| PLA Code |
Description |
Test Name |
Lab Name |
Manufacturer |
Effective Date |
|
XXXXX
|
RXX XXXXX XXXX XXXXXXX XXXXXX, DNA, XXXXX XXXXXXXXXXX XXXXXXX XXXX XXXXXXXX XX 35 XXXXXXXX XXXX 11 XXXXX XXXXXX, XXXXXXXXX XXXXX XXXXX, XXXXXX RBC XXXXXXX XXXXXXXX
|
PreciseType® HEA Test
|
|
Immucor, Inc
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXXXXXXX), XXXXXXXXXXXX XXXXXXXXXX XX XXXXX XXXXX XXXXXXXXXXX (XXXXXXXX XXXX, XXXXXXXX XXXX XXX XXXXXXXXX) XX XXXXXX XXXXXXXXXXXXXX XXXX XXXXXX XXXX XXXXXXXXXXXX (LC-MS/MS) XXXXX XXXXXXXX XXXXXXXX XXXXXXXXXX XXXXXXXXXXX, XXXXXXXXX XXXXXXXX XX XXXXXXXXXX XX XXXXXXXXXXX XXXXXX
|
PolypDX™
|
Atlantic Diagnostic Laboratories, LLC
|
Metabolomic Technologies Inc
|
11/30/2016
|
|
XXXXX
|
OXXXXXXXX (XXXXXXX) XXXXXXXXXXX XXXXXX XX XXXX XXXXXXXX (XXXXXXXXXXXXXX A-1, CA 125 II, XXXXXXXX XXXXXXXXXXX XXXXXXX, XXXXX XXXXXXXXXX XXXXXXX 4, XXXXXXXXXXX), XXXXXXXXX XXXXX, XXXXXXXXX XXXXXXXX XX X XXXXXXXXXX XXXXX
|
Overa (OVA1 Next Generation)
|
Aspira Labs, Inc
|
Vermillion, Inc
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXXXXX) XXXX XXXXXXXXXX XXXXXXX XX XXXX-XXXX RT-PCR XX 3 XXXXX (ERG, PCA3, XXX SPDEF), XXXXX, XXXXXXXXX XXXXXXXX XX XXXX XXXXX
|
ExosomeDx® Prostate(IntelliScore)
|
Exosome Diagnostics, Inc
|
Exosome Diagnostics, Inc
|
11/30/2016
|
|
XXXXX
|
DXXXXXXXX XX XXXXXXXXXXX XXXXXXXXXXX, XXXXXXXXXX, XXXXXXXXXXX XXX XXXXX, 120 XX XXXX XXXXXXXX, XXXXXXXXXX XXXXXXXXXXXXXX XXXX XXXX XXXXXXXXXXXX, XXXXX, XXXXXXXXXXX XXX XXXXXXXX XX XXXX XXXXXXXXXXX XXXXXXXXXX, XXX XXXX XX XXXXXXX
|
Drug-drug, Drug-substance Identification and Interaction
|
Aegis Sciences Corporation
|
Drug-drug, Drug-substance Identification and Interaction
|
11/30/2017
|
|
XXXXX
|
DXXX XXXX(X), XXXXXXXXXXX, XXXX XXXXXXXXXX XXXXXXXXXXXX XX XXXXXXXX XXXXXXX, XXX XXXXXX XX XXXX XXXXXXX, XXXXX, XXXXXXXX XXXXXXXX XXXXXXXXXXXX XXXXXXXXX DNA XXXXXXXXXXXXXX XX XXXXXXXXXX XX XXXXXX DNA, XXX XXXX XX XXXXXXX
|
ToxProtect
|
Genotox Laboratories LTD
|
Genotox Laboratories LTD
|
11/30/2016
|
|
XXXXX
|
HXXXXXXXXXXX XXXXXX XXXXXXXXX XXX XXXXXXXXXX XXXXXXXXXX, DNA, 16S XXX 23S XRNA, XXXA, XXX1, XXXA XXX XXXB, XXXX XXXXXXXXXX XXXXXXXXXX, XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XX XXXXX XXXXXX XX XXXXX XXXXXX, XXXXXXXXXX, XXXXXXXX XX XXXXXXXX XX XXXXXXXX XXX XXXXXXXXXX XX XXXXXXXXXXXXXX, XXXXXXXXXXXXXXXX, XXXXXXXXXXXXX, XXXXXXXXXXX, XXXXXXXXXXXX, XXX XXXXXXXXX
