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Provided by Labcorp

Tyruko® JCV Testing Program

TYRUKO® (natalizumab-sztn) is indicated as monotherapy for the treatment of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing remitting disease, and active secondary progressive disease, in adults. It is also used for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional CD therapies and inhibitors of TNF-α. Natalizumab products increase the risk of progressive multifocal leukoencephalopathy (PML).

The Anti-JCV Antibody test detects the presence of anti-JCV antibodies in the blood. While common and usually harmless in most people, the John Cunnigham Virus (JCV) can lead to the development of rare but serious progressive multifocal leukoencephalopathy (PML), a potentially life-threatening condition. The presence of anti-JCV antibodies is one of several risk factors for developing PML, including duration of natalizumab treatment and prior immunosuppressant use, that may be considered by physicians in a case-by-case risk-benefit analysis when considering natalizumab treatment. The estimated risk of developing natalizumab-associated PML is less than one percent.

What is the Tyruko JCV Testing Program?

A patient program providing no-cost Anti-JCV Antibody testing to eligible individuals that are being considered for—or are currently being prescribed natalizumab.
 

Who is eligible?

All patients living in the US who are receiving, or may receive treatment with natalizumab.

How do healthcare providers participate? 

Registration

To order testing and register for this program, healthcare providers should use their existing Labcorp account. If a provider does not have a Labcorp account, please click on the "Register" link below and our Labcorp JCV Program Support Team will respond to inquiries within 24 business hours.

For any Labcorp account set up questions, please contact the  Labcorp TYRUKO JCV Testing Program Support Team at jcvstp@labcorp.com.

Register

Test ordering

Complete the Tyruko JCV Testing Program test request form with appropriate Labcorp account information and all required patient information. The patient’s specimen may be collected in a clinic or at any of Labcorp's more than 2,200 patient service centers.

Schedule an Appointment

Receive results

Test results will be sent to the ordering provider within 7-10 days from the time the sample is received in the laboratory. Reports will be sent out by report delivery settings on their account.


Specimen instructions
 

164142

Anti-JCV Antibody Index

Sample type/volume: 1 mL Serum (preferred), Minimum 0.5 mL  
Please note: 0.5 mL does NOT allow for repeat testing.

Submission tube: Gel-barrier tube (preferred) or red top tube

Shipping instructions: Ship at room temperature

Methodology: Enzyme-linked immunosorbent assay (ELISA)

 

For questions related to disease management and the clinical impact of a test result, please refer to prescribing information. Adverse events suspected of being associated with the drug should be reported directly to Sandoz Pharmacovigilance at Sandoz, Inc. at 1-800-525-8747. You may also report adverse events directly to the FDA at 1-800-FDA-1088 OR www.fda.gov/medwatch

Tyruko® JCV Testing Attestation Statement

By participating in the Tyruko JCV Testing Program or by submitting the test request form, the healthcare provider (“You” or “Your”) is responsible for ordering testing under this program in accordance with Your own medical judgment and applicable laws. You understand that Sandoz will cover the cost of testing and shipping for eligible patients, and the testing will be performed by Labcorp. Sample collection charges may apply. You understand that Labcorp may share aggregated, deidentified metrics with Sandoz. You understand the eligibility criteria set forth above and have determined that the patient meets those criteria. The patient has been informed by You that Sandoz covers the cost of the testing, and the patient understands that they are under no obligation to purchase or use any Sandoz or Labcorp products or services.

Tyruko® is a registered trademark of Sandoz AG.