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 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 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 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 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
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
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
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
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 (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 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 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 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) 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 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 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 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 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 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
Special Stains Alcian Blue/pH 2.5: stains both sulfated and carboxylated acid mucopolysaccharides and sulfated and carboxylated sialomucins (glycoproteins). Alcian Blue/PAS: Acidic mucosubstances are stained with the alcian blue technique and neutral mucosubstances are stained by the PAS reaction. AFB (Ziehl-Neelsen): for the demonstration of acid-fast organisms. Argentaffin Granules, Fontana-Masson: for the demonstration of argentaffin substances such as melanin, argentaffin
Panels, Double, and Triple Stains PANELSLung Panel (P40, TTF1 – Napsin A): Used to differentiate between lung adenocarcinoma and squamous cell carcinoma of the lung. DOUBLE STAINSPan Keratin – p63: For evaluation of microinvasion in small breast biopsies Cytokeratin 34β12 (K903) – Racemase (p504s): For evaluation of small foci of invasive prostate carcinoma P40 – Cytokeratin 5/6: For evaluation
In-Situ Hybridization Testing EBV-ISH: is used for the detection of early RNA transcript of Epstein-Barr Virus (EBV) infection. Kappa-ISH: is intended to detect cytoplasmic mRNA for Kappa immunoglobulins light chain in tissue. Combined with Inform Cytoplasmic mRNA Probe for Lambda, the assays assist distinction between polyclonal and monoclonal proliferations of plasma or B cells. Lambda-ISH: is intended to
Immunohistochemistry Testing AFP: has been immunohistochemically demonstrated in yolk sac carcinomas of gonadal and extragonadal site, in hepatic malignancies and a few other neoplasms. ALK-1: labels normal human ALK protein and the NPM-ALK chimeric protein, and it is a useful tool for the identification of the subgroup of anaplastic large-cell lymphomas (ALCL) that are ALK positive. Arginase-1:
