| PLA Code |
Description |
Test Name |
Lab Name |
Manufacturer |
Effective Date |
|
0001U
|
Red blood cell antigen typing, DNA, human erythrocyte antigen gene analysis of 35 antigens from 11 blood groups, utilizing whole blood, common RBC alleles reported
|
PreciseType® HEA Test
|
|
Immucor, Inc
|
11/30/2016
|
|
0002U
|
Oncology (colorectal), quantitative assessment of three urine metabolites (ascorbic acid, succinic acid and carnitine) by liquid chromatography with tandem mass spectrometry (LC-MS/MS) using multiple reaction monitoring acquisition, algorithm reported as likelihood of adenomatous polyps
|
PolypDX™
|
Atlantic Diagnostic Laboratories, LLC
|
Metabolomic Technologies Inc
|
11/30/2016
|
|
0003U
|
Onocology (ovarian) biochemical assays of five proteins (apolipoprotein A-1, CA 125 II, follicle stimulating hormone, human epididymis protein 4, transferrin), utilizing serum, algorithm reported as a likelihood score
|
Overa (OVA1 Next Generation)
|
Aspira Labs, Inc
|
Vermillion, Inc
|
11/30/2016
|
|
0005U
|
Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score
|
ExosomeDx® Prostate(IntelliScore)
|
Exosome Diagnostics, Inc
|
Exosome Diagnostics, Inc
|
11/30/2016
|
|
0006U
|
Detection of interacting medications, substances, supplements and foods, 120 or more analytes, definitive chromatography with mass spectrometry, urine, description and severity of each interaction identified, per date of service
|
Drug-drug, Drug-substance Identification and Interaction
|
Aegis Sciences Corporation
|
Drug-drug, Drug-substance Identification and Interaction
|
11/30/2017
|
|
0007U
|
Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, includes specimen verification including DNA authentication in comparison to buccal DNA, per date of service
|
ToxProtect
|
Genotox Laboratories LTD
|
Genotox Laboratories LTD
|
11/30/2016
|
|
0008U
|
Helicobacter pylori detection and antibiotic resistance, DNA, 16S and 23S rRNA, gyrA, pbp1, rdxA and rpoB, next generation sequencing, formalin-fixed paraffin-embedded or fresh tissue or fecal sample, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline, and rifabutin
|
AmHPR H. Antibiotic Resistance Next Generation Sequencing Panel
|
American Molecuclar Laboratories, Inc
|
American Molecuclar Laboratories, Inc
|
11/30/2018
|
|
0009U
|
Oncology (breast cancer), ERBB2 (HER2) copy number by FISH, tumor cells from formalin-fixed paraffin-embedded tissue isolated using image-based dielectrophoresis (DEP) sorting, reported as ERBB2 gene amplified or non-amplified
|
DEPArray™ HER2
|
PacificDx
|
PacificDx
|
11/30/2016
|
|
0010U
|
Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate
|
Bacterial Strain Typing by Whole Genome Sequencing
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
0011U
|
Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, using oral fluid, reported as a comparison to an estimated steady-state range, per date of service including all drug compounds and metabolites
|
Cordant CORE™
|
Cordant Health Solutions
|
Cordant Health Solutions
|
11/30/2016
|
|
0012U
|
Germline disorders, gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood, report of specific gene rearrangement(s)
|
MatePair Targeted Rearrangements, Congenital
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
0013U
|
Oncology (solid organ neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, fresh or frozen tissue or cells, report of specific gene rearrangement(s)
|
MatePair Targeted Rearrangements, Oncology
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
0014U
|
Hematology (hematolymphoid neoplasia), gene rearrangement detection by whole genome next-generation sequencing, DNA, whole blood or bone marrow, report of specific gene rearrangement(s)
|
MatePair Targeted Rearrangements, Hematologic
