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Molecular

Precision Medicine - Next Generation Sequencing

Comprehensive solid tumor gene panel

This is a targeted, next-generation sequencing (NGS) assay that provides a comprehensive genomic profiling solution appropriate for FFPE tissues. The assay addresses multiple biomarkers for targeted and immune checkpoint therapies, covering over 500 genes, including comprehensive targets that are relevant in cancer. This assay allows concurrent analysis of DNA and RNA to simultaneously detect multiple types of variants, including hotspots, single nucleotide variants (SNVs), insertions and deletions (INDELs), copy number variants (CNVs), microsatellite instability (MSI), tumor mutational burden (TMB), and gene fusions. The panel can be ordered on any solid tumor FFPE blocks excluding sarcomas and uveal melanoma. This panel can also be ordered on cytology cell blocks.

Myeloid panel

Myeloid Assay is a targeted, multi-biomarker assay designed to target hotspots (SNVs, MNVs and indels), gene expression and gene fusions from DNA and RNA in a single workflow. This panel is comprised of 40 key DNA genes and a broad fusion panel of 29 driver genes to cover the most relevant targets in major myeloid disorders: acute myeloid leukemia (AML), myeloid dysplastic syndrome (MDS), myeloproliferative neoplasms (MPN), chronic myeloid leukemia (CML), chronic myelomonocytic leukemia (CMML), and juvenile myelomonocytic leukemia (JMML), and is compatible with blood and bone marrow samples.

Advanced NGS panels

Alverno Laboratories’ partnership with Genomics Testing Cooperative (GTC) provides oncology patients with more complex cases access to GTC’s advanced offerings. We are pleased to offer multiple tests including GTC- Solid Tumor Profile Plus (434 DNA genes and 1408 RNA genes) and Hematology Profile Plus (179 DNA genes and 1408 RNA genes). Our partnership also brings forth access to the giant leap in liquid biopsy technology, Liquid Trace™. GTC’s Liquid Trace is a pan-cancer test evaluating 284 cfDNA genes and 1501 cfRNA providing highly informative data that can be used for diagnoses, evaluating the host immune response, and identifying biomarkers for predicting responses to various therapies.

Real-time PCR

Microsatellite Instability (MSI)

MSI Assay is intended for the qualitative detection of a novel panel of seven monomorphic biomarkers (ACVR2A, BTBD7, DIDO1, MRE11, RYR3, SEC31A and SULF2) for identification of human cancers with MSI. High levels of MSI are indicative of defective DNA mismatch repair. A dMMR system is a common cause of cancer, contributing to tumor growth and evolution. Determining MSI status greatly aids tumor prognosis and treatment plans in colorectal cancer. MSI detection is also useful to identify patients with Lynch Syndrome. The recent NCCN guidelines recommend universal screening for Lynch syndrome in all diagnosed colorectal and endometrial carcinomas through immunohistochemical evaluation of mismatch repair protein expression and/or microsatellite instability evaluation. The evaluation of both dMMR and MSI improves sensitivity in the screening of Lynch syndrome. Clinical specimen: 2-4  FF Paraffin Embedded Tumor Tissue slides.

EGFR

EGFR Mutation Assay detects exon 18 (G719A/C/S), exon 20 (T790M, S768I), exon 21 (L858R, L861Q) mutations, exon 19 deletions and exon 20 insertions of the EGFR gene in FFPE tissues. EGFR assay is indicated for identifying non-small cell lung cancers that may respond to epidermal growth factor receptor tyrosine kinase inhibitor therapy. specimen: 2-4  FF Paraffin Embedded Tumor Tissue slides.

KRAS

KRAS Mutation Assay detects mutations in exons 2, 3, and 4 of the KRAS oncogene. The Assay consists of five allele-specific multiplex PCR reactions, designed to specifically amplify KRAS gene sequences with a mutation in codon 12, 13, 59, 61, 117 or 146. Aids in treatment decisions in individuals with solid tumors including colorectal and non-small cell lung cancers. Alterations in the KRAS gene may indicate a poor response to EGFR-targeted therapies including Cetuximab and Pantimumumab.  Clinical specimen: 2-4  FF Paraffin Embedded Tumor Tissue slides.

BRAF

BRAF Mutation Assay detects V600E/D and V600K/R/M mutations in codon 600 of the BRAF gene. Melanomas with codon 600 BRAF mutations are associated with response to the BRAF-directed kinase inhibitor vemurafenib (ZELBORAF®). Clinical specimen: 2-4  FF Paraffin Embedded Tumor Tissue slides.

Factor V and Factor II

Detection of the Factor V Leiden mutation and Factor II prothrombin mutation by PCR. The Factor V and Factor II test aids in the identification of genetic mutations which can cause thrombotic events such blood clots. EDTA or Citrate Anti-coagulated Peripheral Blood tubes are accepted. Clinical specimen: EDTA or Citrate Anti-coagulated Peripheral Blood.

Flow Cytometry

CD4/CD8 (T-Cell Subsets)

Establishes total Tcell (CD3), Tcell helper (CD4), and Tcell suppressor (CD8)   percentages and absolute counts by Flow Cytometry. This test aids in the evaluation of a patients immune competency by measuring  lymphocyte levels. It is typically used to help monitor patients with underlying conditions which effect their immunity such as HIV or organ transplantation. Clinical specimen: EDTA whole blood.

TBNK (Lymphocyte Subsets)

Establishes total Tcell (CD3), total B cell (CD19), and total natural killer cell (CD56)   percentages and absolute counts by Flow Cytometry. This test aids in the evaluation of a patients immune competency by measuring lymphocyte levels. It is typically used to help monitor patients with underlying conditions which effect their immunity such as HIV or organ transplantation. Clinical specimen: EDTA whole blood.