|
AmHPR H. Antibiotic Resistance Next Generation Sequencing Panel
|
American Molecuclar Laboratories, Inc
|
American Molecuclar Laboratories, Inc
|
11/30/2018
|
|
XXXXX
|
OXXXXXXX (XXXXXX XXXXXX), ERBB2 (HER2) XXXX XXXXXX XX FISH, XXXXX XXXXX XXXX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX XXXXXXXX XXXXX XXXXX-XXXXX XXXXXXXXXXXXXXXXX (DEP) XXXXXXX, XXXXXXXX XX ERBB2 XXXX XXXXXXXXX XX XXX-XXXXXXXXX
|
DEPArray™ HER2
|
PacificDx
|
PacificDx
|
11/30/2016
|
|
XXXXX
|
IXXXXXXXXX XXXXXXX (XXXXXXXXX), XXXXXX XXXXXX XX XXXXX XXXXXX XXXXXXXXXX, XXXXXXXXXXXX-XXXXX XXXXXX XX XXXXXX XXXXXXXXXXX, XXX XXXXXXXXX XXXXXXX
|
Bacterial Strain Typing by Whole Genome Sequencing
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
XXXXX
|
PXXXXXXXXXXX XXXX XXXXXXXXXX, XXXXXXXXXX XX XXXXX XXXXXXX XX LC-MS/MS, XXXXX XXXX XXXXX, XXXXXXXX XX X XXXXXXXXXX XX XX XXXXXXXXX XXXXXX-XXXXX XXXXX, XXX XXXX XX XXXXXXX XXXXXXXXX XXX XXXX XXXXXXXXX XXX XXXXXXXXXXX
|
Cordant CORE™
|
Cordant Health Solutions
|
Cordant Health Solutions
|
11/30/2016
|
|
XXXXX
|
GXXXXXXX XXXXXXXXX, XXXX XXXXXXXXXXXXX XXXXXXXXX XX XXXXX XXXXXX XXXX-XXXXXXXXXX XXXXXXXXXX, DNA, XXXXX XXXXX, XXXXXX XX XXXXXXXX XXXX XXXXXXXXXXXXX(X)
|
MatePair Targeted Rearrangements, Congenital
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXX XXXXX XXXXXXXXX), XXXX XXXXXXXXXXXXX XXXXXXXXX XX XXXXX XXXXXX XXXX-XXXXXXXXXX XXXXXXXXXX, DNA, XXXXX XX XXXXXX XXXXXX XX XXXXX, XXXXXX XX XXXXXXXX XXXX XXXXXXXXXXXXX(X)
|
MatePair Targeted Rearrangements, Oncology
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
XXXXX
|
HXXXXXXXXX (XXXXXXXXXXXXXX XXXXXXXXX), XXXX XXXXXXXXXXXXX XXXXXXXXX XX XXXXX XXXXXX XXXX-XXXXXXXXXX XXXXXXXXXX, DNA, XXXXX XXXXX XX XXXX XXXXXX, XXXXXX XX XXXXXXXX XXXX XXXXXXXXXXXXX(X)
|
MatePair Targeted Rearrangements, Hematologic
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXXXXXXXXXXX XXXXXXXXX), RNA, BCR/ABL1 XXXXX XXX XXXXX XXXXXXXXXX XXXXXX XXXXXXXXXXX, XXXXXXXXXXXX PCR XXXXXXXXXXXXX, XXXXX XX XXXX XXXXXX, XXXXXX XX XXXXXX XXX XXXXXXXX XX XXXXXXXX XXXX XXXXXXXXXXXX
|
BCR-ABL1 major and minor breakpoint fusion transcripts
|
