| A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | |
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1 | Item # | Code # | Final Code # | Code Type | Category | Long Code Descriptor | ||||||||||||||||||||
2 | 2 | 0562U | TBD | Reconsidered | TBD | Oncology (solid tumor), targeted genomic sequence analysis, 33 genes, detection of single-nucleotide variants (snvs), insertions and deletions, copy-number amplifications, and translocations in human genomic circulating cell-free dna, plasma, reported as presence of actionable variants | ||||||||||||||||||||
3 | 3 | 0575U | TBD | Reconsidered | TBD | Transplantation medicine (liver allograft rejection), mirna gene expression profiling by rt-pcr of 4 genes (mir-122, mir-885, mir-23a housekeeping, spike-in control), serum, algorithm reported as risk of liver allograft rejection | ||||||||||||||||||||
4 | 4 | 0600U | TBD | New PLA | TBD | Infectious disease (wound infection), identification of 65 organisms and 30 antibiotic resistance genes, wound swab, real-time PCR, reported as positive or negative for each organism | ||||||||||||||||||||
5 | 5 | 0601U | TBD | New PLA | TBD | Infectious disease (periprosthetic joint infection), analysis of 11 biomarkers (alpha defensins 1–3, C-reactive protein, microbial antigens for Staphylococcus [SPA, SPB], Enterococcus, Candida, and C. acnes, total nucleated cell count, percent neutrophils, RBC count, and absorbance at 280 nm) using immunoassays, hematology, clinical chemistry, synovial fluid, and diagnostic algorithm reported as a probability score | ||||||||||||||||||||
6 | 6 | 0602U | TBD | New PLA | TBD | Endocrinology (diabetes), insulin (INS) gene methylation using digital droplet PCR, insulin, and C-peptide immunoassay, serum, Hemoglobin A1c immunoassay, whole blood, algorithm reported as diabetes-risk score | ||||||||||||||||||||
7 | 7 | 0603U | TBD | New PLA | TBD | Drug assay, presumptive, 77 drugs or metabolites, urine, liquid chromatography with tandem mass spectrometry (LC-MS/MS), results reported as positive or negative | ||||||||||||||||||||
8 | 8 | 0604U | TBD | New PLA | TBD | Allergy and immunology (chronic recurrent angioedema), 4 bradykinin peptides, liquid chromatography and tandem mass spectrometry (LC-MS/ MS), whole blood, quantitative | ||||||||||||||||||||
9 | 9 | 0605U | TBD | New PLA | TBD | Allergy and immunology (hereditary alpha tryptasemia), DNA, analysis of TPSAB1 gene copy number variation using digital PCR, whole blood, results reported with genotype-specific interpretation of alpha-tryptase copy number and algorithmic classification as normal or abnormal | ||||||||||||||||||||
10 | 10 | 0606U | TBD | New PLA | TBD | Hematology (red cell membrane disorders), RBCs, osmotic gradient ektacytometry, whole blood, quantitative | ||||||||||||||||||||
11 | 11 | 0607U | TBD | New PLA | TBD | Reproductive medicine (endometrial microbiome assessment), real-time PCR analysis for 31 bacterial DNA targets from endometrial biopsy, reported with quantified levels of bacterial presence and targeted treatment recommendations | ||||||||||||||||||||
12 | 12 | 0608U | TBD | New PLA | TBD | Reproductive medicine (endometrial microbiome assessment), real-time PCR analysis for 10 bacterial DNA targets from endometrial biopsy, reported with quantified levels of bacterial presence and targeted treatment recommendations (Do not report 0608U in conjunction with 0607U) | ||||||||||||||||||||
13 | 13 | 0609U | TBD | New PLA | TBD | Oncology (prostate), immunoassay for total prostate-specific antigen (PSA) and free PSA, serum or plasma, combined with clinical features, algorithm reported as a probability score for clinically significant prostate cancer | ||||||||||||||||||||
