CLINICAL DATA PGxHEALTH DIVISION
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Clinical Data, Inc. Reports First Quarter Fiscal Year 2011 Operational and Financial Results
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Frequently asked questions

Who should be tested?
The FAMILION tests are most useful for patients with a strong clinical suspicion of disease or family members of a patient with a defined mutation.

What specimen is required?
The FAMILION tests require two 4 ml lavender top tubes (EDTA) of whole blood.

What is the sensitivity of the tests?
It is estimated that the FAMILION test will detect mutations in up to 75-80% of the cases of LQTS, 65-75% of the cases for CPVT, 25% of the cases of Brugada Syndrome, 50-60% of HCM, 40-50% of ARVC, and 25% of DCM.

How long will it take to get test results?
Once the analysis begins, test results should be available in approximately 4-6 weeks for index tests and approximately 4 weeks for family specific tests. They will be sent directly to the ordering physician.

Where are the tests available?
The FAMILION Tests are available in all 50 states. The FAMILION CPVT Test requires written approval from the New York State Department of Health prior to testing. Please contact Customer Service at 877-2-PGxHealth for a copy of the NY Department of Health form.

The FAMILION tests are also available internationally.  Please contact our Customer Service Department for information on how to order.

How does the Genetic Information Nondiscrimination Act (GINA) affect patients?
The Genetic Information Nondiscrimination (GINA) Act of 2008 put protections in place so that health insurance providers and employers are prohibited from requesting, requiring, or using genetic information to discriminate in any way against members or employees. The first set of GINA protections covering nondiscrimination by health insurance providers became effective in May 2009. The second set of GINA protections covering employers became effective in November 2009.

Will insurance pay for the test?
PGxHealth will assist each patient by working with their insurance provider to pre-authorize services and determine benefit information upon request.  PGxHealth will contact the patient with this information prior to the initiation of testing.  PGxHealth will be quoted an estimate of coverage from the insurance carrier and cannot guarantee reimbursement.  It is important to remember that your insurance provider may not cover these services, or may only pay up to usual and customary rates, and you are ultimately responsible for all costs of this test. Learn more about the changing reimbursement landscape.

For assistance, please call FAMILION Customer Service  toll free at 1(877)-2-PGx-Health or 1 (877) 274-9432 between 9:00 am and 6:30 pm Eastern Time.

1-877-2-PGXHEALTH (877-274-9432)