University of Iowa, Department of Pathology
|
Asuragen
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXXXXXXXXXXX XXXXXXXXX), JAK2 XXXXXXXX, DNA, PCR XXXXXXXXXXXXX XX XXXXX 12-14 XXX XXXXXXXX XXXXXXXX, XXXXX XX XXXX XXXXXX, XXXXXX XX JAK2 XXXXXXXX XXX XXXXXXXX XX XXXXXXXX
|
JAK2 Mutation
|
University of Iowa, Department of Pathology
|
University of Iowa, Department of Pathology
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXXXX), XXXXXRNA XXXXXXXXX XX RT-PCR XX 10 XXXXXRNA XXXXXXXXX, XXXXXXXXX XXXX XXXXXX XXXXXXXX, XXXXXXXXX XXXXXXXX XX X XXXXXXXX XX XXXXXXXX XXXXXX XXX XXXXXXXX XX XXXX XXXX XX XXXXXXXXXX
|
ThyraMIR
|
Interpace Diagnostics
|
Interpace Diagnostics
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX, RNA, XXXX XXXXXXXXXX XX XXXXX XXXXXXXXXXXXX XXXXXXXXXX, XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX XX XXXXX XXXXXX XXXXXX, XXXXXXXXXX XXXXXXXXX XXXXXXXX XX XXXXXXXXX XXXXXXX XXX XXXXXXXXXXX XXXXXX
|
OncoTarget/OncoTreat
|
Columbia University Department of Pathology and Cell Biology
|
Darwin Health
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXXXXX), XXXXXXXXX XX 8 XXXXXXXXXXXXXX (ARF 6, NKX3-1, 5’-UTR-BMI1, CEP 164, 3’-UTR-RXXXXXXX, DXXXXXXXXXX, AURKAIP-1, CSNK2A2), XXXXXXXXXXX XXXXXXXXXXX XXX XXXX XXXXXXXXX XXXXX, XXXXXXXXX XXXXXXXX XX XXXX XXXXX
|
Apifiny®
|
Armune BioScience
|
Armune BioScience Inc
|
11/30/2016
|
|
XXXXX
|
TXXXXXXX XXXXXXX XXXXXXXX XXXXXXXX XXXXX, XXX-XXXXX XXXX XXXX XXXXXXXXX, DNA XXX RNA XXXXXXXX, 23 XXXXX, XXXXXXXXXXXXX XXX XXXXXXXX XXXXXXXX XXX XXXXXXXXXXXXXX, XXXXXXXX XX XXXXXXXX/XXXXXXX XX XXXXXXXX XXX XXXXXXXXXX XXXXXXX(XXX) XX XXXXXXXX
|
Oncomine™ Dx Target Test
|
Thermo Fisher Scientific
|
Thermo Fisher Scientific
|
11/30/2016
|
|
XXXXX
|
OXXXXXXX (XXXXX XXXXXXXXXXX XXXXXXXX), DNA, XXXXXXXXXX XX XXXXXXXX XXXXXX XXXXXXXXXXX, X.D835, X.I836, XXXXX XXXXXXXXXXX XXXXX, XXXXXXXX XX XXXXXXXXX XX XXX-XXXXXXXXX XX FLT3 XXXXXXXX XXX XXXXXXXXXX XXX XX XXXXXXX XXX XXX XX XXXXXXXXXXX
|
LeukoStrat® CDx FLT3 Mutation Assay
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
Invivoscribe Technologies, Inc
|
11/30/2016
|
|
XXXXX
|
GXXXXXXXXXXX XXXXX XXXXX XXXXXXXX (GXXXA), XXXXXXX XXXXXXXX XXXXXXXXX XXXXXXXXXXXX, XXXXXXXXXXXX
|
GlycA
|
Laboratory Corporation of America
|
Laboratory Corporation of America