14 | 14 | 0610U | TBD | New PLA | TBD | Infectious disease (antimicrobial susceptibility), phenotypic antimicrobial susceptibility testing of positive blood culture using microfluidic sensor technology to quantify bacterial growth response to multiple antibiotic types, reporting categorical susceptibility (susceptible, susceptible dose dependent, intermediate, resistant), minimum inhibitory concentration, and interpretive comments | ||||||||||||||||||||
15 | 15 | 0611U | TBD | New PLA | TBD | Oncology (liver), analysis of over 1,000 methylated regions, cell-free DNA from plasma, algorithm reported as a quantitative result (For additional PLA code with identical clinical descriptor, see 0612U. See Appendix O or the most current listing on the AMA CPT website to determine appropriate code assignment) | ||||||||||||||||||||
16 | 16 | 0612U | TBD | New PLA | TBD | Oncology (liver), analysis of over 1,000 methylated regions, cell-free DNA from plasma, algorithm reported as a quantitative result (For additional PLA code with identical clinical descriptor, see 0611U. See Appendix O or the most current listing on the AMA CPT website to determine appropriate code assignment) | ||||||||||||||||||||
17 | 17 | 0613U | TBD | New PLA | TBD | Oncology (urothelial carcinoma), DNA methylation and mutation analysis of 6 biomarkers (TWIST1, OTX1, ONECUT2, FGFR3, HRAS, TERT promoter region), methylation-specific PCR and targeted next-generation sequencing, urine, algorithm reported as a probability index for bladder cancer and upper tract urothelial carcinoma | ||||||||||||||||||||
18 | 18 | 0614U | TBD | New PLA | TBD | Inborn error of metabolism (primary mitochondrial disease), mitochondrial analysis of 4 enzyme complexes by stained blue native polyacrylamide gel electrophoresis (PAGE), frozen tissue (muscle, liver, heart, cultured skin fibroblasts), diagnostic qualitative result | ||||||||||||||||||||
19 | 19 | 0615U | TBD | New PLA | TBD | Borrelia burgdorferi (Lyme disease), antibody detection of 26 recombinant protein groups, by immunoassay, IgM | ||||||||||||||||||||
20 | 20 | 0616U | TBD | New PLA | TBD | Neurology (dementia), DNA methylation analysis of more than 30,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
21 | 21 | 0617U | TBD | New PLA | TBD | Cardiovascular (atherosclerotic cardiovascular disease [ASCVD]), DNA methylation analysis of more than 20,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
22 | 22 | 0618U | TBD | New PLA | TBD | Psychiatry (bipolar disorder), DNA methylation analysis of more than 10,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
23 | 23 | 0619U | TBD | New PLA | TBD | Pulmonary (chronic obstructive pulmonary disease [COPD]), DNA methylation analysis of more than 18,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
24 | 24 | 0620U | TBD | New PLA | TBD | Oncology (hepatocellular carcinoma), DNA methylation analysis of more than 5,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
25 | 25 | 0621U | TBD | New PLA | TBD | Infectious disease (Lyme borreliosis), DNA methylation analysis of more than 10,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
26 | 26 | 0622U | TBD | New PLA | TBD | Psychiatry (major depressive disorder), DNA methylation analysis of more than 20,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
27 | 27 | 0623U | TBD | New PLA | TBD | Autoimmune (multiple sclerosis), DNA methylation analysis of more than 5,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
28 | 28 | 0624U | TBD | New PLA | TBD | Hepatology (nonalcoholic steatohepatitis [NASH]), DNA methylation analysis of 5,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
