Amplify Hearing Loss Panel
A no-cost genetic blood test analyzing 269 genes associated with childhood auditory neuropathy spectrum disorder.
Accessed through the Amplify Sponsored Testing Program•Sponsored by Regeneron•Performed by Prevention Genetics
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
The Amplify program provides sponsored access to a comprehensive 269-gene hearing loss panel for patients with a confirmed auditory neuropathy diagnosis. Identifying a genetic etiology can meaningfully inform clinical decision-making and long-term management planning. Regeneron covers the full cost of testing, and only de-identified patient data is shared with program partners to support prevalence insights and therapeutic research.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Patient is in the U.S.
- Patient is less than 18 years of age
- Medical history consistent with auditory neuropathy diagnosis:
- Absent or highly abnormal ABR
- Presence of OAEs and/or cochlear microphonic (CM)
Workflow
How to use this program
- 1
Eligibility Criteria
Determine if the individual meets eligibility criteria and discuss the test.
- 2
Order Test
Order the test using the test requisition form link.
- 3
Collect Sample
Collect a specimen in the collection tube. (Label containers with patient name, DOB, or ID; include two identifiers. Specimens accepted Mon–Sat. Holiday schedules posted one week ahead.)
- 4
Test Processing
The test is processed at PreventionGenetics, and results are sent to the ordering provider about 18 days after the lab receives the specimens and required paperwork. The provider will review results with the patient.
Billing overview
Program billing
For eligible patients, the sponsor has arrangements with the laboratory that may reduce or cover some or all of the patient's out-of-pocket cost. Actual cost and patient responsibility vary by program criteria. Refer to lab or sponsor materials for details.
Quality & privacy
Laboratory quality & data handling
Testing is performed by Prevention Genetics, a CLIA-certified laboratory (CLIA 52D2065132) and College of American Pathologists (CAP) certified laboratory (CAP 7185561). Your sample is processed using validated methods and quality controls to support reliable genetic results.
Your health information is handled under privacy and security practices that are intended to align with applicable regulations. For program- and lab-specific details, review the privacy information provided by the laboratory and sponsor.
FAQ
Frequently asked questions
Which patients with auditory neuropathy are appropriate for the Amplify sponsored genetic testing program?
The Amplify program is designed for patients in the United States who have a confirmed diagnosis of auditory neuropathy and who meet the program's established eligibility criteria. Clinicians should review the specific diagnostic requirements on the program's ordering page to confirm patient eligibility before placing an order.
What does the Amplify Hearing Loss Panel cover and what methodology is used?
The Amplify Hearing Loss Panel interrogates 269 genes associated with hearing loss using next-generation sequencing (NGS). The test is performed by Prevention Genetics, a CAP/CLIA-accredited laboratory. This broad panel approach is designed to maximize diagnostic yield across known genetic etiologies of auditory neuropathy and related hearing loss conditions.
What specimens are accepted and how are collection kits obtained for the Amplify program?
The Amplify program accepts whole blood, saliva, or buccal swab (OCD-100) specimens. Sample collection kits are provided at no charge and can be ordered directly through Prevention Genetics when placing the test order. Kits are shipped to the ordering clinician's facility.
What is the turnaround time for results from the Amplify Hearing Loss Panel?
The Amplify Hearing Loss Panel has a turnaround time of 2 to 3 weeks from specimen receipt at Prevention Genetics. Results are reported back to the ordering clinician through the laboratory's standard reporting channels.
Is there any cost or prescribing obligation associated with ordering through the Amplify program?
There is no cost to the patient or the ordering clinician for testing through the Amplify program. Regeneron sponsors the full cost of testing. Ordering the test carries no purchase or prescribing obligation of any kind.
How is patient data handled in the Amplify auditory neuropathy testing program?
Only de-identified patient data may be shared with Amplify program partners. This data can contribute to prevalence insights and inform therapeutic research related to hearing loss. Individual patient results remain confidential and are reported solely to the ordering clinician.
Which patients are eligible for Amplify Auditory Neuropathy genetic testing?
Patients may qualify for Amplify if they meet the program's eligibility criteria:
- Patients under 18 years of age with confirmed or suspected auditory neuropathy.
- Medical history is consistent with auditory neuropathy, including:
- Absent or highly abnormal ABR.
- Presence of OAEs and/or cochlear microphonic (CM).
See an issue with this program?