|
11/30/2017
|
|
XXXXX
|
TXXXXXXXX, XX XXXXXX XXXXXXXXXXXXXX XXXX XXXXXX XXXX XXXXXXXXXXXX (LC-MS/MS), XXXXX, XXXXXXXXXXXX
|
UrSure Tenofovir Quantification Test
|
Synergy Medical Laboratories
|
UrSure Inc
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXXXX), DNA XXX XRNA XX 112 XXXXX, XXXX-XXXXXXXXXX XXXXXXXXXX, XXXX XXXXXX XXXXXXXX XX XXXXXXX XXXXXX, XXXXXXXXXXX XXXXXXXX XXXXXXXX XX X XXXXXXXXXXX XXXXXX ("PXXXXXXX, XXXX XXXXXXXXXXX XX XXXXXXXXXX" XX "NXXXXXXX, XXX XXXXXXXXXXX XX XXXXXXXXXX")
|
Thyroseq Genomic Classifier
|
CBLPath, Inc
|
University of Pittsburgh Medical Center
|
11/30/2017
|
|
XXXXX
|
JAK2 (JXXXX XXXXXX 2) (XX, XXXXXXXXXXXXXXXXXX XXXXXXXX) XXXX XXXXXXXX, XXXXXXXX XXXXXXXX XXXXXXXX XXXXX 12-15
|
JAK2 Exons 12 to 15 Sequencing
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
DXXX XXXXXXXXXX (XXXXXXX XXXX XXXXXXXXX XXX XXXX XXXXXXXX), XXXXXXXX XXXXXXXX XXXXXXXX (XX, CYP1A2, CYP2C19, CYP2C9, CYP2D6, CYP3A4, CYP3A5, CYP4F2, SLCO1B1, VKORC1 XXX XX12777823)
|
Focused Pharmacogenomics Panel
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
DXXX XXXXXXXXXX (XXXXXXXX XXXX XXXXXXXX), XXXXXXXX XXXXXXXX XXXXXXXX (XX, CYP2C9, CYP4F2, VKORC1, XX12777823)
|
Warfarin Response Genotype
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
CYP1A2 (XXXXXXXXXX P450 XXXXXX 1, XXXXXXXXX A, XXXXXX 2) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXX XXXXXXXX (XX, *1F, *1K, *6, *7)
|
Cytochrome P450 1A2 Genotype
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
COMT (XXXXXXXX-O-XXXXXXXXXXXXXXXXX) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, X.472G>A (XX4680) XXXXXXX
|
Catechol-O-Methyltransferase (COMT) Genotype
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
HTR2A (5-XXXXXXXXXXXXXXXXX XXXXXXXX 2A), HTR2C (5-XXXXXXXXXXXXXXXXX XXXXXXXX 2C) (XX, XXXXXXXXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXX XXXXXXXX (XX, HTR2A XX7997012 [X.614-2211T>C], HTR2C XX3813929 [X.-759C>T] XXX XX1414334 [X.551-3008C>G])
|
Serotonin Receptor Genotype (HTR2A and HTR2C)
|
Mayo Clinic
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
TPMT (XXXXXXXXXX S-XXXXXXXXXXXXXXXXX), NUDT15 (XXXXX XXXXXXXXXXX 15) (XX, XXXXXXXXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXX XXXXXXXX (XX, 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