29 | 29 | 0625U | TBD | New PLA | TBD | Endocrinology (osteoporosis), DNA methylation analysis of more than 5,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
30 | 30 | 0626U | TBD | New PLA | TBD | Neurology (Parkinson disease), DNA methylation analysis of more than 20,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
31 | 31 | 0627U | TBD | New PLA | TBD | Psychiatry (schizophrenia), DNA methylation analysis of more than 15,000 sites, whole blood, algorithm reported as positive or negative risk | ||||||||||||||||||||
32 | 32 | 0628U | TBD | New PLA | TBD | Nephrology (kidney disease-related genetic conditions), genomic analysis, renal disease panel, saliva, DNA, next-generation sequencing of 449 genes, reported as pathogenic or likely pathogenic variants of uncertain significance or risk alleles | ||||||||||||||||||||
33 | 33 | 0629U | TBD | New PLA | TBD | Infectious disease (tuberculosis), DNA, analysis of 1 target by PCR with clustered regularly interspaced short palindromic repeat (CRISPR)-based probe detection, plasma or serum, qualitative report as detected or not detected | ||||||||||||||||||||
34 | 34 | 0630U | TBD | New PLA | TBD | Oncology (breast), mRNA, gene expression profiling by microarray of 80 genes (80 content and 465 housekeeping), utilizing formalin-fixed paraffin-embedded tissue (FFPE), algorithm reported as an index that is diagnostic of a molecular subtype (luminal, basal, Her2) | ||||||||||||||||||||
35 | 35 | 0631U | TBD | New PLA | TBD | Oncology (solid tumor), DNA, sequence analysis of 15 genes including BRCA1 and BRCA2 for identification of clonal hematopoiesis, blood, reported as tumor-derived or nontumor-derived | ||||||||||||||||||||
36 | 36 | 0632U | TBD | New PLA | TBD | Red blood cell antigen (fetal RhD gene analysis), multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) of circulating cell-free DNA (cfDNA), plasma from pregnant individuals known to be RhD negative, reported as detected or not detected (Do not report X219U in conjunction with 0488U) | ||||||||||||||||||||
37 | 37 | 0633U | TBD | New PLA | TBD | Obstetrics (single-gene noninvasive prenatal test), cell-free DNA (cfDNA), next-generation sequencing (NGS) analysis of 1 or more targets (eg, CFTR, SMN1, HBB, HBA1, HBA2) to identify paternally inherited pathogenic variants and to determine fetal inheritance of maternal mutation, using maternal blood sample, algorithm reported as a fetal risk score | ||||||||||||||||||||
38 | 38 | 0634U | TBD | New PLA | TBD | Oncology (breast cancer), cell-free DNA (cfDNA), evaluation of 11 ESR1 variants (E380Q, S463P, L536R, Y537C, Y537N, Y537S, D538G, V422del, L536H, L536P, Y537D) using droplet digital PCR (ddPCR), plasma, reported as positive or negative | ||||||||||||||||||||
39 | 39 | 0635U | TBD | New PLA | TBD | Autoimmune (atopic dermatitis), mRNA, next-generation sequencing (NGS), gene expression profiling of 487 genes, noninvasive skin-surface scraping, algorithm reported as likelihood of response to therapy | ||||||||||||||||||||
40 | 40 | 0636U | TBD | New PLA | TBD | Babesia (Babesiosis), antibody detection of 20 recombinant protein groups, by immunoassay, IgG | ||||||||||||||||||||
41 | 41 | 0637U | TBD | New PLA | TBD | Babesia (Babesiosis), antibody detection of 20 recombinant protein groups, by immunoassay, IgM | ||||||||||||||||||||
42 | 42 | 0638U | TBD | New PLA | TBD | Bartonella (Bartonellosis), antibody detection of 32 recombinant protein groups, by immunoassay, IgG | ||||||||||||||||||||
43 | 43 | 0639U | TBD | New PLA | TBD | Bartonella (Bartonellosis), antibody detection of 32 recombinant protein groups, by immunoassay, IgM | ||||||||||||||||||||