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
0016U
|
Oncology (hematolymphoid neoplasia), RNA, BCR/ABL1 major and minor breakpoint fusion transcripts, quantitative PCR amplification, blood or bone marrow, report of fusion not detected or detected with quantitation
|
BCR-ABL1 major and minor breakpoint fusion transcripts
|
University of Iowa, Department of Pathology
|
Asuragen
|
11/30/2016
|
|
0017U
|
Oncology (hematolymphoid neoplasia), JAK2 mutation, DNA, PCR amplification of exons 12-14 and sequence analysis, blood or bone marrow, report of JAK2 mutation not detected or detected
|
JAK2 Mutation
|
University of Iowa, Department of Pathology
|
University of Iowa, Department of Pathology
|
11/30/2016
|
|
0018U
|
Oncology (thyroid), microRNA profiling by RT-PCR of 10 microRNA sequences, utilizing fine needle aspirate, algorithm reported as a positive or negative result for moderate to high risk of malignancy
|
ThyraMIR
|
Interpace Diagnostics
|
Interpace Diagnostics
|
11/30/2016
|
|
0019U
|
Oncology, RNA, gene expression by whole transcriptome sequencing, formalin-fixed paraffin-embedded tissue or fresh frozen tissue, predictive algorithm reported as potential targets for therapeutic agents
|
OncoTarget/OncoTreat
|
Columbia University Department of Pathology and Cell Biology
|
Darwin Health
|
11/30/2016
|
|
0021U
|
Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5’-UTR-BMI1, CEP 164, 3’-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score
|
Apifiny®
|
Armune BioScience
|
Armune BioScience Inc
|
11/30/2016
|
|
0022U
|
Targeted genomic sequence analysis panel, non-small cell lung neoplasia, DNA and RNA analysis, 23 genes, interrogation for sequence variants and rearrangements, reported as presence/absence of variants and associated therapy(ies) to consider
|
Oncomine™ Dx Target Test
|
Thermo Fisher Scientific
|
Thermo Fisher Scientific
|
11/30/2016
|
|
0023U
|
Oncology (acute myelogenous leukemia), DNA, genotyping of internal tandem duplication, p.D835, p.I836, using mononuclear cells, reported as detection or non-detection of FLT3 mutation and indication for or against the use of midostaurin
|
LeukoStrat® CDx FLT3 Mutation Assay
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
Invivoscribe Technologies, Inc
|
11/30/2016
|
|
0024U
|
Glycosylated acute phase proteins (GlycA), nuclear magnetic resonance spectroscopy, quantitative
|
GlycA
|
Laboratory Corporation of America
|
Laboratory Corporation of America
|
11/30/2017
|
|
0025U
|
Tenofovir, by liquid chromatography with tandem mass spectrometry (LC-MS/MS), urine, quantitative
|
UrSure Tenofovir Quantification Test
|
Synergy Medical Laboratories
|
UrSure Inc
|
11/30/2017
|
|
0026U
|
Oncology (thyroid), DNA and mRNA of 112 genes, next-generation sequencing, fine needle aspirate of thyroid nodule, algorithmic analysis reported as a categorical result ("Positive, high probability of malignancy" or "Negative, low probability of malignancy")
|
Thyroseq Genomic Classifier
|
CBLPath, Inc
|
University of Pittsburgh Medical Center
|
11/30/2017
|
|
0027U
|
JAK2 (Janus kinase 2) (eg, myeloproliferative disorder) gene analysis, targeted sequence analysis exons 12-15
|
JAK2 Exons 12 to 15 Sequencing
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0029U
|
Drug metabolism (adverse drug reactions and drug response), targeted sequence analysis (ie, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 and rs12777823)
|
Focused Pharmacogenomics Panel
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0030U
|
Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823)
|
Warfarin Response Genotype
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0031U
|
CYP1A2 (cytochrome P450 family 1, subfamily A, member 2) (eg, drug metabolism) gene analysis, common variants (ie, *1F, *1K, *6, *7)