Lymphoma/Leukemia Immunophenotyping

This test allows for identification of abnormal hematological cells which can aid in the diagnosis and detection of a hematological abnormalities. Lymphoma/Leukemia immunophenotyping can be useful in detecting acute leukemia, B-cell lymphoproliferate disorders, T-cell lymphoproliferative disorders, natural killer cell lymphoproliferate disorders, MDS, and plasma cell proliferative disorders. Clinical specimen: EDTA or Heparin Whole blood, EDTA or Heparin Bone Marrow, Aspirate Tissue biopsies in RPMI, Body Fluids, Fine Needle Aspirates (FNA).

Immunodeficiency Panel

Establishes total Tcell (CD3), Tcell helper (CD4), and Tcell suppressor (CD8), total B cell (CD19), and total natural killer cell (CD56), and absolute lymphocyte   percentages and absolute counts by Flow Cytometry. This test aids in the evaluation of a patient's immune competency by measuring lymphocyte levels. It is typically used to help monitor patients with underlying conditions which effect their immunity such as HIV or organ transplantation. Clinical specimen: EDTA whole blood.

Fetal Bleed

Detection and assessment of fetal-maternal hemorrhage by Flow cytometry. This test detects and measures the amount of HbF positive fetal cells present in the mothers blood. The Flow fetal hemorrhage screen can determine the amount of Rh immune globulin dosage needed by the mother and help to evaluate the possible trauma to fetus. Clinical specimen: EDTA whole blood.

HLA B27

Detection of HLA-B27 antigen by Flow Cytometry assists in the diagnosis of ankylosing spondylitis, juvenile rheumatoid arthritis, and Reiter's syndrome. Approximately 8% of the normal population carries the HLA-B27 antigen. This antigen is present in ~89% of patients with ankylosing spondylitis. However, lacking other data, it is not diagnostic for these disorders. Clinical specimen: EDTA whole blood.

 

FISH

Solid Tumors

  • HER2 Expression

Detection of HER2 gene over expression in breast, endometrial and gastric cancer by FISH. HER2 Fish is designed to evaluate cancer biopsies for the over expression of HER2. HER2 positive breast cancer may benefit from Herceptin treatment. Clinical specimen: 2 FFPE Breast, endometrial or Gastric Cancer Tissue slides and 1 H&E slide.

  • ALK Rearrangement

Patients that exhibit ALK re-arrangements are resistant to EGFR tyrosine kinase inhibitors but may be sensitive to ALK inhibitors.  ALK by FISH is indicated for the identification of lung cancer patients who may benefit from ALK inhibitor therapy. Clinical specimen: 2 FFPE Lung cancer tissue slides and 1 H&E slide.

  • ROS1 Rearrangement

Patients that exhibit ROS1 re-arrangements are resistant to EGFR tyrosine kinase inhibitors but may be sensitive to ALK inhibitors.  ROS1 by FISH is indicated for the identification of lung cancer patients who may benefit from ALK inhibitor therapy. Clinical specimen: 2 FFPE Lung cancer tissue slides and 1 H&E slide.

Hematological malignancies

  • Chronic Lymphocytic Leukemia (CLL)

Detection of the most common CLL genetic mutations (P53, ATM, D13S319, 13q34, and CEP12) by FISH (fluorescence in situ hybridization) as well as t(11;14). The FISH CLL panel provides typing of the mutation if present and can aid the physician in determining the prognosis of the CLL patient or diagnosis of mantle cell lymphoma. Clinical specimen: 2ml of Sodium Heparin Bone Marrow or Sodium Heparin Whole Blood.

  • Myelodysplastic Syndrome (MDS)

Detection of genetic mutations in chromosomes 5, 7, 8, and 20. This panel can help classify MDS diagnosis and provides significant prognostic information. Clinical specimen: 2ml of Sodium Heparin Bone Marrow or Sodium Heparin Whole Blood.

  • BCR/ABL Translocation

Aids in the diagnosis of Chronic Myelogenous Leukemia (CML) and monitoring the effectiveness of therapy. Clinical specimen: 2ml of Sodium Heparin Bone Marrow or Sodium Heparin Whole Blood.

  • Non-Hodgkins Lymphoma (NHL)

Aids in the diagnosis and classification of B-cell lymphoma and monitoring the response to therapy or progression of disease. Clinical specimen: 2ml of Sodium Heparin Bone Marrow or Sodium Heparin Whole Blood.

  • Multiple Myeloma/MGUS

Aids in the diagnosis of new cases of multiple myeloma and yields significant prognostic information for risk assessment and treatment stratification based on the anomalies found. Clinical specimen: 2ml of Sodium Heparin Bone Marrow or Sodium Heparin Whole Blood.

  • Acute Myeloid Leukemia (AML)

Aids in the diagnosis of new cases of AML and yields significant prognostic information for risk assessment and treatment stratification based on the anomalies found. Clinical specimen: 2ml of Sodium Heparin Bone Marrow or Sodium Heparin Whole Blood.

Molecular Microbiology

Virus

Respiratory Pathogen Panel, Norovirus, CMV Qualitative PCR, HSV(Herpes)Typing by PCR, VZV(Varicella) by PCR.

Bacteria

MRSA/SA Surgical Screen, MRSA/SA Blood, Carba-R, Group B Strep, C.diff, Bacterial Enteric Panel Basic, Bacterial Enteric Extended Panel, Bordetella Pertussis/Parapertussis, Vaginitis Panel, Mycoplasma pneumoniae.

Parasite

Enteric Parasite Panel