Códigos de patología y laboratorio que requieren documentación

Evite impactos negativos en sus reclamaciones proporcionando registros médicos con su presentación de reclamación inicial para los códigos de patología y laboratorio que se enumeran a continuación (en inglés). Para obtener más información, consulte nuestro artículo: Nuevo proceso para códigos de patología y laboratorio.

Código Descripción Vigente "desde"
fecha de servicio
Vigente "hasta"
fecha de servicio
0020M Oncology (central nervous system), analysis of 30000 DNA methylation loci by methylation array, utilizing DNA extracted from tumor tissue, diagnostic algorithm reported as probability of matching a reference tumor subclass 9/19/2024 Presente
0421U Oncology (colorectal) screening, quantitative real-time target and signal amplification of 8 RNA markers (GAPDH, SMAD4, ACY1, AREG, CDH1, KRAS, TNFRSF10B, EGLN2) and fecal hemoglobin, algorithm reported as a positive or negative for colorectal cancer risk 9/19/2024 12/31/2024
0422U Oncology (pan-solid tumor), analysis of DNA biomarker response to anti-cancer therapy using cell-free circulating DNA, biomarker comparison to a previous baseline pre-treatment cell-free circulating DNA analysis using next-generation sequencing, algorithm reported as a quantitative change from baseline, including specific alterations, if appropriate 9/19/2024 Presente
0425U Genome (e.g., unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis, each comparator genome (e.g., parents, siblings) 9/19/2024 Presente
0426U Genome (e.g., unexplained constitutional or heritable disorder or syndrome), ultra-rapid sequence analysis 9/19/2024 Presente
0428U Oncology (breast), targeted hybrid-capture genomic sequence analysis panel, circulating tumor DNA (ctDNA) analysis of 56 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutation burden 9/19/2024 12/31/2024
0429U Human papillomavirus (HPV), oropharyngeal swab, 14 high-risk types (i.e., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) 9/19/2024 Presente
0434U Drug metabolism (adverse drug reactions and drug response), genomic analysis panel, variant analysis of 25 genes with reported phenotypes 9/19/2024 Presente
0435U Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs), from cultured CSCs and primary tumor cells, categorical drug response reported based on cytotoxicity percentage observed, minimum of 14 drugs or drug combinations 9/19/2024 Presente
0436U Oncology (lung), plasma analysis of 388 proteins, using aptamer-based proteomics technology, predictive algorithm reported as clinical benefit from immune checkpoint inhibitor therapy 9/19/2024 Presente
0437U Psychiatry (anxiety disorders), mRNA, gene expression profiling by RNA sequencing of 15 biomarkers, whole blood, algorithm reported as predictive risk score 9/19/2024 Presente
0438U Drug metabolism (adverse drug reactions and drug response), buccal specimen, gene-drug interactions, variant analysis of 33 genes, including deletion/duplication analysis of CYP2D6, including reported phenotypes and impacted gene-drug interactions 9/19/2024 Presente
0439U Cardiology (coronary heart disease [CHD]), DNA, analysis of 5 single-nucleotide polymorphisms (SNPS) (rs11716050 [loc105376934], rs6560711 [wdr37], rs3735222 [scin/loc107986769], rs6820447 [intergenic], and rs9638144 [esyt2]) and 3 DNA methylation markers (cg00300879 [transcription start site {tss200} of cnksr1], cg09552548 [intergenic], and cg14789911 [body of spatc1l]), qPCR and digital PCR, whole blood, algorithm reported as a 4-tiered risk score for a 3-year risk of symptomatic CHD 9/19/2024 Presente
0440U Cardiology (coronary heart disease [CHD]), DNA, analysis of 10 single-nucleotide polymorphisms (SNPs) (rs710987 [LINC010019], rs1333048 [CDKN2B-AS1], rs12129789 [KCND3], rs942317 [KTN1-AS1], rs1441433 [PPP3CA], rs2869675 [PREX1], rs4639796 [ZBTB41], rs4376434 [LINC00972],rs12714414 [TMEM18], and rs7585056 [TMEM18]) and 6 DNA methylation markers (cg03725309 [SARS1], cg12586707 [CXCL1], cg04988978 [MPO], cg17901584 [DHCR24-DT], cg21161138 [AHRR], and cg12655112 [EHD4]), qPCR and digital PCR, whole blood, algorithm reported as detected or not detected for CHD 1/1/2025 Presente