|
Cytochrome P450 1A2 Genotype
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0032U
|
COMT (catechol-O-methyltransferase) (eg, drug metabolism) gene analysis, c.472G>A (rs4680) variant
|
Catechol-O-Methyltransferase (COMT) Genotype
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0033U
|
HTR2A (5-hydroxytryptamine receptor 2A), HTR2C (5-hydroxytryptamine receptor 2C) (eg, citalopram metabolism) gene analysis, common variants (ie, HTR2A rs7997012 [c.614-2211T>C], HTR2C rs3813929 [c.-759C>T] and rs1414334 [c.551-3008C>G])
|
Serotonin Receptor Genotype (HTR2A and HTR2C)
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0034U
|
TPMT (thiopurine S-methyltransferase), NUDT15 (nudix hydroxylase 15) (eg, thiopurine metabolism) gene analysis, common variants (ie, TPMT *2, *3A, *3B, *3C, *4, *5, *6, *8, *12; NUDT15 *3, *4, *5)
|
Thiopurine Methyltransferase (TPMT) and Nudix Hydrolase (NUDT15) Genotyping
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
0035U
|
Neurology (prion disease), cerebrospinal fluid, detection of prion protein by quaking-induced conformational conversion, qualitative
|
Real-time quaking-induced conversion for prion detection (RT-QuIC)
|
National Prion Disease Pathology Surveillance Center
|
|
11/30/2017
|
|
0036U
|
Exome (ie, somatic mutations), paired formalin-fixed paraffin-embedded tumor tissue and normal specimen, sequence analyses
|
EXaCT-1 Whole Exome Testing
|
Lab of Oncology-Molecular Detection
|
Weill Cornell Medicine-Clinical Genomics Laboratory
|
11/30/2017
|
|
0037U
|
Targeted genomic sequence analysis, solid organ neoplasm, DNA analysis of 324 genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability and tumor mutational burden
|
FoundationOne CDx™ (F1CDx)
|
Foundation Medicine, Inc
|
Foundation Medicine, Inc
|
11/30/2017
|
|
0038U
|
Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative
|
Sensieva™ Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay
|
InSource Diagnostics
|
|
11/30/2017
|
|
0039U
|
Deoxyribonucleic acid (DNA) antibody, double stranded, high avidity
|
Anti-dsDNA, High Salt/Avidity
|
University of Washington, Department of Laboratory Medicine
|
Bio-Rad
|
11/30/2017
|
|
0040U
|
BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative
|
MRDx BCR-ABL Test
|
MolecularMD
|
MolecularMD
|
11/30/2017
|
|
0041U
|
Borrelia burgdorferi, antibody detection of 5 recombinant protein groups, by immunoblot, IgM
|
Lyme ImmunoBlot IgM
|
IGeneX Inc
|
ID-FISH Technology Inc (ASR) (Lyme ImmunoBlot IgM Strips Only)
|
11/30/2017
|
|
0042U
|
Borrelia burgdorferi, antibody detection of 12 recombinant protein groups, by immunoblot, IgG
|
Lyme ImmunoBlots IgG
|
IGeneX Inc
|
ID-FISH Technology Inc (ASR) (Lyme ImmunoBlot IgG Strips Only)
|
11/30/2017
|
|
0043U
|
Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgM
|
Tick-Borne Relapsing Fever Borrelia (TBRF) ImmunoBlots IgM Test
|
IGeneX Inc
|
ID-FISH Technology Inc (Provides TBRF ImmunoBlot IgM Strips)
|
11/30/2017
|
|
0044U
|
Tick-borne relapsing fever Borrelia group, antibody detection to 4 recombinant protein groups, by immunoblot, IgG
|
Tick-Borne Relapsing Fever Borrelia (TBRF) ImmunoBlots IgG Test
|
IGeneX Inc
|
ID-FISH Technology Inc (Provides TBRF ImmunoBlot IgG Strips)
|
11/30/2017
|
|
0045U
|
Oncology (breast ductal carcinoma in situ), mRNA, gene expression profiling by real-time RT-PCR of 12 genes (7 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as recurrence score
|
The Oncotype DX® Breast DCIS Score™ Test
|
Genomic Health, Inc
|
Genomic Health, Inc
|
11/30/2017
|
|
0046U
|
FLT3 (fms-related tyrosine kinase 3) (eg, acute myeloid leukemia) internal tandem duplication (ITD) variants, quantitative
|
FLT3 ITD MRD by NGS
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
