General
Which Oncogene Science ELISA products are FDA-cleared?*
Only the IVD (In Vitro Diagnostic) ELISA products are FDA-cleared. RUO (Research Use Only) products are not. RUO products are for research use only. They are not for use in diagnostic procedures. See list below.
| Product | Item No. | Regulatory Status |
| HER-2/neu ELISA | 06489876 | In Vitro Diagnostic |
| EGFr ELISA | 06489930 | Research Use Only |
| uPA ELISA | 06489892 | Research Use Only |
| PAI-1 ELISA | 06489914 | Research Use Only |
| TIMP-1 ELISA | 06489973 | Research Use Only |
| CA IX ELISA | 06490025 | Research Use Only |
* FDA clearance does not denote official FDA approval. |
Are your ELISA Products Reimbursable?
Third party payers will only reimburse kits that are FDA-cleared for their intended use.
| Product | CPT Code | NLA* |
| HER-2/neu ELISA | 83950 | $89.99 |
* Centers for Medicare and Medicaid Services National Limitation Amount. This reimbursement information is being provided as a service to WILEX Inc. customers to assist in accurate reporting and billing for Oncogene Science ELISA tests. This information is based upon information from coding authorities and/or insurers on how it is appropriate to bill and report Oncogene Science tests in claims to third party insurers, such as Medicare. Specifically, this information was retrieved from the Centers for Medicare and Medicaid Services website at www.cms.gov, and is subject to change. WILEX Inc. makes no representations or warranties regarding the accuracy or completeness of the information on this website. There is no guarantee that any test will be covered and paid. Coverage varies depending upon the health insurer’s policies and the patient’s medical condition. It is the responsibility of the treating physician to indicate the patient’s condition, which is the basis for determining medical necessity and coverage. Actual payment amounts for covered tests can vary from state to state, and from payor to payor. Please contact your local Medicare carrier or other health plan for additional details on local policies and to ensure compliance with specific plan requirements. |
How many tests does a kit generate?
There are 38 test determinations per kit when samples are tested in duplicate. Generally, tests use 6 standards, 3 controls and 1 sample blank, each in duplicate. Test wells dedicated to these reagents reduce the number of wells available for samples.
What sample types are your ELISA products intended for?
All of the ELISA products we offer are intended for HUMAN serum and/or plasma samples only. However, refer to the IFU for the specific ELISA product in question.