44 | 44 | 0640U | TBD | New PLA | TBD | Oncology (leptomeningeal metastases), tumor cell selection, identification, detection and enumeration based on differential CD318(CDCP1), SUSD2, CD340(erbB2/HER2), HGFR/cMET, FOLR1, EGFR, N cadherin, MUC1, EpCAM, and TROP2 antibody biomarkers, cerebrospinal fluid, reported as detection and quantification of tumor cells | ||||||||||||||||||||
45 | 45 | 0641U | TBD | New PLA | TBD | Oncology (minimal residual disease [MRD]), tumor DNA, next-generation sequencing (NGS), using formalin-fixed paraffin-embedded (FFPE) tissue and blood samples, initial (baseline) assessment | ||||||||||||||||||||
46 | 46 | 0642U | TBD | New PLA | TBD | Oncology (minimal residual disease [MRD]), tumor DNA, next-generation sequencing (NGS), whole blood, comparison to previously performed analyses, reported as trend in circulating tumor DNA (ctDNA) level | ||||||||||||||||||||
47 | 47 | 0643U | TBD | New PLA | TBD | Oncology (genitourinary cancer), cell-free circulating tumor DNA (ctDNA), 200 genes, next-generation sequencing (NGS), interrogation for single-nucleotide variants (SNVs), insertions/deletions, gene rearrangements, copy number alterations, and tumor mutation burden, using urine, identify and report mutations with clinical actionability | ||||||||||||||||||||
48 | 48 | 0644U | TBD | New PLA | TBD | Oncology (leukemia), minimal residual disease (MRD) detection for rearrangements, blood or bone marrow, personalized assay design and baseline quantification | ||||||||||||||||||||
49 | 49 | 0645U | TBD | New PLA | TBD | Oncology (leukemia), minimal residual disease (MRD) detection for rearrangements, based on digital PCR, blood or bone marrow, reported as not detected or detected with estimated abundance | ||||||||||||||||||||
50 | 50 | 0646U | TBD | New PLA | TBD | Oncology (molecular residual disease), whole genome sequence analysis, cell-free DNA, whole blood, and formalin-fixed paraffin-embedded (FFPE) tumor tissue DNA, baseline assessment | ||||||||||||||||||||
51 | 51 | 0647U | TBD | New PLA | TBD | Oncology (molecular residual disease), whole genome sequence analysis, cell-free DNA (cfDNA), whole blood, assessment utilizing patient-specific tumor information, reported as negative or percent circulating tumor DNA (ctDNA) | ||||||||||||||||||||
52 | 52 | 0648U | TBD | New PLA | TBD | Oncology (solid tumor), targeted genomic sequencing analysis, to detect deletions, insertions, and substitutions in 42 genes, copy number amplifications in 10 genes, and fusions and splice variants in 18 driver genes from DNA and RNA extracted from formalin-fixed paraffin-embedded (FFPE) tissue | ||||||||||||||||||||
53 | 53 | 0649U | TBD | New PLA | TBD | Neurology (Alzheimer disease), DNA, targeted next-generation sequencing (NGS) of AD-1 and AD-2 target regions, whole blood, prognostic algorithmic analysis, reported as categorization of cognitive status | ||||||||||||||||||||
54 | 54 | 0650U | TBD | New PLA | TBD | Drug metabolism (adverse drug reactions and drug response), genotyping of 9 genes (ie, CYP2D6, CYP2C19, G6PD, SLCO1B1, HLA-B*58:01, NAT2, CYP2C9, VKORC1, ABCG2), reported as metabolizer status and transporter function | ||||||||||||||||||||
55 | 55 | 0651U | TBD | New PLA | TBD | Oncology (hereditary cancer), genomic DNA, 55 hereditary cancer pre-dispositioned genes, next-generation sequencing (NGS) and digital multiplex ligation-dependent probe amplification for variants, small indels (<40 base pairs), using saliva, whole blood or nail clipping, interpretive clinical report with variant classification | ||||||||||||||||||||
56 | 56 | 0652U | TBD | New PLA | TBD | Drug metabolism (adverse drug reactions), DNA analysis of 13 genes by targeted genotyping, using saliva or buccal swab, reported as diplotype and metabolizer status | ||||||||||||||||||||
