should determine whether endocrine therapy and/or chemotherapy are appropriate treatment choices.

Does the H/I test replace other standard laboratory tests for breast cancer?

No, the H/I test should be used in conjunction with other laboratory tests in the evaluation of breast cancer risk of recurrence. H/I provides clinicians with new estrogen signaling information related to the breast cancer.

Is H/I test covered by health insurance?

AviaraDx is working directly with providers and payers to provide reimbursement as quickly as possible.  Because this test is new, many insurance companies will first evaluate the test and then determine how to set their reimbursement policy.  AviaraDx works with patients and third party payers regarding coverage and reimbursement of the test.

Where can more information be found about the H/I test?

More information can be obtained through healthcare professionals and the AviaraDx website.  To request information or answers to questions you may have, please email or call our customer service department at 1-877-TUMORDX (886-6739).

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