11/30/2017
|
|
0047U
|
Oncology (prostate), mRNA, gene expression profiling by real-time RT-PCR of 17 genes (12 content and 5 housekeeping), utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a risk score
|
Oncotype DX Genomic Prostate Score
|
Genomic Health, Inc
|
Genomic Health, Inc
|
11/30/2017
|
|
0048U
|
Oncology (solid organ neoplasia), DNA, targeted sequencing of protein-coding exons of 468 cancer-associated genes, including interrogation for somatic mutations and microsatellite instability, matched with normal specimens, utilizing formalin-fixed paraffin-embedded tumor tissue, report of clinically significant mutation(s)
|
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets)
|
Memorial Sloan Kettering Cancer Center
|
Memorial Sloan Kettering Cancer Center
|
11/30/2017
|
|
0049U
|
NPM1 (nucleophosmin) (eg, acute myeloid leukemia) gene analysis, quantitative
|
NPM1 MRD by NGS
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
11/30/2017
|
|
0050U
|
Targeted genomic sequence analysis panel, acute myelogenous leukemia, DNA analysis, 194 genes, interrogation for sequence variants, copy number variants or rearrangements
|
MyAML NGS Panel
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
11/30/2017
|
|
0051U
|
Prescription drug monitoring, evaluation of drugs present by LC-MS/MS, urine, 31 drug panel, reported as quantitative results, detected or not detected, per date of service
|
UCompliDx
|
Elite Medical Laboratory Solutions, LLC (LDT)
|
Elite Medical Laboratory Solutions, LLC
|
11/30/2017
|
|
0052U
|
Lipoprotein, blood, high resolution fractionation and quantitation of lipoproteins, including all five major lipoprotein classes and subclasses of HDL, LDL, and VLDL by vertical auto profile ultracentrifugation
|
VAP Cholesterol Test
|
VAP Diagnostics Laboratory, Inc
|
VAP Diagnostics Laboratory, Inc
|
11/30/2017
|
|
0053U
|
Oncology (prostate cancer), FISH analysis of 4 genes (ASAP1, HDAC9, CHD1 and PTEN), needle biopsy specimen, algorithm reported as probability of higher tumor grade
|
Prostate Cancer Risk Panel
|
Mayo Clinic, Laboratory Developed Test
|
Mayo Clinic
|
11/30/2017
|
|
0054U
|
Prescription drug monitoring, 14 or more classes of drugs and substances, definitive tandem mass spectrometry with chromatography, capillary blood, quantitative report with therapeutic and toxic ranges, including steady-state range for the prescribed dose when detected, per date of service
|
AssuranceRx Micro Serum
|
Firstox Laboratories, LLC
|
Firstox Laboratories, LLC
|
11/30/2017
|
|
0055U
|
Cardiology (heart transplant), cell-free DNA, PCR assay of 96 DNA target sequences (94 single nucleotide polymorphism targets and two control targets), plasma
|
myTAIHEART
|
TAI Diagnostics, Inc
|
TAI Diagnostics, Inc
|
11/30/2017
|
|
0056U
|
Hematology (acute myelogenous leukemia), DNA, whole genome next-generation sequencing to detect gene rearrangement(s), blood or bone marrow, report of specific gene rearrangement(s)
|
MatePair Acute Myeloid Leukemia Panel
|
Mayo Clinic, Laboratory Developed Test
|
Mayo Clinic
|
11/30/2017
|
|
0057U
|
Oncology (solid organ neoplasia), mRNA, gene expression profiling by massively parallel sequencing for analysis of 51 genes, utilizing formalin-fixed paraffin-embedded tissue, algorithm reported as a normalized percentile rank
|
RNA-Sequencing by NGS
|
OmniSeq, Inc, Life Technologies Corporation
|
OmniSeq, Inc, Life Technologies Corporation
|
11/30/2017
|
|
0058U
|
Oncology (Merkel cell carcinoma), detection of antibodies to the Merkel cell polyoma virus oncoprotein (small T antigen), serum, quantitative
|
Merkel SmT Oncoprotein Antibody Titer
|
University of Washington, Department of Laboratory Medicine
|
University of Washington, Department of Laboratory Medicine
|
11/30/2017
|
|