|
|
XXXXX
|
NXXXXXXXX (XXXXX XXXXXXX), XXXXXXXXXXXXX XXXXX, XXXXXXXXX XX XXXXX XXXXXXX XX XXXXXXX-XXXXXXX XXXXXXXXXXXXXX XXXXXXXXXX, XXXXXXXXXXX
|
Real-time quaking-induced conversion for prion detection (RT-QuIC)
|
National Prion Disease Pathology Surveillance Center
|
|
11/30/2017
|
|
XXXXX
|
EXXXX (XX, XXXXXXX XXXXXXXXX), XXXXXX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXX XXXXXX XXX XXXXXX XXXXXXXX, XXXXXXXX XXXXXXXX
|
EXaCT-1 Whole Exome Testing
|
Lab of Oncology-Molecular Detection
|
Weill Cornell Medicine-Clinical Genomics Laboratory
|
11/30/2017
|
|
XXXXX
|
TXXXXXXX XXXXXXX XXXXXXXX XXXXXXXX, XXXXX XXXXX XXXXXXXX, DNA XXXXXXXX XX 324 XXXXX, XXXXXXXXXXXXX XXX XXXXXXXX XXXXXXXX, XXXX XXXX XXXXXX XXXXXXXXXXXXXX, XXXX XXXXXXXXXXXXXX, XXXXXXXXXXXXXX XXXXXXXXXXX XXX XXXXX XXXXXXXXXX XXXXXX
|
FoundationOne CDx™ (F1CDx)
|
Foundation Medicine, Inc
|
Foundation Medicine, Inc
|
11/30/2017
|
|
XXXXX
|
VXXXXXX D, 25 XXXXXXX D2 XXX D3, XX LC-MS/MS, XXXXX XXXXXXXXXXX, XXXXXXXXXXXX
|
Sensieva™ Droplet 25OH Vitamin D2/D3 Microvolume LC/MS Assay
|
InSource Diagnostics
|
|
11/30/2017
|
|
XXXXX
|
DXXXXXXXXXXXXXXX XXXX (DNA) XXXXXXXX, XXXXXX XXXXXXXX, XXXX XXXXXXX
|
Anti-dsDNA, High Salt/Avidity
|
University of Washington, Department of Laboratory Medicine
|
Bio-Rad
|
11/30/2017
|
|
XXXXX
|
BCR/ABL1 (X(9;22)) (XX, XXXXXXX XXXXXXXXXXX XXXXXXXX) XXXXXXXXXXXXX XXXXXXXX, XXXXX XXXXXXXXXX, XXXXXXXXXXXX
|
MRDx BCR-ABL Test
|
MolecularMD
|
MolecularMD
|
11/30/2017
|
|
XXXXX
|
BXXXXXXX XXXXXXXXXXX, XXXXXXXX XXXXXXXXX XX 5 XXXXXXXXXXX XXXXXXX XXXXXX, XX XXXXXXXXXX, IXM
|
Lyme ImmunoBlot IgM
|
IGeneX Inc
|
ID-FISH Technology Inc (ASR) (Lyme ImmunoBlot IgM Strips Only)
|
11/30/2017
|
|
XXXXX
|
BXXXXXXX XXXXXXXXXXX, XXXXXXXX XXXXXXXXX XX 12 XXXXXXXXXXX XXXXXXX XXXXXX, XX XXXXXXXXXX, IXG
|
Lyme ImmunoBlots IgG
|
IGeneX Inc
|
ID-FISH Technology Inc (ASR) (Lyme ImmunoBlot IgG Strips Only)
|
11/30/2017
|
|
XXXXX
|
TXXX-XXXXX XXXXXXXXX XXXXX BXXXXXXX XXXXX, XXXXXXXX XXXXXXXXX XX 4 XXXXXXXXXXX XXXXXXX XXXXXX, XX XXXXXXXXXX, IXM
|
Tick-Borne Relapsing Fever Borrelia (TBRF) ImmunoBlots IgM Test
|
IGeneX Inc
|
ID-FISH Technology Inc (Provides TBRF ImmunoBlot IgM Strips)
|
11/30/2017
|
|
XXXXX
|