57 | 57 | 0653U | TBD | New PLA | TBD | Nephrology (inherited kidney disorders), DNA, analysis of approximately 700 genes associated with inherited kidney diseases by exome sequencing, using whole blood, saliva, or nail clipping, reported as an interpretive clinical report classifying pathogenic and likely pathogenic variants | ||||||||||||||||||||
58 | 58 | 0654U | TBD | New PLA | TBD | Inborn error of metabolism (primary mitochondrial disease), mitochondrial analysis of 1 enzyme complex by western blot analysis, using cultured skin fibroblasts, diagnostic qualitative result | ||||||||||||||||||||
59 | 59 | 0655U | TBD | New PLA | TBD | Inborn error of metabolism (primary mitochondrial disease), mitochondrial analysis of 1 enzyme complex by spectrophotometric kinetic assay, using cultured skin fibroblasts, diagnostic quantitative result | ||||||||||||||||||||
60 | 60 | 0656U | TBD | New PLA | TBD | Inborn error of metabolism (primary mitochondrial disease), mitochondrial analysis of 1 enzyme complex by radioactive activity assay, using cultured skin fibroblasts, diagnostic quantitative result | ||||||||||||||||||||
61 | 61 | 0657U | TBD | New PLA | TBD | Rare diseases (constitutional/heritable disorders), rapid whole genome sequence analysis of comparator nuclear and mitochondrial DNA by next-generation sequencing (NGS), using blood or buccal sample, relevant variants reported with proband results (Use 0657U in conjunction with 0658U) | ||||||||||||||||||||
62 | 62 | 0658U | TBD | New PLA | TBD | Rare diseases (constitutional/heritable disorders), rapid whole genome sequence analysis of nuclear and mitochondrial DNA by next-generation sequencing (NGS) for single-nucleotide variants (SNVs), insertions/deletions, copy number variants, uniparental disomy, and repeat expansions, using blood or buccal sample, identification and categorization of genetic variants (Use 0658U in conjunction with 0657U) | ||||||||||||||||||||
63 | 63 | 0659U | TBD | New PLA | TBD | Rare diseases (constitutional/heritable disorders), ultrarapid whole genome sequence analysis of nuclear and mitochondrial DNA by next-generation sequencing (NGS) for single-nucleotide variants (SNVs), insertions/deletions, copy number variants, uniparental disomy, and repeat expansions, using blood or buccal sample, identification and categorization of genetic variants | ||||||||||||||||||||
64 | 64 | 0580U | 0580U | Reconsidered | TBD | Borrelia burgdorferi, antibody detection of 24 recombinant protein groups, by immunoassay, IgG | ||||||||||||||||||||
65 | 72 | X250U | TBD | New | TBD | Rare diseases (constitutional/heritable disorders), whole genome and mitochondrial DNA sequence analysis, including small sequence changes, insertions/deletions, copy number variants, mobile element insertions, runs of homozygosity, aneuploidy, and inversions, short tandem repeat (STR) gene expansions, blood, saliva or genomic DNA, identification and categorization of genetic variants, proband and comparator (Do not report X250U in conjunction with 81425, 81426, 0212U, 0213U, 0214U, 0215U, 0567U, X272U) | ||||||||||||||||||||
66 | 73 | X251U | TBD | New | TBD | Human papillomavirus (HPV), genotypes 18, 31, 33, and 35, cell-free DNA (cfDNA), whole blood, multiplex digital droplet PCR (ddPCR), quantitative | ||||||||||||||||||||
67 | 74 | X252U | TBD | New | TBD | Transplantation medicine (kidney allograft rejection), mRNA, gene-expression profiling by real-time quantitative PCR of 12 genes (11 content and 1 housekeeping), urine, algorithm reported as a rejection risk score | ||||||||||||||||||||
68 | 75 | X253U | TBD | New | TBD | Transplantation medicine (allograft rejection), quantification of donor-derived cell-free DNA (cfDNA) using digital PCR analysis of 45 single-nucleotide polymorphisms, plasma, reported as quantity of donor-derived cfDNA in plasma to determine the probability of allograft rejection | ||||||||||||||||||||
