OmniSeq Comprehensive is a next-generation molecular sequencing assay that tests tumor DNA and RNA, identifying somatic variants in 144 genes. Learn More Here
OmniSeq Comprehensive is NYS CLEP approved – the highest standard for analytical validity in the United States.
OmniSeq Comprehensive delivers test results in approximately 10 to 15 days from date specimen is received

80%+ of tests are clinically actionable.

As little as 1/10 the standard tissue requirements of typical Next Generation Sequencing panels and requires minimal neoplastic tumor.

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Actual samples scanned at exactly the same magnification. Images have not been altered from original size proportions.

OmniSeq ComprehensiveSM

OmniSeq Comprehensive tests tumor DNA and RNA, identifying somatic variants in 144 genes:

Mutations

Single nucleotide polymorphisms (SNPs), insertions and deletions (indels)

Copy Number Variants

Segmental chromosomal gain (amplification) and loss (deletion)

RNA Fusions

Expressed gene fusion transcripts

OmniSeq KnowledgeBaseSM

Levels of evidence that drive clinical interpretation

OmniSeq ComprehensiveSM reports associations for variants that predict sensitivity or resistance to therapy, lack of response or poor prognosis independent of therapy, as well as open clinical trials for all tumor types as described in the OmniSeq KnowledgeBase. Variant associations in the Knowledgebase are updated monthly and generated from ongoing surveillance of high impact journal publications and clinical practice guidelines. Each individual publication is reviewed by trained annotators for association type and effect, and scored for biomarker validity. Variant associations are given an overall rank from limited evidence to consensus, which is updated monthly based on new evidence. Expert manual curation is performed for all journal publications and clinical practice guidelines that meet consensus evidence standards. Clinical trials are focused on personalized medicine trials where patients are selected for therapy based on detected variants.

OmniSeq ConnectSM

OmniSeq is dedicated to offering you and your patients the best therapeutic support possible. OmniSeq Connect  provides prescribers with the ability to track the status of a pending test. Providers will receive three tracking emails with updated status information pertaining to each sample during processing.

OmniSeq Comprehensive = 10 to 15 days from the date the specimen is received
Other tests = 14 to 30 days

Understanding Your Report

The OmniSeq Comprehensive report clearly defines the level of evidence for therapeutic associations, identifies important source publications, and provides a comprehensive list of clinical trial options to consider. Our OmniSeq CARES SM team can help with all questions about clinical report results or identify appropriate clinical trial access options.

Levels of Evidence:

Clear definition of how supporting evidence for results is ranked

Therapeutic Benefits:

Results details each detected variant with therapeutic associations including level of evidence and key publications

Precision Medicine Clinical Trials:

Open clinical trials are focused on studies where patients are selected for therapy based on their detected variants, including OmniSeq Priority Network Trials

About OmniSeq Comprehensive – Gene List

A next generation sequencing assay that uses multiplexed PCR-based DNA-seq and RNA-seq technologies to detect somatic variants in tumors for 144 genes to guide cancer therapeutic management. Learn More Here

 Specimen Collection

Blocks and slides must at a minimum be labeled with the pathology case number and part.

Reports and other provided materials must be labeled with the pathology case number and at least two patient identifiers such as name, medical record number or date of birth.

FFPE samples should be selected from:

  • Tumor from surgical resection or incisional biopsy
  • Needle core biopsy or fine need aspiration

Specimen Shipping

OmniSeq Universal Biospecimen kits are available upon request. Our Specimen Receiving Department will contact the pathology office designated on your order, and provide them with a packing sheet and shipping account information. The Specimen Receiving Department can be reached directly at 1-716-898-8654, or by contacting SpecimenReceiving@omniseq.com.

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. It is the shipper’s responsibility to comply with all state and federal regulations.

 Specimen Requirements (Please include the pathology report)

Recommended Specimen Submission

**Do Not Submit Decalcified Specimens or Cytology Smears**

Preferred specimens are FFPE blocks selected by a board-certified pathologist containing neoplastic and normal tissue where indicated.

If a block cannot be provided, see slide requirements below.

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.

It is recommended that USS are cut using standard DNA/RNA precautions (change microtome blade, wipe stage, never re-use blade for more than one case and remove floaters in water bath between cases).

Slide Requirements

OmniSeq Comprehensive AND Immune Report Card:

Send 20 unbaked, positively charged, unstained slides cut at 5 um.

  • Panel includes Microsatellite Instability (MSI)
    • Include NORMAL TISSUE: 10 (6 minimum) unbaked, positively charged, unstained slides cut at 5 um

Immune Report Card Only:

Send 15 unbaked, positively charged, unstained slides cut at 5 um

  • Panel includes Microsatellite Instability (MSI)
    • Include NORMAL TISSUE: 10 (6 minimum) unbaked, positively charged, unstained slides cut at 5 um

OmniSeq Comprehensive Only (OCP):

Send 10 unbaked, positively charged, unstained slides cut at 5 um.