0059U
|
Oncology (Merkel cell carcinoma), detection of antibodies to the Merkel cell polyoma virus capsid protein (VP1), serum, reported as positive or negative
|
Merkel Virus VP1 Capsid Antibody
|
University of Washington, Department of Laboratory Medicine
|
University of Washington, Department of Laboratory Medicine
|
11/30/2017
|
|
0060U
|
Twin zygosity, genomic targeted sequence analysis of chromosome 2, using circulating cell-free fetal DNA in maternal blood
|
Twins Zygosity PLA
|
Natera, Inc
|
Natera, Inc
|
11/30/2017
|
|
0061U
|
Transcutaneous measurement of five biomarkers (tissue oxygenation [StO2], oxyhemoglobin [ctHbO2], deoxyhemoglobin [ctHbR], papillary and reticular dermal hemoglobin concentrations [ctHb1 and ctHb2]), using spatial frequency domain imaging (SFDI) and multi-spectral analysis
|
Transcutaneous multispectral measurement of tissue oxygenation and hemoglobin using spatial frequency domain imaging (SFDI)
|
Modulated Imaging, Inc
|
Modulated Imaging, Inc
|
11/30/2017
|
|
0062U
|
Autoimmune (systemic lupus erythematosus), IgG and IgM analysis of 80 biomarkers, utilizing serum, algorithm reported with a risk score
|
SLE-key® Rule Out
|
Veracis Inc
|
Veracis Inc
|
11/30/2017
|
|
0063U
|
Neurology (autism), 32 amines by LC-MS/MS, using plasma, algorithm reported as metabolic signature associated with autism spectrum disorder
|
NPDX ASD ADM Panel I
|
Stemina Biomarker Discovery, Inc
|
Stemina Biomarker Discovery, Inc d/b/a NeuroPointDX
|
11/30/2017
|
|
0064U
|
Antibody, Treponema pallidum, total and rapid plasma reagin (RPR), immunoassay, qualitative
|
BioPlex 2200 Syphilis Total & RPR Assay
|
Bio-Rad Laboratories
|
Bio-Rad Laboratories
|
11/30/2017
|
|
0065U
|
Syphilis test, non-treponemal antibody, immunoassay, qualitative (RPR)
|
BioPlex 2200 RPR Assay
|
Bio-Rad Laboratories
|
Bio-Rad Laboratories
|
11/30/2017
|
|
0066U
|
Placental alpha-micro globulin-1 (PAMG-1), immunoassay with direct optical observation, cervico-vaginal fluid, each specimen
|
PartoSure™ Test
|
Parsagen Diagnostics, Inc
|
Parsagen Diagnostics, Inc, a QIAGEN Company
|
11/30/2017
|
|
0067U
|
Oncology (breast), immunohistochemistry, protein expression profiling of 4 biomarkers (matrix metalloproteinase-1 [MMP-1], carcinoembryonic antigen-related cell adhesion molecule 6 [CEACAM6], hyaluronoglucosaminidase [HYAL1], highly expressed in cancer protein [HEC1]), formalin-fixed paraffin-embedded precancerous breast tissue, algorithm reported as carcinoma risk score
|
BBDRisk Dx™
|
Silbiotech, Inc
|
Silbiotech, Inc
|
11/30/2017
|
|
0068U
|
Candida species panel (C. albicans, C. glabrata, C. parapsilosis, C. kruseii, C. tropicalis, and C. auris), amplified probe technique with qualitative report of the presence or absence of each species
|
MYCODART Dual Amplification Real Time PCR Panel for 6 Candida species
|
RealTime Laboratories, Inc
|
RealTime Laboratories, Inc
|
11/30/2017
|
|
0069U
|
Oncology (colorectal), microRNA, RT-PCR expression profiling of miR-31-3p, formalin-fixed paraffin-embedded tissue, algorithm reported as an expression score
|
miR-31now™
|
GoPath Laboratories
|
GoPath Laboratories
|
11/30/2017
|
|
0070U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, common and select rare variants (ie, *2, *3, *4, *4N, *5, *6, *7, *8, *9, *10, *11, *12, *13, *14A, *14B, *15, *17, *29, *35, *36, *41, *57, *61, *63, *68, *83, *xN)
|
CYP2D6 Common Variants and Copy Number
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0071U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, full gene sequence (List separately in addition to code for primary procedure)
|
CYP2D6 Full Gene Sequencing
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0072U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D6-2D7 hybrid gene) (List separately in addition to code for primary procedure)