69 | 76 | X254U | TBD | New | TBD | Oncology (hereditary hematologic cancer), genomic DNA, whole genome sequence (single-nucleotide variants, deletions/insertions, and characterized intronic variants), copy number variants, duplications/deletions, mobile element insertions and inversions, analysis of over 105 genes, genomic DNA isolated from blood, saliva, cultured skin fibroblasts (skin biopsy), identification and categorization of genetic variants | ||||||||||||||||||||
70 | 77 | X255U | TBD | New | TBD | Rare diseases (constitutional/heritable disorders), whole exome and mitochondrial DNA sequence analysis, including small sequence changes, deletions, duplications, short tandem repeat (STR) gene expansions, and variants in nonuniquely mappable regions, blood or saliva, identification and categorization of genetic variants, proband and comparator (Do not report X255U in conjunction with 81415, 81416, 0214U, 0215U, X303U) | ||||||||||||||||||||
71 | 78 | X256U | TBD | New | TBD | Obstetrics (fetal platelet antigen noninvasive prenatal test [NIPT]), cell-free DNA (cfDNA) sequence analysis for detection of fetal presence or absence of 1 human platelet antigen or more (HPA-1a, HPA-1b, HPA-3a, HPA-5b, and others) when performed, reported as maternal/fetal incompatibility detected or not detected per selected antigen | ||||||||||||||||||||
72 | 79 | X257U | TBD | New | TBD | Transplantation medicine (kidney allograft failure), RNA expression transcriptome by next-generation sequencing (NGS), profiling of 13 genes, post-transplant peripheral blood, algorithm reported as a risk score for predicting progressive fibrosis in the kidney allograft | ||||||||||||||||||||
73 | 80 | X258U | TBD | New | TBD | Comparative analysis using short tandem repeat (STR) markers, patient and comparative specimen, DNA, buccal swab and tissue, reported match or mismatch | ||||||||||||||||||||
74 | 81 | X259U | TBD | New | TBD | Hepatology (metabolic dysfunction-associated steatohepatitis [MASH]), enzyme-linked immunosorbent assay (ELISA) for YKL40 and quantitative reverse transcription polymerase chain reaction (RT-qPCR) for miR-34a-5p, serum, algorithm reported as a single score for MASH activity and fibrosis | ||||||||||||||||||||
75 | 82 | X261U | TBD | New | TBD | Tobacco use, DNA analysis of 2 methylation markers (1 content: cg05575921 [AHRR] and 1 normalizing: cg08141395), methylation-sensitive digital PCR, saliva, algorithm reported as quantitative percent methylation and estimated average cigarette use per day | ||||||||||||||||||||
76 | 83 | X262U | TBD | New | TBD | Oncology (head and neck), circulating tumor DNA (ctDNA), tumor-informed next-generation sequencing (NGS) analysis for 699 genes of patient-specific somatic variants identified from primary tumor tissue, postoperative lymphatic exudate specimen, algorithm reported as presence or absence of ctDNA | ||||||||||||||||||||
77 | 84 | X263U | TBD | New | TBD | Tobacco use, DNA analysis of 1 methylation marker (cg05575921 [AHRR]), methylation-sensitive digital PCR, whole blood, algorithm reported as quantitative percentage methylation and estimated average cigarette use per day | ||||||||||||||||||||
78 | 85 | X264U | TBD | New | TBD | Infectious disease (wound infection), DNA, multiplex real-time PCR, wound swab, detection of 27 microbial targets and 28 antibiotic resistance targets, reported as semiquantitative for bacterial and fungal targets, and qualitative for viral- and antibiotic-resistance target | ||||||||||||||||||||
