OmniSeq AdvanceSM Assay

OmniSeq AdvanceSM Assay

The OmniSeq Advance assay is a single test that combines the benefits of both targeted immunotherapy and genomic biomarkers to inform the therapeutic management of cancer patients under consideration for checkpoint inhibition or targeted therapy. The assay measures the most significant protein, RNA and DNA biomarkers as part of a result report that compares the relative effectiveness of personalized treatments based on curated and summarized evidence.

Methodology

The OmniSeq Advance Assay uses two different testing methodologies: IHC and DNA-sequencing, RNA-sequencing and MSI performed by NGS. 

Turnaround Time

15-20 days

CPT

Call client services

Disease

Different cancer types

Bladder Cancer

Breast Cancer

Colorectal Cancer

Gastroesophageal cancer

Lung Cancer

Melanoma

Non-Small-Cell Lung Cancer (NSCLC)

Ovarian Cancer

Prostate Cancer

Specimen

FFPE tissue block preferred.  Unstained slides accepted.  

Volume

Block is preferred, or send 20 unbaked, positively charged, unstained slides cut at 5 μm.

Special Instructions

Primary tumor type and stage of disease required and needs to be included in the test requisition.  Please include the pathology report when submitting a sample.  If a pathology report is not received with the sample, testing will be delayed.

Causes for Rejection

Tumor block containing insufficient tumor; broken or stained slides; decalicified bone biopsies; cytology smears.  Specimens with very small amounts of tumor and/or less than requested number of slides will be accepted with the caveat that complete testing may not be possible.

Storage Instructions

FFPE blocks are stored at room temperature and shipped with no special precautions, except when daily outside temperatures exceed 35°C, and then ship with cool packs to avoid paraffin meltdown.

Test Includes

OmniSeq AdvanceSM includes PD-L1( FDA-approved), CD8 by IHC, microsatellite instability (MSI), tumor mutational burden (TMB) , RNA-sequencing of over 50 critical immune markers to characterize the tumor micro-environment (TME), and somatic genomic profiling of 144 genes.

Use Statement

Only OmniSeq Advance synthesizes the most relevant biomarkers for selecting targeted therapies and provides a comprehensive immune profile to characterize DNA damage (TMB and MSI), TILs, T-cell receptor signaling, and other markers of immune stimulation and escape. A single test with actionability that reaches 99% by combining indicated and contraindicated biomarker results for targeted therapy and immunotherapy.1

References

1.  Based on OmniSeq Internal data

CPT Codes

The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and LabCorp may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.

Profile Policy

LabCorp's policy is to provide physicians, in each instance, with the flexibility to choose appropriate tests to assure that the convenience of ordering test combinations/profiles does not prevent physicians who wish to order a test combination/profile from making deliberate informed decisions regarding which tests are medically necessary. All the tests offered in test combinations/profiles may be ordered individually using the LabCorp test request form.

Please remember that (1) when ordering tests for which Medicare or Medicaid reimbursement is sought, the physician should only order those tests that the physician believes are medically necessary for each patient, (2) that using a customized profile may result in ordering tests for which Medicare or Medicaid will deny payment, (3) that the physician should only order individual tests or a less inclusive profile where not all the tests in the customized test combination/profile are medically necessary for an individual patient, and (4) that the United States Department of Health and Human Services, Office of Inspector General, takes the position that a physician who orders medically unnecessary tests may be subject to civil penalties.

LabCorp encourages clients to contact their local LabCorp representative or LabCorp location if the testing configurations shown here do not meet individual needs for any reason, or if some other combination of procedures is desired.

Investigational Procedures

Some of the individual tests and profile test components listed in this Directory may be considered by Medicare or other insurance carriers as investigational procedures, and therefore, the test may not be payable by the carrier as a covered benefit for the patient. Medicare patients must be informed of this possibility when the physician orders tests that may fall into this category. Affected patients must be asked to sign an Advance Beneficiary Notice, agreeing to be financially responsible if the service is denied by the carrier. Additionally, for other insurance plans, physicians should inform the patient that the service(s) may not be covered by their private insurance plan and, if so, they will be financially responsible for payment. If the patient declines to accept financial responsibility, please do not order the test(s).

As with all clinical assays, results of these tests should be used only in conjunction with other medically established diagnostic elements (eg, symptoms, history, clinical impressions, results from other tests, etc). Physicians should use all the information available to them to diagnose and determine appropriate treatment for their patients. In order to obtain a current list of the procedures that may be considered investigational by Medicare or other insurance carriers, please contact your local LabCorp representative.