TXXX-XXXXX XXXXXXXXX XXXXX BXXXXXXX XXXXX, XXXXXXXX XXXXXXXXX XX 4 XXXXXXXXXXX XXXXXXX XXXXXX, XX XXXXXXXXXX, IXG
|
Tick-Borne Relapsing Fever Borrelia (TBRF) ImmunoBlots IgG Test
|
IGeneX Inc
|
ID-FISH Technology Inc (Provides TBRF ImmunoBlot IgG Strips)
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXXX XXXXXX XXXXXXXXX XX XXXX), XRNA, XXXX XXXXXXXXXX XXXXXXXXX XX XXXX-XXXX RT-PCR XX 12 XXXXX (7 XXXXXXX XXX 5 XXXXXXXXXXXX), XXXXXXXXX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX XXXXXXXXXX XXXXX
|
The Oncotype DX® Breast DCIS Score™ Test
|
Genomic Health, Inc
|
Genomic Health, Inc
|
11/30/2017
|
|
XXXXX
|
FLT3 (XXX-XXXXXXX XXXXXXXX XXXXXX 3) (XX, XXXXX XXXXXXX XXXXXXXX) XXXXXXXX XXXXXX XXXXXXXXXXX (ITD) XXXXXXXX, XXXXXXXXXXXX
|
FLT3 ITD MRD by NGS
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXXXXX), XRNA, XXXX XXXXXXXXXX XXXXXXXXX XX XXXX-XXXX RT-PCR XX 17 XXXXX (12 XXXXXXX XXX 5 XXXXXXXXXXXX), XXXXXXXXX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX X XXXX XXXXX
|
Oncotype DX Genomic Prostate Score
|
Genomic Health, Inc
|
Genomic Health, Inc
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXX XXXXX XXXXXXXXX), DNA, XXXXXXXX XXXXXXXXXX XX XXXXXXX-XXXXXX XXXXX XX 468 XXXXXX-XXXXXXXXXX XXXXX, XXXXXXXXX XXXXXXXXXXXXX XXX XXXXXXX XXXXXXXXX XXX XXXXXXXXXXXXXX XXXXXXXXXXX, XXXXXXX XXXX XXXXXX XXXXXXXXX, XXXXXXXXX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXX XXXXXX, XXXXXX XX XXXXXXXXXX XXXXXXXXXXX XXXXXXXX(X)
|
MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets)
|
Memorial Sloan Kettering Cancer Center
|
Memorial Sloan Kettering Cancer Center
|
11/30/2017
|
|
XXXXX
|
NPM1 (XXXXXXXXXXXXX) (XX, XXXXX XXXXXXX XXXXXXXX) XXXX XXXXXXXX, XXXXXXXXXXXX
|
NPM1 MRD by NGS
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
11/30/2017
|
|
XXXXX
|
TXXXXXXX XXXXXXX XXXXXXXX XXXXXXXX XXXXX, XXXXX XXXXXXXXXXX XXXXXXXX, DNA XXXXXXXX, 194 XXXXX, XXXXXXXXXXXXX XXX XXXXXXXX XXXXXXXX, XXXX XXXXXX XXXXXXXX XX XXXXXXXXXXXXXX
|
MyAML NGS Panel
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
LabPMM LLC, an Invivoscribe Technologies, Inc Company
|
11/30/2017
|
|
XXXXX
|
PXXXXXXXXXXX XXXX XXXXXXXXXX, XXXXXXXXXX XX XXXXX XXXXXXX XX LC-MS/MS, XXXXX, 31 XXXX XXXXX, XXXXXXXX XX XXXXXXXXXXXX XXXXXXX, XXXXXXXX XX XXX XXXXXXXX, XXX XXXX XX XXXXXXX
