Testing
The AML gene analysis is a qualitative diagnostic test containing a subset of genes (ASXL1, DNMT3A, IDH1, IDH2, KIT, NPM1, RUNX1, TET2, TP53, WT1) combined with send out testing for…
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M KRAS
Utilized as an independent predictor of colorectal cancer (CRC) and patient responsiveness to EGFR (TKI) inhibitor therapy. KRAS Mutation Analysis
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Evaluation for suspected clonal B-cell lymphoproliferations when morphologic, immunochemical, and/or flow cytometry analyses are inconclusive. Molecular IgK testing is a useful complement to IgH analysis for confirmation of clonality in…
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Molecular characterization of T-cell receptor gene rearrangements and immunoglobulin heavy and light chain gene rearrangement detection is accomplished with reliable and robust tests to identify clonal T-cell and B-cell populations…
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Evaluation for suspected clonal B-cell lymphoproliferations when morphologic, immunochemical and/or flow cytometry analyses are inconclusive.
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Utilized for the determination of baseline PML/RARA fusion gene transcript levels and monitoring of same for molecular evidence of minimal residual disease (MRD) or molecular remission in patients with AML-M3…
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M FLT3*
Intended for use as a screening test in patients with AML to assist with stratification and selection of post-remission therapies. Internal tandem duplications in exons 14 and 15 of the… FLT3 Mutation Analysis
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Somatic mutations of codons 515 and 505 in exon 10 of the “myeloproliferative leukemia virus oncogene” (MPL) represent clonal markers in essential thrombocythemia (ET) and primary myelofibrosis (PMF). MPL codon…
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CLL/SLL is the most common leukemia diagnosed among adults in Western countries and is associated with heterogeneous clinical outcomes. IgVH somatic hypermutation (SHM) status is a primary component of the…
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M CEBPA*
Mutations in CEBPA are found in 15-18% of cases of cytogenetically normal AML and are associated with a favorable prognosis. Germline mutations in CEBPA are a cause of nonsyndromic, familial… CEBPA Mutation Analysis
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M BCR ABL
Molecular detection of the BCR/ABL fusion gene transcript (e13a2, e14a2, e1a2) in patients with a Philadelphia (t[(9;22)(q34;q11.2)]) positive leukemia. The translocation is found in >99% of CML patients, ~20% of… BCR/ABL1 qRT PCR
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Intended for use as a screening test for evidence of Chlamydia trachomatis infection.
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Used to screen women with ASC-US cervical cytology results to determine the need for referral to colposcopy. To be used adjunctively with cervical cytology to screen women 30 years of…
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Utilized as an independent predictor of colorectal cancer (CRC) patient responsiveness to EGFR inhibitor therapy and to assist with the differentiation of microsatellite instability high (MSI-H) hereditary non-polyposis colon cancer…
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CALR somatic mutations are seen in a subset of patients with MPNs who lack JAK2 and MPL mutations. CALR mutations appear restricted to patients with ET and PMF and are…
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MolecularMD has designed and validated bi-directional Sanger sequencing assays to identify mutations in the p210 and p190 transcripts of the BCR-ABL1 fusion gene. Our assay spans an extended region including…
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Intended for use to assist in the confirmation of a diagnosis of a HSV-1 and/or HSV-2 infection.
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Intended for use to assist in the confirmation of a diagnosis of a HSV-1 and/or HSV-2 infection.
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The Luminex xTAG® Cystic Fibrosis (CFTR) 39 kit v2 (IVD) allows for the detection and simultaneous identification of a panel of 39 mutations and 4 variants in the cystic fibrosis…
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M EGFR
This sequencing panel is useful in determining eligibility for tyrosine kinase inhibitor (TKI) therapy in patients with non-small cell lung cancer (NSCLC). The EGFR mutation is present in 10-15% of… EGFR Mutation Analysis
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M MYD88
MYD88 L265P mutations are present in the majority of LPL cases include Waldenström’s macroglobulinemia, Mutations are also detected in a low percentage of chronic lymphocytic leukemia (CLL) and diffuse large… MYD88 p. L265P Mutation
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The APTIMA Trichomonas vaginalis Assay is an in vitro qualitative nucleic acid amplification test cleared by the FDA for the detection of ribosomal RNA (rRNA) from Trichomonas vaginalis to aid…
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Evaluation of patients with a high index of clinical suspicion for a Philadelphia chromosome-negative (BCR/ABL negative) myeloproliferative disorder (polycythemia vera, essential thrombocythemia, idiopathic myelofibrosis)
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M CF NGS Seq
CF diagnosis and carrier status Cystic Fibrosis MiSeqDx Clinical Sequence Assay
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M KIT AML
Associated with less favorable outcome. TKIs may be useful in conjunction with standard chemotherapy KIT Mutations in AML by NGS
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MGMT Methylation Detection by PCR - send out
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Aids in the diagnosis of mastocytosis. Provide prognostic and predictive information for tyrosine kinase inhibitor (TKI) therapy planning.
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M LUNG NGS
This sequencing panel is useful in determining eligibility for tyrosine kinase inhibitor (TKI) therapy in patients with non-small cell lung cancer (NSCLC). The EGFR mutation is present in 10-15% of… Lung Cancer NGS
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To be used adjunctively, with an FDA approved HPV high risk test, in patients with either a HPV HR+ ASC-US result or, in women 30 years of age and older,…
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Intended for use as a screening test for evidence of Neisseria gonorrhoeae infection.
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Cystic Fribrosis(Amniotic fluid) 32 Mutation Analysis Prenatal Panel
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Intended for use to assist in the confirmation of a diagnosis of a HSV-1 and/or HSV-2 infection.
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M IDH1/2
Targeted next generation sequencing is performed to asses for the following pathogenic hotspot mutations: IDH1 p.R132 and IDH2 p.R140 and IDH2p.R172. IDH1 and IDH2 Mutation Analysis
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Glioma multidisciplinary testing panel
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M IDH2
Targeted next generation sequencing is performed to asses for the following pathogenic hotspot mutations: IDH2 p.R140 and IDH2p.R172. IDH2 Mutation Analysis
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M IDH1
Targeted next generation sequencing is performed to asses for the following pathogenic hotspot mutations: IDH1 p.R132 IDH1 Mutation Analysis
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M ST NGS GIST
Detects activating mutations in KIT and PDGFRA. Predicts response to tyrosine kinase inhibitor (TKI) therapy. Solid Tumor – GIST
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exon9/11, exon 13/17, exon 12/18 reflex combo
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