79 | 86 | X265U | TBD | New | TBD | Alcohol use disorder, DNA analysis of 4 methylation markers (cg02583484, cg04987734, cg09935388, cg04583842), methylation-sensitive digital PCR, whole blood, algorithm reported as a summed T-score | ||||||||||||||||||||
80 | 87 | X266U | TBD | New | TBD | Inborn error of metabolism (primary mitochondrial disease), determination of fibroblast growth factor 21 (FGF21) concentration by enzyme-linked immunosorbent assay (ELISA), serum or plasma, diagnostic quantitative result | ||||||||||||||||||||
81 | 88 | X268U | TBD | New | TBD | Oncology (prostate), mRNA, next-generation sequencing (NGS) gene expression profiling of 22 genes, formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as risk score | ||||||||||||||||||||
82 | 89 | X269U | TBD | New | TBD | Oncology (monoclonal gammopathy), immunoprecipitation and matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) mass spectrometry, identification of intact monoclonal immunoglobulin isotypes (IgG, IgA, IgM, kappa, lambda), and M-protein concentrations in conjunction with turbidimetry, blood, semiquantitative | ||||||||||||||||||||
83 | 90 | X271U | TBD | New | TBD | Rare diseases (constitutional/heritable disorders), whole genome sequence analysis combination of short and long reads for single-nucleotide variants, insertions/deletions and characterized intronic variants, copy number variants, duplications/deletions, mobile element insertions, runs of homozygosity, aneuploidy, and inversions, mitochondrial DNA sequence and deletions, short tandem repeat (STR) genes, methylation status of selected regions, blood, saliva, amniocentesis, chorionic villus sample or tissue, identification and categorization of genetic variant, proband and comparator (Do not report X271U in conjunction with 81425, 81426, 0212U, 0213U, X302U) | ||||||||||||||||||||
84 | 91 | X272U | TBD | New | TBD | Rare diseases (constitutional/heritable disorders), whole genome and mitochondrial DNA sequence analysis, including small sequence changes, insertions/deletions, copy number variants, duplications/deletions, mobile element insertions, runs of homozygosity, aneuploidy, and inversions, short tandem repeat (STR) gene expansions, blood, saliva or genomic DNA, identification and categorization of genetic variants proband and 2 comparators (Do not report X272U in conjunction with 81425, 81426, 0212U, 0213U, 0214U, 0215U, 0567U, X250U) | ||||||||||||||||||||
85 | 92 | X273U | TBD | New | TBD | Oncology (lung cancer), DNA analysis of 1 methylation marker (cg05575921), methylation-sensitive digital PCR, whole blood, algorithm results reported as the 20-year-hazard ratio for lung cancer | ||||||||||||||||||||
86 | 93 | X274U | TBD | New | TBD | Oncology (central nervous system), low-pass whole genome sequence analysis of cerebrospinal fluid, interrogation for chromosome arm-level and focal losses and gains | ||||||||||||||||||||
87 | 94 | X278U | TBD | New | TBD | Oncology (colorectal cancer), analysis of minimal residual disease (MRD), next-generation sequencing (NGS), circulating tumor DNA (ctDNA) analysis in whole blood and tumor for baseline assessment to evaluate current MRD status and for comparisons to subsequent MRD assessments | ||||||||||||||||||||
88 | 95 | X279U | TBD | New | TBD | Carrier screening (cystic fibrosis, spinal muscular atrophy, beta hemoglobinopathies [including sickle cell disease], alpha thalassemia, and Duchenne muscular dystrophy), genomic sequence analysis panel, 6 genes (CFTR, SMN1, HBB, HBA1, HBA2, DMD) (Do not report X279U in conjunction with 81443) | ||||||||||||||||||||