0441U Infectious disease (bacterial, fungal, or viral infection), semiquantitative biomechanical assessment (via deformability cytometry), whole blood, with algorithmic analysis and result reported as an index 9/19/2024 Presente
0442U Infectious disease (respiratory infection), myxovirus resistance protein a (MXA) and c-reactive protein (CRP), fingerstick whole blood specimen, each biomarker reported as present or absent 9/19/2024 12/31/2024
0443U Neurofilament light chain (NfL), ultra-sensitive immunoassay, serum or cerebrospinal fluid 9/19/2024 Presente
0445U B-amyloid (abeta42) and phospho tau (181p) (ptau181), electrochemiluminescent immunoassay (ECLIA), cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology 9/19/2024 12/31/2024
0448U Oncology (lung and colon cancer), DNA, qualitative, next-generation sequencing detection of single-nucleotide variants and deletions in egfr and kras genes, formalin-fixed paraffin-embedded (FFPE) solid tumor samples, reported as presence or absence of targeted mutation(s), with recommended therapeutic options 9/19/2024 12/31/2024
0449U Carrier screening for severe inherited conditions (e.g., cystic fibrosis, spinal muscular atrophy, beta hemoglobinopathies [including sickle cell disease], alpha thalassemia), regardless of race or self-identified ancestry, genomic sequence analysis panel, must include analysis of 5 genes (cftr, smn1, hbb, hba1, hba2) 9/19/2024 12/31/2024
0450U Oncology (multiple myeloma), liquid chromatography with tandem mass spectrometry (LCMS/MS), monoclonal paraprotein sequencing analysis, serum, results reported as baseline presence or absence of detectable clonotypic peptides 9/19/2024 12/31/2024
0451U Oncology (multiple myeloma), LCMS/MS, peptide ion quantification, serum, results compared with baseline to determine monoclonal paraprotein abundance 9/19/2024 12/31/2024
0452U Oncology (bladder), methylated PENK DNA detection by linear target enrichment-quantitative methylation-specific real-time PCR (LTE-qMSP), urine, reported as likelihood of bladder cancer 9/19/2024 12/31/2024
0453U Oncology (colorectal cancer), cell-free DNA (cfDNA), methylation based quantitative PCR assay (SEPTIN9, IKZF1, BCAT1, Septin9-2, VAV3, BCAN), plasma, reported as presence or absence of circulating tumor DNA (ctDNA) 9/19/2024 12/31/2024
0454U Rare diseases (constitutional/heritable disorders), identification of copy number variations, inversions, insertions, translocations, and other structural variants by optical genome mapping 9/19/2024 12/31/2024
0455U Infectious agents (sexually transmitted infection), Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, multiplex amplified probe technique, vaginal, endocervical, gynecological specimens, oropharyngeal swabs, rectal swabs, female or male urine, each pathogen reported as detected or not detected 9/19/2024 12/31/2024
0456U Autoimmune (rheumatoid arthritis), next-generation sequencing (NGS), gene expression testing of 19 genes, whole blood, with analysis of anticyclic citrullinated peptides (CCP) levels, combined with sex, patient global assessment, and body mass index (BMI), algorithm reported as a score that predicts nonresponse to tumor necrosis factor inhibitor (TNFi) therapy 9/19/2024 12/31/2024
0459U β-amyloid (Abeta42) and total tau (tTau), electrochemiluminescent immunoassay (ECLIA), cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology 9/19/2024 12/31/2024
0460U Oncology, whole blood or buccal, DNA single-nucleotide polymorphism (SNP) genotyping by real-time PCR of 24 genes, with variant analysis and reported phenotypes 9/19/2024 Presente
