| 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
|
PreciseTypeÆ HEA Test
|
Immucor, Inc.
|
Immucor, Inc.
|
02/01/2017
|
|
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
|
PolypDXô
|
Atlantic Diagnostic Laboratories, LLC
|
Metabolomic Technologies Inc.
|
02/01/2017
|
|
0003U
|
Oncology (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.
|
02/01/2017
|
|
0005U
|
Oncology (prostate) gene expression profile by real-time RT-PCR of 3 genes (ERG, PCA3, and SPDEF), urine, algorithm reported as risk score
|
ExosomeDxÆProstate (IntelliScore)
|
Exosome Diagnostics, Inc.
|
Exosome Diagnostics, Inc.
|
05/01/2017
|
|
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
|
Aegis Sciences Corporation
|
07/01/2018
|
|
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
|
08/01/2017
|
|
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, predictive, reported as positive or negative for resistance to clarithromycin, fluoroquinolones, metronidazole, amoxicillin, tetracycline and rifabutin
|
AmHPR Helicobacter pylori Antibiotic Resistance Next Generation Sequencing Panel
|
American Molecular Laboratories, Inc.
|
American Molecular Laboratories, Inc.
|
08/01/2017
|
|
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
|
DEPArrayTM HER2
|
PacificDx
|
PacificDx
|
08/01/2017
|
|
0010U
|
Infectious disease (bacterial), strain typing by whole genome sequencing, phylogenetic-based report of strain relatedness, per submitted isolate
|
Bacterial StrainTyping by Whole Genome Sequencing (WGS)
|
Mayo Clinic
|
Mayo Clinic
|
08/01/2017
|
|
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 COREô
|
Cordant Health Solutions
|
Cordant Health Solutions
|
08/01/2017
|
|
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
|
08/01/2017
|
|
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
|
08/01/2017
|
|
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
|
08/01/2017
|
|
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
|
08/01/2017
|
|
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
|
08/01/2017
|
|
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
|
10/01/2017
|
|
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
|
10/01/2017
|
|
0020U
|
Drug test(s), presumptive, with definitive confirmation of positive results, any number of drug classes, urine, with specimen verification including DNA authentication in comparison to buccal DNA, per date of service
|
ToxLok
|
InSource Diagnostics
|
InSource Diagnostics
|
10/01/2017
|
|
0021U
|
Oncology (prostate), detection of 8 autoantibodies (ARF 6, NKX3-1, 5í-UTR-BMI1, CEP 164, 3í-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2), multiplexed immunoassay and flow cytometry serum, algorithm reported as risk score
|
ApifinyÆ
|
Armune BioScience
|
Armune BioScience Inc.
|
10/01/2017
|
|
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
|
Oncomineô Dx Target Test
|
Thermo Fisher Scientific
|
Thermo Fisher Scientific
|
10/01/2017
|
|
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
|
LeukoStratÆ CDx FLT3 Mutation Assay
|
LabPMM LLC, an Invivoscribe Technologies, Inc. company
|
Invivoscribe Technologies, Inc.
|
10/01/2017
|
|
0024U
|
Glycosylated acute phase proteins (GlycA), nuclear magnetic resonance spectroscopy, quantitative
|
GlycA
|
Laboratory Corporation of America
|
Laboratory Corporation of America
|
01/01/2018
|
|
0025U
|
Tenofovir, by liquid chromatography with tandem mass spectrometry (LC-MS/MS), urine, quantitative
|
UrSure Tenofovir Quantification Test
|
Synergy Medical Laboratories
|
UrSure Inc.
|
01/01/2018
|
|
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
|
01/01/2018
|
|
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
|
01/01/2018
|
|
0028U
|
CYP2D6 (cytochrome P450, family 2, subfamily D, polypeptide 6) (eg, drug metabolism) gene analysis, copy number variants, common variants with reflex to targeted sequence analysis
|
CYP2D6 Genotype Cascade
|
Mayo Clinic
|
Mayo Clinic
|
01/01/2018
|
|
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
|
01/01/2018
|
|
0030U
|
Drug metabolism (warfarin drug response), targeted sequence analysis (ie, CYP2C9, CYP4F2, VKORC1, rs12777823)
|
Warfarin Response Genotype
|
Mayo Clinic
|
Mayo Clinic
|
01/01/2018
|
|
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
|
01/01/2018
|
|
0032U
|
COMT (catechol-O-methyltransferase)(drug metabolism) gene analysis, c.472G>A (rs4680) variant
|
Catechol-O-Methyltransferase (COMT) Genotype
|
Mayo Clinic
|
Mayo Clinic
|
01/01/2018
|
|
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
|
01/01/2018
|
|
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
|
01/01/2018
|
|
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
|
N/A
|
04/01/2018
|
|
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
|
04/01/2018
|
|
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 CDxô (F1CDx)
|
Foundation Medicine, Inc.
|
Foundation Medicine, Inc.
|
04/01/2018
|
|
0038U
|
Vitamin D, 25 hydroxy D2 and D3, by LC-MS/MS, serum microsample, quantitative
|
SensievaTM Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay
|
InSource Diagnostics
|
null
|
04/01/2018
|
|
0039U
|
Deoxyribonucleic acid (DNA) antibody; double stranded, high avidity
|
Anti-dsDNA, High Salt/Avidity
|
University of Washington, Department of Laboratory Medicine
|
Bio-Rad
|
04/01/2018
|
|
0040U
|
BCR/ABL1 (t(9;22)) (eg, chronic myelogenous leukemia) translocation analysis, major breakpoint, quantitative
|
MRDx BCR-ABL Test
|
MolecularMD
|
MolecularMD
|
04/01/2018
|
|
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)
|
04/01/2018
|
|
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)
|
04/01/2018
|
|
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).
|
04/01/2018
|
|
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)
|
04/01/2018
|
|
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 DXÆ Breast DCIS Scoreô Test
|
Genomic Health, Inc.
|
Genomic Health, Inc.
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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.
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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.
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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.
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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
|
07/01/2018
|
|
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.
|
07/01/2018
|
|
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.
|
07/01/2018
|
