Molecular Pathology Testing

Neisseria Gonorrhoeae (NG) and Chlamydia Trachomatis (CT) Testing

HPV Testing Methodology:Roche cobas® 4800 System Principle:The cobas HPV Test is an automated test run on the cobas® 4800 System which is used to identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. The test specifically identifies types HPV 16 and HPV 18 while concurrently detecting the rest of […]

HPV Testing and HPV Fax Back Order Form

HPV Fax Request Form HPV Testing Methodology:Roche cobas® 4800 System Principle:The cobas HPV Test is an automated test run on the cobas® 4800 System which is used to identify human papillomavirus (HPV) DNA from 14 high-risk genital HPV types that are commonly associated with cervical cancer. The test specifically identifies types HPV 16 and HPV 18 while concurrently

HER2 Gene Amplification FISH Assay

HER2 Gene Amplification Clinical Significance: Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend HER2 FISH testing as a reflex to further clarify equivocal (2+) immunohistochemistry (IHC) results and as routine testing in colorectal, gastroesophageal (GEJ),

Hematopathology FISH Panels

Hematopathology FISH Testing A comprehensive selection to enable the Hematopathologist to select the appropriate FISH and/or next-generation sequencing (NGS) Panel as needed for diagnosis – FISH Follow-up – FISH Panel will be selected based on previous abnormal – Individual Probes            ORSelect any panel or probe below: Multiple Myeloma (MM) Panel– May choose

Anal HPV Screening Protocol

Anal HPV Screening Protocol Principle:The “Anal Pap” is a screening tool used in at-risk populations to identify individuals who have premalignant cytologic changes in their anal epithelium. Procedure: Human Papilloma Virus (HPV) Testing may be ordered, in addition to routine cytology screening. However, HPV Testing on anal samples has not been validated or FDA approved.

Lung Carcinoma Molecular Analysis

Lung Carcinoma Molecular Analysis Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a

FISH for ROS1 Gene Rearrangements

ROS1 (6q22) Gene Rearrangement Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a primary

FISH for RET Gene Rearrangements

RET (10q11) Gene Rearrangement Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a primary

FISH for MET Gene Amplification

MET (7q31) exon 14 skipping and gene amplification Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have

FISH for ALK Gene Rearrangements

ALK (2p23) Gene Rearrangement Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a primary

ERBB2 (HER2) Gene Mutation (Exon20) Detection

ERBB2 (HER2)Gene Mutation (Exon 20) Detection Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had

Epidermal Growth Factor Receptor (EGFR) Mutation Analysis

Epidermal Growth Factor Receptor (EGFR) Mutation Analysis Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have

BRAF Mutation Assay

BRAF V600E Mutation Detection Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend testing for all newly diagnosed non-small cell, non-squamous lung carcinomas or such metastatic lung carcinomas that have not had a primary

NRAS Mutation Assay

NRAS Mutation Detection Clinical Significance:The American Society of Clinical Oncologists (ASCO), ASCP, CAP, AMP, and National Comprehensive Cancer Network (NCCN) recommend routine testing for RAS mutation at diagnosis of stage IV disease and all colorectal carcinomas considered for therapy with cetuximab or panitumumab, either alone or in combination with other anti-cancer agents. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Specimen Requirements and Collection:Formalin fixed

Microsatellite Instability (MSI)

Microsatellite Instability (MSI) Analysis Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP) and/or the American Society of Clinical Oncology (ASCP) recommend microsatellite Instability (MSI) testing for all newly diagnosed patients with colon cancer. MSI-H tumors are reflexed to MMR IHC testing and BRAF V600 mutation,

KRAS Mutation Assay

KRAS Mutation Detection Clinical Significance:The American Society of Clinical Oncologists (ASCO), ASCP, CAP, AMP, and National Comprehensive Cancer Network (NCCN) recommend routine testing for RAS mutation at diagnosis of stage IV disease and all colorectal carcinomas considered for therapy with cetuximab or panitumumab, either alone or in combination with other anti-cancer agents. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Specimen Requirements and Collection:Formalin fixed

HER2 Gene Amplification

HER2 Gene Amplification Clinical Significance: The American Society of Clinical Oncologists (ASCO), ASCP, CAP, AMP, and National Comprehensive Cancer Network (NCCN) recommend HER2 gene amplification status determination on colorectal cancer patients inappropriate for intensive systemic therapy in a setting of advanced or metastatic disease. Anti-HER2 therapy is only indicated for HER2-amplified tumors that are also RAS and BRAF wild-type. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Specimen Requirements and Collection:This

Colorectal Carcinoma Molecular Analysis

Colorectal Carcinoma Molecular Analysis Clinical Significance:Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP) and/or the American Society of Clinical Oncology (ASCP) recommend testing for all resected colorectal carcinomas or metastatic colorectal carcinomas and selected biopsy cases where resection will not be performed

BRAF Mutation Assay

BRAF V600 Mutation Detection Clinical Significance:BRAF V600 mutation analysis is useful in determining patient eligibility for targeted EGFR inhibitor therapy for metastatic colorectal carcinoma and for Lynch syndrome reflex testing (in colorectal carcinomas). https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Specimen Requirements and Collection:Formalin fixed tissue containing a sufficient amount of tumor (generally at least several mm of tumor tissue submitted in

HER2 Gene Amplification

HER2 Gene Amplification Clinical Significance: Recently established guidelines from the American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and/or the American Society of Clinical Oncology (ASCP) recommend HER2 testing in invasive breast cancer patients. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf Specimen Requirements and Collection:Formalin fixed tissue containing a sufficient amount of tumor (generally at