0461U Oncology, pharmacogenomic analysis of single-nucleotide polymorphism (SNP) genotyping by real-time PCR of 24 genes, whole blood or buccal swab, with variant analysis, including impacted gene-drug interactions and reported phenotypes 9/19/2024 Presente
0464U Oncology (colorectal) screening, quantitative real-time target and signal amplification, methylated DNA markers, including LASS4, LRRC4 and PPP2R5C, a reference marker ZDHHC1, and a protein marker (fecal hemoglobin), utilizing stool, algorithm reported as a positive or negative result 9/19/2024 12/31/2024
0465U Oncology (urothelial carcinoma), DNA, quantitative methylation specific PCR of 2 genes (ONECUT2, VIM), algorithmic analysis reported as positive or negative 9/19/2024 12/31/2024
0466U Cardiology (coronary artery disease [CAD]), DNA, genome wide association studies (564856 single-nucleotide polymorphisms [SNPs], targeted variant genotyping), patient lifestyle and clinical data, buccal swab, algorithm reported as polygenic risk to acquired heart disease 9/19/2024 Presente
0467U Oncology (bladder), DNA, next-generation sequencing (NGS) of 60 genes and whole genome aneuploidy, urine, algorithms reported as minimal residual disease (MRD) status positive or negative and quantitative disease burden 9/19/2024 12/31/2024
0469U Rare diseases (constitutional/heritable disorders), whole genome sequence analysis for chromosomal abnormalities, copy number variants, duplications/deletions, inversions, unbalanced translocations, regions of homozygosity (ROH), inheritance pattern that indicate uniparental disomy (UPD), and aneuploidy, fetal sample (amniotic fluid, chorionic villus sample, or products of conception), identification and categorization of genetic variants, diagnostic report of fetal results based on phenotype with maternal sample and paternal sample, if performed, as comparators and/or maternal cell contamination 9/19/2024 12/31/2024
0471U Oncology (colorectal cancer), qualitative real-time PCR of 35 variants of KRAS and NRAS genes (exons 2, 3, 4), formalin-fixed paraffin-embedded (FFPE), predictive, identification of detected mutations 9/19/2024 12/31/2024
0472U Carbonic anhydrase VI (CA VI), parotid specific/secretory protein (PSP) and salivary protein (SP1) IgG, IgM, and IgA antibodies, enzyme-linked immunosorbent assay (ELISA), semiqualitative, blood, reported as predictive evidence of early Sjögren syndrome 9/19/2024 Presente
0474U Hereditary pan-cancer (e.g., hereditary sarcomas, hereditary endocrine tumors, hereditary neuroendocrine tumors, hereditary cutaneous melanoma), genomic sequence analysis panel of 88 genes with 20 duplications/deletions using next-generation sequencing (NGS), Sanger sequencing, blood or saliva, reported as positive or negative for germline variants, each gene 9/19/2024 12/31/2024
0475U Hereditary prostate cancer related disorders, genomic sequence analysis panel using next-generation sequencing (NGS), Sanger sequencing, multiplex ligation-dependent probe amplification (MLPA), and array comparative genomic hybridization (CGH), evaluation of 23 genes and duplications/deletions when indicated, pathologic mutations reported with a genetic risk score for prostate cancer 9/19/2024 12/31/2024
0476U Drug metabolism, psychiatry (e.g., major depressive disorder, general anxiety disorder, attention deficit hyperactivity disorder [ADHD], schizophrenia), whole blood, buccal swab, and pharmacogenomic genotyping of 14 genes and CYP2D6 copy number variant analysis and reported phenotypes 10/1/2024 12/31/2024
0477U Drug metabolism, psychiatry (e.g., major depressive disorder, general anxiety disorder, attention deficit hyperactivity disorder [ADHD], schizophrenia), whole blood, buccal swab, and pharmacogenomic genotyping of 14 genes and CYP2D6 copy number variant analysis, including impacted gene-drug interactions and reported phenotypes 10/1/2024 12/31/2024
0479U Tau, phosphorylated, pTau217 10/1/2024 12/31/2024