|
CYP2D6-2D7 Hybrid Gene Targeted Sequence Analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0073U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, CYP2D7-2D6 hybrid gene) (List separately in addition to code for primary procedure)
|
CYP2D7-2D6 Hybrid Gene Targeted Sequence Analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0074U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, non-duplicated gene when duplication/multiplication is trans) (List separately in addition to code for primary procedure)
|
CYP2D6 trans-duplication/multiplication non-duplicated gene targeted sequence analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0075U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 5’ gene duplication/multiplication) (List separately in addition to code for primary procedure)
|
CYP2D6 5’ gene duplication/multiplication targeted sequence analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0076U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, targeted sequence analysis (ie, 3’ gene duplication/ multiplication) (List separately in addition to code for primary procedure)
|
CYP2D6 3’ gene duplication/multiplication targeted sequence analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0077U
|
Immunoglobulin paraprotein (M-protein), qualitative, immunoprecipitation and mass spectrometry, blood or urine, including isotype
|
M-Protein Detection and Isotyping by MALDI-TOF Mass Spectrometry
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
0078U
|
Pain management (opioid-use disorder) genotyping panel, 16 common variants (ie, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), buccal swab or other germline tissue sample, algorithm reported as positive or negative risk of opioid-use disorder
|
INFINITI® Neural Response Panel
|
PersonalizeDx Labs
|
AutoGenomics Inc
|
11/30/2017
|
|
0079U
|
Comparative DNA analysis using multiple selected single-nucleotide polymorphisms (SNPs), urine and buccal DNA, for specimen identity verification
|
ToxLok™
|
InSource Diagnostics
|
InSource Diagnostics
|
11/30/2017
|
|
0080U
|
Oncology (lung), mass spectrometric analysis of galectin-3-binding protein and scavenger receptor cysteine-rich type 1 protein M130, with five clinical risk factors (age, smoking status, nodule diameter, nodule-spiculation status and nodule location), utilizing plasma, algorithm reported as a categorical probability of malignancy
|
BDX-XL2, Biodesix®, Inc
|
Biodesix®, Inc
|
Biodesix®, Inc
|
11/30/2018
|
|
0081U
|
Oncology (uveal melanoma), mRNA, gene-expression profiling by real-time RT-PCR of 15 genes (12 content and 3 housekeeping genes), utilizing fine needle aspirate or formalin-fixed paraffin-embedded tissue, algorithm reported as risk of metastasis
|
DecisionDx®-UM
|
Castle Biosciences, Inc
|
Castle Biosciences, Inc
|
11/30/2018
|
|
0082U
|
Drug test(s), definitive, 90 or more drugs or substances, definitive chromatography with mass spectrometry, and presumptive, any number of drug classes, by instrument chemistry analyzer (utilizing immunoassay), urine, report of presence or absence of each drug, drug metabolite or substance with description and severity of significant interactions per date of service
|
NextGen Precision™ Testing
|
Precision Diagnostics LBN Precision Toxicology, LLC
|
Precision Diagnostics LBN Precision Toxicology, LLC
|
11/30/2018
|
|
0083U
|
Oncology, response to chemotherapy drugs using motility contrast tomography, fresh or frozen tissue, reported as likelihood of sensitivity or resistance to drugs or drug combinations
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Onco4D™
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Animated Dynamics, Inc
|
Animated Dynamics, Inc
|
11/30/2018
|
