80%+ of tests are clinically actionable.
OmniSeq Comprehensive tests tumor DNA and RNA, identifying somatic variants in 144 genes:
Single nucleotide polymorphisms (SNPs), insertions and deletions (indels)
Copy Number Variants
Segmental chromosomal gain (amplification) and loss (deletion)
Expressed gene fusion transcripts
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 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
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
OmniSeq Comprehensive requires as little as 1/10 the tissue requirement as standard-next generation sequencing panels.
- Tumor from surgical resection or incisional biopsy
- Needle core biopsy
- Cell pellet from FNA biopsy
- Cytology block- smears are not acceptable
- Decalcified specimens are not suitable for testing
OmniSeq Comprehensive Universal Biospecimen kits are available upon request. All shipments must include a copy of the pathology report. 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.
|Tissue Submission Guidelines:||All 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. PLEASE INCLUDE THE PATHOLOGY REPORT.|
|Recommended Specimen Submission:||**DO NOT SUBMIT DECALCIFIED SPECIMENS**
The preferred specimen is at least one FFPE block with tumor. If a block cannot be provided, send 10 unbaked positively charged unstained slides (USS) cut at 5 um. Note: Specimens with very small amounts of tumor and/or less than 10 USS will be accepted with the caveat that complete testing may not be possible. Specimens should be selected by a board-certified pathologist and should contain neoplastic tissue.
*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).
|Shipping Requirements:||FFPE blocks and/or USS may be shipped using the OmniSeq Comprehensive Universal Biospecimen kit. A copy of the pathology report and this completed specimen packing sheet must be included.|
|Transportation Requirements:||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.|