Invitae Amyotrophic Lateral Sclerosis with C9orf72 Panel
Panel analyzes genes associated with ALS, including C9orf72 repeat expansion, the most common genetic cause. Broad testing supports diagnosis, prognosis, and counseling.
Accessed through the ALS Identified Sponsored Testing Program•Sponsored by Biogen•Performed by Invitae | Labcorp
Designed to support clinical decision-making and ordering in your practice.
For healthcare providers
Overview
ALS Identified provides clinicians with access to the Invitae Amyotrophic Lateral Sclerosis with C9orf72 Panel, a 22-gene NGS panel, at no cost to the patient, provider, or payer. Sponsored by Biogen, the program supports diagnostic clarity, prognosis refinement, family risk assessment, and identification of candidates for genotype-driven clinical trials. Ordering carries no prescribing or purchase obligation.
When to consider this test
Patient selection
- To qualify, all of the following must be met:
- Individual is 18 years of age or older
- Individual lives in the U.S. or Puerto Rico
- Individual meets one of the following:
- Individual with clinical diagnosis of amyotrophic lateral sclerosis (ALS)
- Asymptomatic individual with known family history of amyotrophic lateral sclerosis (ALS)
Workflow
How to use this program
- 1
Order Test
Discuss testing with the eligible patient, obtain consent, and place the order through Invitae’s online portal.
- 2
Collect Sample
Collect the patient’s specimen using an Invitae kit and return it. Use the provided label to ship most samples at no extra charge from the US and Canada.
- 3
Review Results
Receive results online and use Invitae’s resources to guide your discussion 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 Invitae | Labcorp, a CLIA-certified laboratory (CLIA 05D2040778). 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 are appropriate for the ALS Identified sponsored genetic testing program?
ALS Identified is designed for individuals in the US and Puerto Rico who have a diagnosis of ALS or a family history of ALS. If your patient meets the program's eligibility criteria, testing is fully sponsored by Biogen at no charge to the patient, the ordering provider, or the payer.
What does the ALS Identified panel test and how many genes does it cover?
The program utilizes the Invitae Amyotrophic Lateral Sclerosis with C9orf72 Panel, which covers 22 genes associated with ALS, analyzed via next-generation sequencing. The panel is performed by Invitae at Labcorp and is designed to support diagnostic confirmation, prognostic insight, and clinical trial eligibility assessment.
What specimen types are accepted for the ALS Identified program and what is the turnaround time?
ALS Identified accepts whole blood, saliva, buccal swab, or extracted gDNA. Turnaround time is 10 to 21 days from specimen receipt. Multiple specimen options help accommodate patients with varying clinical circumstances, including those with limited mobility.
Is there any cost or purchase obligation when ordering through ALS Identified?
There is no cost to the patient, provider, or payer for testing through ALS Identified. Biogen sponsors all testing costs. Ordering through the program carries no prescribing or purchase obligation of any kind.
Does the ALS Identified program support genetic counseling and family risk assessment?
ALS Identified is designed to facilitate family counseling and cascade risk assessment in addition to supporting the index patient's care. The program's broad 22-gene panel enables identification of hereditary variants that may inform at-risk relatives and guide referral for genetic counseling.
Which patients are eligible for ALS Identified Amyotrophic Lateral Sclerosis genetic testing?
Patients may qualify for ALS Identified if they meet the program's eligibility criteria:
- Patient is 18+ and resides in the US or Puerto Rico.
- Patient has a confirmed ALS diagnosis, or a family history of ALS, including cases where ALS appears sporadic but a hereditary cause is still possible.
- Provider agrees to order testing as part of clinical evaluation and to counsel the patient on testing and results.
See an issue with this program?