0486U Oncology (pan-solid tumor), next-generation sequencing analysis of tumor methylation markers present in cell-free circulating tumor DNA, algorithm reported as quantitative measurement of methylation as a correlate of tumor fraction 10/1/2024 Presente
0487U Oncology (solid tumor), cell-free circulating DNA, targeted genomic sequence analysis panel of 84 genes, interrogation for sequence variants, aneuploidy corrected gene copy number amplifications and losses, gene rearrangements, and microsatellite instability 10/1/2024 12/31/2024
0488U Obstetrics (fetal antigen noninvasive prenatal test), cell-free DNA sequence analysis for detection of fetal presence or absence of 1 or more of the Rh, C, c, D, E, Duffy (Fya), or Kell (K) antigen in alloimmunized pregnancies, reported as selected antigen(s) detected or not detected 10/1/2024 12/31/2024
0489U Obstetrics (single-gene noninvasive prenatal test), cell-free DNA sequence analysis of 1 or more targets (e.g., CFTR, SMN1, HBB, HBA1, HBA2) to identify paternally inherited pathogenic variants, and relative mutation-dosage analysis based on molecular counts to determine fetal inheritance of maternal mutation, algorithm reported as a fetal risk score for the condition (e.g., cystic fibrosis, spinal muscular atrophy, beta hemoglobinopathies [including sickle cell disease], alpha thalassemia) 10/1/2024 Presente
0493U Transplantation medicine, quantification of donor-derived cell-free DNA (cfDNA) using next-generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA 10/1/2024 12/31/2024
0495U Oncology (prostate), analysis of circulating plasma proteins (tPSA, fPSA, KLK2, PSP94, and GDF15), germline polygenic risk score (60 variants), clinical information (age, family history of prostate cancer, prior negative prostate biopsy), algorithm reported as risk of likelihood of detecting clinically significant prostate cancer 10/1/2024 12/31/2024
0496U Oncology (colorectal), cell-free DNA, 8 genes for mutations, 7 genes for methylation by real-time RT-PCR, and 4 proteins by enzyme-linked immunosorbent assay, blood, reported positive or negative for colorectal cancer or advanced adenoma risk 10/1/2024 Presente
0497U Oncology (prostate), mRNA gene expression profiling by real-time RT-PCR of 6 genes (FOXM1, MCM3, MTUS1, TTC21B, ALAS1, and PPP2CA), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a risk score for prostate cancer 10/1/2024 12/31/2024
0498U Oncology (colorectal), next-generation sequencing for mutation detection in 43 genes and methylation pattern in 45 genes, blood, and formalin-fixed paraffin-embedded (FFPE) tissue, report of variants and methylation pattern with interpretation 10/1/2024 Presente
0499U Oncology (colorectal and lung), DNA from formalin-fixed paraffin-embedded (FFPE) tissue, next-generation sequencing of 8 genes (NRAS, EGFR, CTNNB1, PIK3CA, APC, BRAF, KRAS, and TP53), mutation detection 10/1/2024 12/31/2024
0500U Autoinflammatory disease (VEXAS syndrome), DNA, UBA1 gene mutations, targeted variant analysis (M41T, M41V, M41L, c.118-2A>C, c.118-1G>C, c.1189_118-2del, S56F, S621C) 10/1/2024 12/31/2024
0501U Oncology (colorectal), blood, quantitative measurement of cell-free DNA (cfDNA) 10/1/2024 Presente
0502U Human papillomavirus (HPV), E6/E7 markers for high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), cervical cells, branched-chain capture hybridization, reported as negative or positive for high-risk for HPV 10/1/2024 12/31/2024
0503U Neurology (Alzheimer disease), beta amyloid (Aβ40, Aβ42, Aβ42/40 ratio) and tau-protein (ptau217, np-tau217, ptau217/nptau217 ratio), blood, immunoprecipitation with quantitation by liquid chromatography with tandem mass spectrometry (LC-MS/MS), algorithm score reported as likelihood of positive or negative for amyloid plaques 10/1/2024 12/31/2024
0504U Infectious disease (urinary tract infection), identification of 17 pathologic organisms, urine, real-time PCR, reported as positive or negative for each organism 10/1/2024 12/31/2024
