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26380 Strata NGS

Strata NGS
Test Code: STRATSO
Synonyms/Keywords

Formalin-fixed paraffin embedded (FFPE) specimens

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)

Tumor tissue

DNA and RNA in solid tumors

Test Components

​​Includes results from genomic signatures:

• Tumor Mutational Burden (TMB)

• Microsatellite Instability (MSI)

Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/Tube​Acceptable Container/Tube​
​NoFFPE Tissue ​

One ​FFPE Tissue Block

 

Unstained FFPE Tissue Slide Set             10 slides

Strata Specimen collection Kit: Supplied in Specimen Lab Processing Department.

Refer to the Kit and the Collection Processing Instructions (below).

​ ​
Collection Processing Instructions

​Most recent Formalin-fixed paraffin embedded (FFPE) specimen is preferred. 

If patient has been treated with a targeted therapy, a post-therapy specimen is preferred. 

Tissue blocks or 10 x 5μm unstained slides are acceptable. Unused portion of blocks will be returned. 

Prepare only 1 block for shipment. 

Unstained slides should be positively charged and unbaked.

Blocks or slides with tissue fixed in 10% neutral-buffered formalin (for 6-48 hours of fixation per industry standard). 

Affix barcode on bottom of block. 

Air-dry slides. Baked slides may be rejected.

Specimen should be cut from block within 14 days of sending to Strata Oncology. Note: Specimens not meeting this criteria may not provide optimal results and/or may be rejected.

Refer to website for more detailed specimen submission instructions:   https://www.strataoncology.com

Acceptable Specimen Types

​Acceptable FFPE Specimens: 

• Primary tumor biopsy

• Surgical resection specimen

• Metastatic tumor biopsy

• EDTA-decalcified or non-decalcified bone samples

• Cytology cell block specimen

 

Specimen Stability Information

Refer to Kit and Collection Processing Instructions

Rejection Criteria

Non-air dried slides

Baked slides

Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Strata Oncology, Inc                                                     Monday through Saturday​7 daysNext Generation Sequencing
Reference Lab
Test Information

​StrataNGS is a clinically and analytically validated tissue-based comprehensive genomic profiling (CGP) test that assesses DNA and RNA in solid tumors. The test is optimized for small tumor tissue samples to provide more patients the opportunity to benefit from precision medicine. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions.

 437 gene, pan-solid tumor, next generation sequencing assay

• Detects mutations, copy number variations (amplification and deep deletions), insertions and deletions in over 417 genes

• Fusion events are detected across 59 driver genes by RNA sequencing

• Microsatellite instability status and tumor mutation burden are included on every test report

• The test is optimized for small formalin fixed paraffin embedded (FFPE) tumor tissue samples ( ≥ 2mm2 surface area)

Reference Range Information

An interpretive report will be provided

Interpretation

​An interpretive report will be provided

Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
81479    ​1Unlisted molecular pathology procedure
Synonyms/Keywords

Formalin-fixed paraffin embedded (FFPE) specimens

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)

Tumor tissue

DNA and RNA in solid tumors

Test Components

​​Includes results from genomic signatures:

• Tumor Mutational Burden (TMB)

• Microsatellite Instability (MSI)

Ordering Applications
Ordering ApplicationDescription
​COM​STRATA NGS
​Cerner​STRATA NGS
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/Tube​Acceptable Container/Tube​
​NoFFPE Tissue ​

One ​FFPE Tissue Block

 

Unstained FFPE Tissue Slide Set             10 slides

Strata Specimen collection Kit: Supplied in Specimen Lab Processing Department.

Refer to the Kit and the Collection Processing Instructions (below).

​ ​
Collection Processing

​Most recent Formalin-fixed paraffin embedded (FFPE) specimen is preferred. 

If patient has been treated with a targeted therapy, a post-therapy specimen is preferred. 

Tissue blocks or 10 x 5μm unstained slides are acceptable. Unused portion of blocks will be returned. 

Prepare only 1 block for shipment. 

Unstained slides should be positively charged and unbaked.

Blocks or slides with tissue fixed in 10% neutral-buffered formalin (for 6-48 hours of fixation per industry standard). 

Affix barcode on bottom of block. 

Air-dry slides. Baked slides may be rejected.

Specimen should be cut from block within 14 days of sending to Strata Oncology. Note: Specimens not meeting this criteria may not provide optimal results and/or may be rejected.

Refer to website for more detailed specimen submission instructions:   https://www.strataoncology.com

Acceptable Specimen Types

​Acceptable FFPE Specimens: 

• Primary tumor biopsy

• Surgical resection specimen

• Metastatic tumor biopsy

• EDTA-decalcified or non-decalcified bone samples

• Cytology cell block specimen

 

Specimen Stability Information

Refer to Kit and Collection Processing Instructions

Rejection Criteria

Non-air dried slides

Baked slides

Test Components

​​Includes results from genomic signatures:

• Tumor Mutational Burden (TMB)

• Microsatellite Instability (MSI)

Reference Range Information

An interpretive report will be provided

Interpretation

​An interpretive report will be provided

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation
​Strata Oncology, Inc                                                     Monday through Saturday​7 daysNext Generation Sequencing
Reference Lab
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)
QuantityDescriptionComments
81479    ​1Unlisted molecular pathology procedure
For most current information refer to the Marshfield Laboratory online reference manual.