|
UCompliDx
|
Elite Medical Laboratory Solutions, LLC (LDT)
|
Elite Medical Laboratory Solutions, LLC
|
11/30/2017
|
|
XXXXX
|
LXXXXXXXXXX, XXXXX, XXXX XXXXXXXXXX XXXXXXXXXXXXX XXX XXXXXXXXXXXX XX XXXXXXXXXXXX, XXXXXXXXX XXX XXXX XXXXX XXXXXXXXXXX XXXXXXX XXX XXXXXXXXXX XX HDL, LDL, XXX VLDL XX XXXXXXXX XXXX XXXXXXX XXXXXXXXXXXXXXXXXXX
|
VAP Cholesterol Test
|
VAP Diagnostics Laboratory, Inc
|
VAP Diagnostics Laboratory, Inc
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXXXXX XXXXXX), FISH XXXXXXXX XX 4 XXXXX (ASAP1, HDAC9, CHD1 XXX PTEN), XXXXXX XXXXXX XXXXXXXX, XXXXXXXXX XXXXXXXX XX XXXXXXXXXXX XX XXXXXX XXXXX XXXXX
|
Prostate Cancer Risk Panel
|
Mayo Clinic, Laboratory Developed Test
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
PXXXXXXXXXXX XXXX XXXXXXXXXX, 14 XX XXXX XXXXXXX XX XXXXX XXX XXXXXXXXXX, XXXXXXXXXX XXXXXX XXXX XXXXXXXXXXXX XXXX XXXXXXXXXXXXXX, XXXXXXXXX XXXXX, XXXXXXXXXXXX XXXXXX XXXX XXXXXXXXXXX XXX XXXXX XXXXXX, XXXXXXXXX XXXXXX-XXXXX XXXXX XXX XXX XXXXXXXXXX XXXX XXXX XXXXXXXX, XXX XXXX XX XXXXXXX
|
AssuranceRx Micro Serum
|
Firstox Laboratories, LLC
|
Firstox Laboratories, LLC
|
11/30/2017
|
|
XXXXX
|
CXXXXXXXXX (XXXXX XXXXXXXXXX), XXXX-XXXX DNA, PCR XXXXX XX 96 DNA XXXXXX XXXXXXXXX (94 XXXXXX XXXXXXXXXX XXXXXXXXXXXX XXXXXXX XXX XXX XXXXXXX XXXXXXX), XXXXXX
|
myTAIHEART
|
TAI Diagnostics, Inc
|
TAI Diagnostics, Inc
|
11/30/2017
|
|
XXXXX
|
HXXXXXXXXX (XXXXX XXXXXXXXXXX XXXXXXXX), DNA, XXXXX XXXXXX XXXX-XXXXXXXXXX XXXXXXXXXX XX XXXXXX XXXX XXXXXXXXXXXXX(X), XXXXX XX XXXX XXXXXX, XXXXXX XX XXXXXXXX XXXX XXXXXXXXXXXXX(X)
|
MatePair Acute Myeloid Leukemia Panel
|
Mayo Clinic, Laboratory Developed Test
|
Mayo Clinic
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXX XXXXX XXXXXXXXX), XRNA, XXXX XXXXXXXXXX XXXXXXXXX XX XXXXXXXXX XXXXXXXX XXXXXXXXXX XXX XXXXXXXX XX 51 XXXXX, XXXXXXXXX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX X XXXXXXXXXX XXXXXXXXXX XXXX
|
RNA-Sequencing by NGS
|
OmniSeq, Inc, Life Technologies Corporation
|
OmniSeq, Inc, Life Technologies Corporation
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (MXXXXX XXXX XXXXXXXXX), XXXXXXXXX XX XXXXXXXXXX XX XXX MXXXXX XXXX XXXXXXX XXXXX XXXXXXXXXXX (XXXXX T XXXXXXX), XXXXX, XXXXXXXXXXXX
|
Merkel SmT Oncoprotein Antibody Titer