0505U Infectious disease (vaginal infection), identification of 32 pathogenic organisms, swab, real-time PCR, reported as positive or negative for each organism 10/1/2024 12/31/2024
0506U Gastroenterology (Barrett’s esophagus), esophageal cells, DNA methylation analysis by next-generation sequencing of at least 89 differentially methylated genomic regions, algorithm reported as likelihood for Barrett’s esophagus 10/1/2024 12/31/2024
0507U Oncology (ovarian), DNA, whole genome sequencing with 5hydroxymethylcytosine (5hmC) enrichment, using whole blood or plasma, algorithm reported as cancer detected or not detected 10/1/2024 12/31/2024
0508U Transplantation medicine, quantification of donor-derived cell-free DNA using 40 single nucleotide polymorphisms (SNPs), plasma, and urine, initial evaluation reported as percentage of donor-derived cell-free DNA with risk for active rejection 10/1/2024 Presente
0509U Transplantation medicine, quantification of donor-derived cell-free DNA using up to 12 single-nucleotide polymorphisms (SNPs) previously identified, plasma, reported as percentage of donor-derived cell-free DNA with risk for active rejection 10/1/2024 Presente
0510U Oncology (pancreatic cancer), augmentative algorithmic analysis of 16 genes from previously sequenced RNA whole transcriptome data, reported as probability of predicted molecular subtype 10/1/2024 Presente
0511U Oncology (solid tumor), tumor cell culture in 3D microenvironment, 36 or more drug panel, reported as tumor-response prediction for each drug 10/1/2024 12/31/2024
0512U Oncology (prostate), augmentative algorithmic analysis of digitized whole-slide imaging of histologic features for microsatellite instability (MSI) status, formalin-fixed paraffin-embedded (FFPE) tissue, reported as increased or decreased probability of MSI-high (MSI-H) 10/1/2024 12/31/2024
0513U Oncology (prostate), augmentative algorithmic analysis of digitized whole-slide imaging of histologic features for microsatellite instability (MSI) and homologous recombination deficiency (HRD) status, formalin-fixed paraffin-embedded (FFPE) tissue, reported as increased or decreased probability of each biomarker 10/1/2024 12/31/2024
0514U Gastroenterology (irritable bowel disease [IBD]), immunoassay for quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, results reported as a numerical value as micrograms per milliliter (µg/mL) 10/1/2024 12/31/2024
0515U Gastroenterology (irritable bowel disease [IBD]), immunoassay for quantitative determination of infliximab (IFX) levels in venous serum in patients undergoing infliximab therapy, results reported as a numerical value as micrograms per milliliter (µg/mL) 10/1/2024 12/31/2024
0516U Drug metabolism, whole blood, pharmacogenomic genotyping of 40 genes and CYP2D6 copy number variant analysis, reported as metabolizer status 10/1/2024 12/31/2024
0517U Therapeutic drug monitoring, 80 or more psychoactive drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally and maximally effective dose of prescribed and non-prescribed medications 10/1/2024 12/31/2024
0518U Therapeutic drug monitoring, 90 or more pain and mental health drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally effective range of prescribed and non-prescribed medications 10/1/2024 12/31/2024
0519U Therapeutic drug monitoring, medications specific to pain, depression, and anxiety, LCMS/MS, plasma, 110 or more drugs or substances, qualitative and quantitative therapeutic minimally effective range of prescribed, non-prescribed, and illicit medications in circulation 10/1/2024 12/31/2024
0520U Therapeutic drug monitoring, 200 or more drugs or substances, LCMS/MS, plasma, qualitative and quantitative therapeutic minimally effective range of prescribed and non-prescribed medications 10/1/2024 12/31/2024
