FAQs for providers

 

Any consenting adult (19 and older) may initiate an order for the Kailos Genetics test for cancer risk. As a part of this initiative, women and men residing in Madison, Jackson, Limestone, Marshall and Morgan Counties who are between the ages of 28 to 30 years old at any point during the initiative will be provided access to this test at no cost. All adults in the same geographic region will be able to access this test at a reduced cost of $129. This year there is also an option to GIFT A TEST to those 19 and older that live in the 48 states other than New York and Maryland.

Did their previous testing include all of the genes in this test? While it is highly unlikely that another informative gene change would be identified, it is possible. These patients would not be excluded from this testing and initiative. However, if there is a clinical reason for pursuing additional cancer risk testing it may be beneficial for the patient to discuss testing options with a clinical genetic counselor outside of this initiative.

The Information is Power test looks at several dozen genes associated with increased risk for breast, ovarian, colon, and many other cancers. The test looks at these genes to see if there are any identifiable genetic changes in them that would indicate an increased risk of cancer development. The Kailos hereditary cancer screening test can tell you if you carry the BRCA1 and BRCA2 gene mutations that are strong risk signs for hereditary breast and ovarian cancer. It also looks for changes in 30 additional genes, including APC, ATM, BARD1, BMPR1A, BRIP1, CDH1, CDKN2A, CHEK2, EPCAM, FH, FLCN, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, PALB2, PMS2, PTEN, RAD50, RAD51C, RAD51D, RINT1, SDHB, SMAD4, STK11, TP53, VHL, and XRCC2, to provide information about risks related to breast, ovarian, colon and endometrial (uterine) cancers.

Beginning November 7, 2019, participants may self-initiate the test by visiting information-is-power.org. This does not require an office visit, and the sample collection (a buccal swab) will take place at the participant’s home once his or her kit arrives in the mail. The participant will be required to list his or her healthcare provider on the test requisition. An authorization form will then be faxed to the listed healthcare provider’s office which must be signed and returned to Kailos Genetics in order for the healthcare provider to receive results.

If you choose not to authorize testing, the medical director of Kailos Genetics will review the requisition form and authorize testing for eligible individuals. If you do not authorize testing, you will not receive a copy of your patient’s results unless your patient chooses to share them with you.

If you authorize testing for your patient, you will be faxed and/or emailed a link to access the results electronically through the Kailos Genetics website once they are available. You will receive results two business days before they are released to your patient.

If your patient is positive for a pathogenic change in one of the number of genes tested through this panel, this means that he or she has a known increased risk for one or more cancers compared to the general population. The specific cancers and risks depends on the particular gene and variant identified. The patient will receive a phone call from a genetic counselor the same day that results become available to the patient. You are encouraged to reach out to your patient before this, as you will have received the results two days prior. The conversation with this genetic counselor is not intended to replace a clinical genetic counseling appointment, which will be recommended for any individual with a positive result. Clinical genetic counseling will be the best opportunity for this individual to understand the results in the context of his or her family and medical history and also to receive medical management guidelines. For individuals local to the Huntsville area, Clearview Cancer Institute accepts both self and physician referrals for new genetic counseling patients at 256-327-9597.

A negative test result does not necessarily mean your patient has a reduced risk to develop cancer. A clinical genetic counseling appointment to pursue individualized risk assessment and medical management recommendations may still be appropriate for individuals with a negative result on this test – especially if there is a strong family history of cancer. Additionally, a negative result on this test does not preclude the need for future genetic testing if clinically indicated. At a minimum, general population cancer screening guidelines should continue to be observed by your patient, with increased screening implemented when appropriate based on individual cancer risk.

Kailos Genetics will NOT return benign variants and variants of uncertain significance through this initiative. Variants of uncertain significance are identified gene variants for which the clinical significance is not known, usually because current data fails to strongly indicate whether the variant is benign or pathogenic (risk causing). Because human genetic variation is common, these VUSs are not automatically presumed to be pathogenic and are instead treated as a negative result until more is known about their impact on risk. Only those variants that are thought to increase cancer risk and/or impact medical management as of the date of the report generation will be reported.

For general questions related to the Information is Power initiative, email informationispower@hudsonalpha.org or call 256-327-9597. For questions regarding a specific patient participating in the program, contact Kailos Genetics at 256-327-9800; 1-866-833-6865; or support@kailosgenetics.com.