89 | 96 | X280U | TBD | New | TBD | Oncology (hereditary cancer), genome sequence for 117 genes (single-nucleotide variants, deletions/insertions, and characterized intronic variants), copy number variants, duplications/deletions, mobile element insertions and inversions, blood, saliva, cultured skin fibroblasts (skin biopsy) or extracted genomic DNA, diagnostic, identification and categorization of genetic variants | ||||||||||||||||||||
90 | 97 | X282U | TBD | New | TBD | Oncology (pancreas), DNA, genome sequence with 5-hydroxymethylcytosine (5hmC) enrichment and glycan biomarker analysis, whole blood or plasma, algorithm reported as cancer detected or not detected | ||||||||||||||||||||
91 | 98 | X283U | TBD | New | TBD | Human papillomavirus (HPV), genotype 16, cell-free DNA (cfDNA), whole blood, digital droplet PCR (ddPCR), quantitative | ||||||||||||||||||||
92 | 99 | X285U | TBD | New | TBD | Rare diseases (constitutional/heritable disorders), whole genome sequence analysis, including small sequence changes, copy number variants, deletions, duplications, mobile element insertions, uniparental disomy (UPD), inversions, aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, short tandem repeat (STR) gene expansions and maternal cell contamination, fetal sample, identification and categorization of genetic variants, proband and maternal comparator | ||||||||||||||||||||
93 | 100 | X286U | TBD | New | TBD | Oncology (lung cancer), DNA analysis of 2 methylation markers (1 content: cg05575921 and 1 normalizing: cg08141395), methylation-sensitive digital PCR, saliva, algorithm results reported as the 20-year-hazard ratio for lung cancer | ||||||||||||||||||||
94 | 101 | X287U | TBD | New | TBD | Infectious disease (Bartonella species, Borrelia species, and Babesia species), multiplex digital PCR for detection of DNA at the genus level for each species, blood, qualitative reporting of presence or absence of each pathogen at the genus level | ||||||||||||||||||||
95 | 102 | X291U | TBD | New | TBD | Rare diseases (constitutional/heritable disorders), whole genome sequence analysis, including small sequence changes, copy number variants, deletions, duplications, mobile element insertions, uniparental disomy (UPD), inversions, aneuploidy, mitochondrial genome sequence analysis with heteroplasmy and large deletions, short tandem repeat (STR) gene expansions and maternal cell contamination, fetal sample, identification and categorization of genetic variants, proband and 2 comparators | ||||||||||||||||||||
96 | 103 | X292U | TBD | New | TBD | Cardiology (peripheral artery disease [PAD]), analysis of 3 proteins (midkine, angiopoietin-1, and kidney injury molecule-1 [KIM-1]), immunoassay, plasma, algorithm reported as a risk score for obstructive PAD | ||||||||||||||||||||
97 | 104 | X293U | TBD | New | TBD | Alcohol use disorder, DNA analysis of 5 methylation markers (4 content: cg02583484, cg04987734, cg09935388, cg04583842, and 1 normalizing: cg08141395), methylation-sensitive digital PCR, whole blood or saliva, algorithm reported as a summed T-score | ||||||||||||||||||||
98 | 105 | X294U | TBD | New | TBD | Oncology (colorectal cancer), analysis of minimal residual disease (MRD) using patient-specific assays, reported as amount of circulating tumor DNA (ctDNA) detection and trend over time | ||||||||||||||||||||
99 | 106 | X295U | TBD | New | TBD | Oncology (solid organ), targeted genomic sequence analysis, formalin-fixed paraffin-embedded (FFPE) tumor tissue, RNA analysis, 350 or more genes for RNA alterations (eg, gene rearrangements and splice isoforms) | ||||||||||||||||||||
100 | 107 | X298U | TBD | New | TBD | Obesity, DNA genotyping, analysis of up to 41 genes, buccal swab or blood specimen, patient biometrics, risk-score algorithm to identify a predisposition to up to 4 phenotypes, reported as likelihood to benefit from therapeutics |