0521U Rheumatoid factor IGA and IGM, cyclic citrullinated peptide (CCP) antibodies, and scavenger receptor a (SR-A) by immunoassay, blood 1/1/2025 Presente
0522U Carbonic anhydrase vi, parotid specific/secretory protein and salivary protein 1 (sp1), IGG, IGM, and IGA antibodies, chemiluminescence, semiqualitative, blood 1/1/2025 Presente
0523U Oncology (solid tumor), DNA, qualitative, next-generation sequencing (NGS) of single-nucleotide variants (SNV) and insertion/deletions in 22 genes utilizing formalin-fixed paraffin-embedded tissue, reported as presence or absence of mutation(s), location of mutation(s), nucleotide change, and amino acid change 1/1/2025 Presente
0524U Obstetrics (preeclampsia), SFLT-1/PLGF ratio, immunoassay, utilizing serum or plasma, reported as a value 1/1/2025 Presente
0525U Oncology, spheroid cell culture, 11-drug panel (carboplatin, docetaxel, doxorubicin, etoposide, gemcitabine, niraparib, Olaparib, paclitaxel, rucaparib, topotecan, veliparib) ovarian, fallopian, or peritoneal response prediction for each drug 1/1/2025 Presente
0526U Nephrology (renal transplant), quantification of cxcl10 chemokines, flow cytometry, urine, reported as pg/ml creatinine baseline and monitoring over time 1/1/2025 Presente
0527U Herpes simplex virus (HSV) types 1 and 2 and varicella zoster virus (VZV), amplified probe technique, each pathogen reported as detected or not detected 1/1/2025 Presente
0528U Lower respiratory tract infectious agent detection, 18 bacteria, 8 viruses, and 7 antimicrobial-resistance genes, amplified probe technique, including reverse transcription for RNA targets, each analyte reported as detected or not detected with semiquantitative results for 15 bacteria 1/1/2025 Presente
0529U Hematology (venous thromboembolism [VTE]), genome-wide single-nucleotide polymorphism variants, including F2 and F5 gene analysis, and Leiden variant, by microarray analysis, saliva, report as risk score for VTE 1/1/2025 Presente
0530U Oncology (pan-solid tumor), ctDNA, utilizing plasma, next-generation sequencing (NGS) of 77 genes, 8 fusions, microsatellite instability, and tumor mutation burden, interpretative report for single-nucleotide variants, copy-number alterations, with therapy association 1/1/2025 Presente
0531U Infectious disease (acid-fast bacteria and invasive fungi), DNA (673 organisms), next-generation sequencing, plasma 4/1/2025 Presente
0532U Rare diseases (constitutional disease/hereditary disorders), rapid whole genome and mitochondrial DNA sequencing for single nucleotide variants, insertions/deletions, copy number variations, peripheral blood, buffy coat, saliva, buccal or tissue sample, results reported as positive or negative 4/1/2025 Presente
0533U Drug metabolism (adverse drug reactions and drug response), genotyping of 16 genes (i.e., ABCG2, CYP2B6, CYP2C9, CYP2C19, CYP2C, CYP2D6, CYP3A5, CYP4F2, DPYD, G6PD, GGCX, NUDT15, SLCO1B1, TPMT, UGT1A1, VKORC1), reported as metabolizer status and transporter function 4/1/2025 Presente
0534U Oncology (prostate), microRNA, single-nucleotide polymorphisms (SNPs) analysis by RT-PCR of 32 variants, using buccal swab algorithm reported as a risk score  4/1/2025 Presente
0536U Red blood cell antigen (fetal RhD), PCR analysis of exon 4 of RHD gene and housekeeping control gene GAPDH from whole blood in pregnant individuals at 10+ weeks gestation known to be RhD negative, reported as fetal RhD status 4/1/2025 Presente
0537U Oncology (colorectal cancer), analysis of cell-free DNA for epigenomic patterns, next-generation sequencing, >2500 differentially methylated regions (DMRs), plasma, algorithm reported as positive or negative 4/1/2025 Presente
0538U Oncology (solid tumor), next-generation targeted sequencing analysis, formalin-fixed paraffin-embedded (FFPE) tumor tissue, DNA analysis of 600 genes, interrogation for single-nucleotide variants, insertions/deletions, gene rearrangements, and copy number alterations, microsatellite instability, tumor mutation burden, reported as actionable variant 4/1/2025 Presente
