Alberta Precision Laboratories

--- Query Results ---

Organization:

Alberta Precision Laboratories

Message Alert:

PLEASE NOTE: This Test Directory is in an interim state and due to changes pertaining to the DynaLIFE transition, performing site for routing has not been updated. Please refer to Laboratory Information System for appropriate routing.

Test Name/Synonym:

Lung Carcinoma MassArray Early Stage (Synonyms: ALTER, EGFR, lung, lung adenocarcinoma and Lung Carcinoma Molecular Analysis DNA only [Hotspot EGFR/KRAS/ERBB2/BRAF/PIK3CA])

Clinical Indications:

Predictive biomarker testing in early stage lung adenocarcinoma.

Test Includes:

Molecular Pathology South:
DNA is extracted from formalin-fixed paraffin-embedded (FFPE) using the Promega Maxwell® RSC DNA FFPE Kit. Testing was performed using the Agena iPLEX HS Lung panel and analyzed using an Agena MassArray matrix assisted laser desorption-ionization time-of-flight mass spectrophotometer (MALDI-TOF MS).
This multiplex assay is capable of detecting BRAF mutations G469A, G459V, D594G, and V600E; EGFR point mutations at codons 709, 719, 768, 790, 797, 858, and 861, deletions in exon 19, and insertions in exon 20; ERBB2 insertion mutations at codons 775-776; KRAS mutations at codons 12, 13, and 61; and the PIK3CA mutations E542K, E545K, H1047R, and H1047L.

LABID (Connect Care):

LAB8033

Specimen Type:

Paraffin-Embedded Tissue

Specimen Source:

Indicate specimen source.

Specimen Collection Requirements:

For submissions to Molecular Pathology South

A formalin-fixed, paraffin-embedded tissue block (resection specimen, biopsy specimen, cytology cell block) accompanied by a representative H&E (ideally the deepest level) is preferred. The assay requires a minimum of 5% tumor in the selected area (5 tumor nuclei per 100 total nuclei). When possible, non-Cytolyt®-exposed FFPE tissue is preferred over Cytolyt®-exposed FFPE tissue (cytology cell blocks).
Alternatively, five 10-micron non-baked unstained slides accompanied by a representative H&E (ideally the deepest level) can be submitted. If the sample is relatively small (less than 10mm squared, for example a core biopsy 1mm in diameter and less than 1cm in length), particularly if the tissue has a low cell density, more than 5 (up to 10) 10-micron non-baked unstained slides may be sent to increase nucleic acid yield for testing.
Alternatively, precut scrolls can be submitted, accompanied by a representative H&E (ideally cut after the scrolls).
Note: The tissue should not be exposed to decalcification solution.

Test Resources:

Submit request using the applicable requisition or Connect Care online order entry:

Molecular Pathology South
	Molecular Pathology Requisition

Please ensure all required information, including patient's clinical history/indication, is provided on the requisition.

Stability and Storage:

Room temperature: paraffin-embedded tissue blocks and slides

Transportation:

Molecular Pathology South

Transport at room temperature to Pathology Department at Foothills Medical Center.

Method:

Molecular Pathology South
DNA testing: PCR followed by single base extension and mass spectrometry.

Method and Interpretation of Results:

Molecular Pathology South
DNA is extracted from formalin-fixed paraffin-embedded (FFPE) using the Promega Maxwell® RSC DNA FFPE Kit. Testing was performed using the Agena iPLEX HS Lung panel and analyzed using an Agena MassArray matrix assisted laser desorption-ionization time-of-flight mass spectrophotometer (MALDI-TOF MS).
This multiplex assay is capable of detecting BRAF mutations G469A, G459V, D594G, and V600E; EGFR point mutations at codons 709, 719, 768, 790, 797, 858, and 861, deletions in exon 19, and insertions in exon 20; ERBB2 insertion mutations at codons 775-776; KRAS mutations at codons 12, 13, and 61; and the PIK3CA mutations E542K, E545K, H1047R, and H1047L.

Variant nomenclature is provided with respect to the following reference transcripts: BRAF (NM_004333.6), EGFR (NM_005228.5), ERBB2 (NM_004448.4), KRAS (NM_033360.4), PIK3CA (NM_006218.4).

Test Limitation: For somatic variant detection, this assay has a lower limit of tumor cellularity of 5%. This assay only detects SNV and small insertions/deletions as specifically listed in the assay description (a "hotspot" panel).

Routine Turn Around Time:

10 business days

Testing Schedule:

Weekly

Testing Area:

Molecular Pathology

Performing Site:

Foothills Medical Center

Contact Comments:

Molecular Pathology South

403-220-4240.

Last Updated On:

Friday, October 27, 2023

Registered Trademark Comments:

CYTOLYT® is a trademark of Hologic, Inc.