Molecular testing is a standard-of-care diagnostic for individuals with non-small cell lung cancer. In this test specific episode of the "Answers From the Lab" podcast, Ying-Chun Lo, M.D., Ph.D., explains how Mayo Clinic Laboratories' new MayoComplete Lung Cancer Panel updates a previous assay to better guide clinical decision-making.

"This new assay includes almost all genetic and genomic alterations that are currently associated with FDA-approved targeted therapy for lung cancer — in particular, non-small cell lung cancer," Dr. Lo says. The assay also assesses microsatellite instability, a biomarker for response to checkpoint inhibitor treatment.

The mid-sized lung panel provides more information than single-gene assays and faster results than a comprehensive solid-tumor panel covering hundreds of genes. Mayo Clinic Laboratories validated the new MayoComplete Lung Cancer Panel for use with several types of surgical and cytologic specimens.

"The panel has a very reasonable turnaround time and relatively low material requirements," Dr. Lo says. "We believe it will be the best go-to molecular test for lung cancer in daily community practice."

Listen to learn more about Mayo Clinic Laboratories' updated MayoComplete Lung Cancer Panel.

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Testing

MCLNG | MayoComplete Lung Cancer Panel

MCLNM | MayoComplete Lung Cancer Mutations

MCLNR | MayoComplete Lung Rearrangements

Useful information

MCLNG | MayoComplete Lung Cancer Panel

• Diagnosis and management of patients with lung cancer
• Assessment of microsatellite instability
• Validated on cytology specimens

MCLNM | MayoComplete Lung Cancer Mutations

• Diagnosis and management of patients with lung cancer
• Assessment of microsatellite instability
• Validated on cytology specimens

MCLNR | MayoComplete Lung Rearrangements

• Identifying lung tumors that may respond to targeted therapies by simultaneously assessing multiple genes involved in rearrangements resulting in fusion transcripts
• Diagnosis and management of patients with lung cancer

Specimen requirements

MCLNG | MayoComplete Lung Cancer Panel

This assay requires at least 20% tumor nuclei

• Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 360mm(2)
• Minimum amount of tumor area: tissue 72mm(2)
• These amounts are cumulative over up to 15 unstained slides and must have adequate percent tumor nuclei
• Tissue fixation: 10% neutral buffered formalin, not decalcified

For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing. In this document, the sizes are given as 4mm x 4mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3mm x 1mm x 10 slides: approximate/equivalent to 36mm(2).

Preferred:

• Specimen Type: Tissue block
• Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue

Acceptable:

• Specimen Type: Tissue slide
• Slides: 1 Stained and 10 unstained
• Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides wit 5-micron thick sections of the tumor tissue

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block
Additional Information: Unused unstained slides will not be returned

MCLNM | MayoComplete Lung Cancer Mutations

This assay requires at least 20% tumor nuclei

• Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 216mm(2)
• Minimum amount of tumor area: tissue 36mm(2)
• These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei
• Tissue fixation: 10% neutral buffered formalin, not decalcified

For specimen preparation guidance, see Tissue Requirement for Solid Tumor Next-Generation Sequencing. In this document, the sizes are given as 4mm x 4mm x 10 slides as preferred: approximate/equivalent to 144 mm(2) and the minimum as 3mm x 1mm x 10 slides: approximate/equivalent to 36mm(2).

Preferred:

• Specimen Type: Tissue block
• Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block with acceptable amount of tumor tissue

Acceptable:

• Specimen Type: Tissue slide
• Slides: 1 Stained and 10 unstained
• Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 10 unstained, nonbaked slides wit 5-micron thick sections of the tumor tissue

Note: The total amount of required tumor nuclei can be obtained by scraping up to 10 slides from the same block

Additional Information: Unused unstained slides will not be returned

• Specimen Type: Cytology slide (direct smears or ThinPrep)
• Slides: 1 to 3 Slides
• Collection Instructions: Submit 1 to 3 slides stained and cover slipped with a preferred total of 5000 nucleated cells, or a minimum of at least 3000 nucleated cells

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times

Additional Information: Cytology slides will not be returned

MCLNR | MayoComplete Lung Rearrangements

This assay requires at least 10% tumor nuclei

• Preferred amount of tumor area with sufficient percent tumor nuclei: tissue 72 mm(2)
• Minimum amount of tumor area: tissue 18 mm(2)
• These amounts are cumulative over up to 10 unstained slides and must have adequate percent tumor nuclei
• Tissue fixation: 10% neutral buffered formalin, not decalcified

Preferred:

• Specimen Type: Tissue block and cell block
• Collection Instructions: Submit a formalin-fixed, paraffin-embedded tissue block or cell block with acceptable amount of tumor tissue

Acceptable

• Specimen Type: Tissue slides
• Slides: 1 Stained and 5 unstained
• Collection Instructions: Submit 1 slide stained with hematoxylin and eosin and 5 unstained, nonbaked slides wit 5-micron thick sections of the tumor tissue

Note: The total amount of required tumor nuclei can be obtained by scraping up to 5 slides from the same block

Additional Information: Unused unstained slides will not be returned

• Specimen Type: Cytology slides (direct smears)
• Slides: 1 to 3 Slides for smears
• Collection Instructions: Submit 1 to 3 slides unstained or stained with Diff Quik or Pap and cover slipped with a preferred total of 5000 nucleated cells or a minimum of at least 3000 nucleated cells

Note: Glass coverslips are preferred; plastic coverslips are acceptable but will result in longer turnaround times

Additional Information: Cytology slides used in testing will have everything scraped and not be returned

Performance information

MCLNG | MayoComplete Lung Cancer Panel and MCLNM | MayoComplete Lung Cancer Mutations

Analytic time: 12 days

Days performed: Monday through Friday

MCLNR | MayoComplete Lung Rearrangements

Analytic time: 4 days

Days performed: Varies

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