0539U Oncology (solid tumor), cell-free circulating tumor DNA (ctDNA), 152 genes, next-generation sequencing, interrogation for single nucleotide variants, insertions/deletions, gene rearrangements, copy number alterations, and microsatellite instability, using whole-blood samples, mutations with clinical actionability reported as actionable variant 4/1/2025 Presente
0540U Transplantation medicine, quantification of donor derived cell-free DNA using next-generation sequencing analysis of plasma, reported as percentage of donor derived cell-free DNA to determine probability of rejection 4/1/2025 Presente
0542U Nephrology (renal transplant), urine, nuclear magnetic resonance (NMR) spectroscopy measurement of 84 urinary metabolites, combined with patient data, quantification of BK virus (human polyomavirus 1) using real-time PCR and serum creatinine, algorithm reported as a probability score for allograft injury status 4/1/2025 Presente
0543U Oncology (solid tumor), next-generation sequencing of DNA from formalin-fixed paraffin-embedded (FFPE) tissue of 517 genes, interrogation for single nucleotide variants, multi-nucleotide variants, insertions and deletions from DNA, fusions in 24 genes and splice variants in 1 gene from RNA, and tumor mutation burden  4/1/2025 Presente
0544U Nephrology (transplant monitoring), 48 variants by digital PCR, using cell-free DNA from plasma, donor derived cell-free DNA, percentage reported as risk for rejection  4/1/2025 Presente
0545U Acetylcholine receptor (AChR), antibody identification by immunofluorescence, using live cells, reported as positive or negative 4/1/2025 Presente
0546U Low-density lipoprotein receptor-related protein 4 (LRP4), antibody identification by immunofluorescence, using live cells, reported as positive or negative 4/1/2025 Presente
0549U Oncology (urothelial), DNA, quantitative methylated real-time PCR of TRNA-Cys, SIM2, and NKX1-1, using urine, diagnostic algorithm reported as a probability index for bladder cancer and/or upper tract urothelial carcinoma (UTUC) 4/1/2025 Presente
0551U Tau, phosphorylated, pTau217, by single-molecule array (ultrasensitive digital protein detection), using plasma 4/1/2025 Presente
0552U Reproductive medicine (preimplantation genetic assessment), analysis for known genetic disorders from trophectoderm biopsy, linkage analysis of disease-causing locus, and when possible, targeted mutation analysis for known familial variant, reported as low-risk or high-risk for familial genetic disorder  7/1/2025 Presente
0553U Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from embryonic trophectoderm for structural rearrangements, aneuploidy, and a mitochondrial DNA score, results reported as normal/balanced (euploidy/balanced), unbalanced structural rearrangement, monosomy, trisomy, segmental aneuploidy, or mosaic, per embryo tested  7/1/2025 Presente
0554U Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from trophectoderm biopsy for aneuploidy, ploidy, a mitochondrial DNA score, and embryo quality control, results reported as normal (euploidy), monosomy, trisomy, segmental aneuploidy, triploid, haploid, or mosaic, with quality control results reported as contamination detected or inconsistent cohort when applicable, per embryo tested  7/1/2025 Presente
0555U Reproductive medicine (preimplantation genetic assessment), analysis of 24 chromosomes using DNA genomic sequence analysis from embryonic trophectoderm for structural rearrangements, aneuploidy, ploidy, a mitochondrial DNA score, and embryo quality control, results reported as normal/balanced (euploidy/balanced), unbalanced structural rearrangement, monosomy, trisomy, segmental aneuploidy, triploid, haploid, or mosaic, with quality control results reported as contamination detected or inconsistent cohort when applicable, per embryo tested 7/1/2025 Presente
0556U Infectious disease (bacterial or viral respiratory tract infection), pathogen-specific DNA and RNA by real-time PCR, 12 targets, nasopharyngeal or oropharyngeal swab, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected  7/1/2025 Presente
0557U Infectious disease (bacterial vaginosis and vaginitis), realtime amplification of DNA markers for Atopobium vaginae, Gardnerella vaginalis, Megasphaera types 1 and 2, bacterial vaginosis associated bacteria-2 and -3 (BVAB-2, BVAB-3), Mobiluncus species, Trichomonas vaginalis, Neisseria gonorrhoeae, Candida species (C. albicans, C. tropicalis, C. parapsilosis, C. glabrata, C. krusei), Herpes simplex viruses 1 and 2, vaginal fluid, reported as detected or not detected for each organism  7/1/2025 Presente
0558U Oncology (colorectal), quantitative enzyme-linked immunosorbent assay (ELISA) for secreted colorectal cancer protein marker (BF7 antigen), using serum, result reported as indicative of response/no response to therapy or disease progression/regression  7/1/2025 Presente
0559U Oncology (breast), quantitative enzyme-linked immunosorbent assay (ELISA) for secreted breast cancer protein marker (BF9 antigen), serum, result reported as indicative of response/no response to therapy or disease progression/regression  7/1/2025 Presente
0563U Infectious disease (bacterial and/or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 11 viral targets and 4 bacterial targets, qualitative RT-PCR, upper respiratory specimen, each pathogen  7/1/2025 Presente
0564U Infectious disease (bacterial and/or viral respiratory tract infection), pathogen-specific nucleic acid (DNA or RNA), 10 viral targets and 4 bacterial targets, qualitative RT-PCR, upper respiratory specimen, each pathogen reported as positive or negative  7/1/2025 Presente
0565U Oncology (hepatocellular carcinoma), next-generation sequencing methylation pattern assay to detect 6626 epigenetic alterations, cellfree DNA, plasma, algorithm reported as cancer signal detected or not detected  7/1/2025 Presente
0566U Oncology (lung), qPCRbased analysis of 13 differentially methylated regions (CCDC181, HOXA7, LRRC8A, MARCHF11, MIR129-2, NCOR2, PANTR1, PRKCB, SLC9A3, TBR1_2, TRAP1, VWC2, ZNF781), pleural fluid, algorithm reported as a qualitative result  7/1/2025 Presente
0567U 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 genes, methylation status of selected regions, blood, saliva, amniocentesis, chorionic villus sample or tissue, identification and categorization of genetic variants  7/1/2025 Presente
0568U Neurology (dementia), beta amyloid (Aβ40, Aβ42, Aβ42/40 ratio), tau-protein phosphorylated at residue (eg, pTau217), neurofilament light chain (NfL), and glial fibrillary acidic protein (GFAP), by ultra-high sensitivity molecule array detection, plasma, algorithm reported as positive, intermediate, or negative for Alzheimer pathology  7/1/2025 Presente
0569U Oncology (solid tumor), next generation sequencing analysis of tumor methylation markers (>20000 differentially methylated regions) present in cell-free circulating tumor DNA (ctDNA), whole blood, algorithm reported as presence or absence of ctDNA with tumor fraction, if appropriate  7/1/2025 Presente
0571U Oncology (solid tumor), DNA (80 genes) and RNA (10 genes), by next-generation sequencing, plasma, including single-nucleotide variants, insertions/deletions, copy-number alterations, microsatellite instability, and fusions, reported as clinically actionable variants  7/1/2025 Presente
0572U Oncology (prostate), highthroughput telomere length quantification by FISH, whole blood, diagnostic algorithm reported as risk of prostate cancer  7/1/2025 Presente
0573U Oncology (pancreas), 3 biomarkers (glucose, carcinoembryonic antigen, and gastricsin), pancreatic cyst lesion fluid, algorithm reported as categorical mucinous or non-mucinous  7/1/2025 Presente