|
University of Washington, Department of Laboratory Medicine
|
University of Washington, Department of Laboratory Medicine
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (MXXXXX XXXX XXXXXXXXX), XXXXXXXXX XX XXXXXXXXXX XX XXX MXXXXX XXXX XXXXXXX XXXXX XXXXXX XXXXXXX (VP1), XXXXX, XXXXXXXX XX XXXXXXXX XX XXXXXXXX
|
Merkel Virus VP1 Capsid Antibody
|
University of Washington, Department of Laboratory Medicine
|
University of Washington, Department of Laboratory Medicine
|
11/30/2017
|
|
XXXXX
|
TXXX XXXXXXXX, XXXXXXX XXXXXXXX XXXXXXXX XXXXXXXX XX XXXXXXXXXX 2, XXXXX XXXXXXXXXXX XXXX-XXXX XXXXX DNA XX XXXXXXXX XXXXX
|
Twins Zygosity PLA
|
Natera, Inc
|
Natera, Inc
|
11/30/2017
|
|
XXXXX
|
TXXXXXXXXXXXXX XXXXXXXXXXX XX XXXX XXXXXXXXXX (XXXXXX XXXXXXXXXXX [SXO2], XXXXXXXXXXXXX [XXHXO2], XXXXXXXXXXXXXXX [XXHXR], XXXXXXXXX XXX XXXXXXXXX XXXXXX XXXXXXXXXX XXXXXXXXXXXXXX [XXHX1 XXX XXHX2]), XXXXX XXXXXXX XXXXXXXXX XXXXXX XXXXXXX (SFDI) XXX XXXXX-XXXXXXXX XXXXXXXX
|
Transcutaneous multispectral measurement of tissue oxygenation and hemoglobin using spatial frequency domain imaging (SFDI)
|
Modulated Imaging, Inc
|
Modulated Imaging, Inc
|
11/30/2017
|
|
XXXXX
|
AXXXXXXXXX (XXXXXXXX XXXXX XXXXXXXXXXXXX), IXG XXX IXM XXXXXXXX XX 80 XXXXXXXXXX, XXXXXXXXX XXXXX, XXXXXXXXX XXXXXXXX XXXX X XXXX XXXXX
|
SLE-key® Rule Out
|
Veracis Inc
|
Veracis Inc
|
11/30/2017
|
|
XXXXX
|
NXXXXXXXX (XXXXXX), 32 XXXXXX XX LC-MS/MS, XXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX XXXXXXXXX XXXXXXXXX XXXXXXXXXX XXXX XXXXXX XXXXXXXX XXXXXXXX
|
NPDX ASD ADM Panel I
|
Stemina Biomarker Discovery, Inc
|
Stemina Biomarker Discovery, Inc d/b/a NeuroPointDX
|
11/30/2017
|
|
XXXXX
|
AXXXXXXX, TXXXXXXXX XXXXXXXX, XXXXX XXX XXXXX XXXXXX XXXXXX (RPR), XXXXXXXXXXX, XXXXXXXXXXX
|
BioPlex 2200 Syphilis Total & RPR Assay
|
Bio-Rad Laboratories
|
Bio-Rad Laboratories
|
11/30/2017
|
|
XXXXX
|
SXXXXXXX XXXX, XXX-XXXXXXXXXX XXXXXXXX, XXXXXXXXXXX, XXXXXXXXXXX (RPR)
|
BioPlex 2200 RPR Assay
|
Bio-Rad Laboratories
|
Bio-Rad Laboratories
|
11/30/2017
|
|
XXXXX
|
PXXXXXXXX XXXXX-XXXXX XXXXXXXX-1 (PAMG-1), XXXXXXXXXXX XXXX XXXXXX XXXXXXX XXXXXXXXXXX, XXXXXXX-XXXXXXX XXXXX, XXXX XXXXXXXX
|
PartoSure™ Test
|
Parsagen Diagnostics, Inc
|
Parsagen Diagnostics, Inc, a QIAGEN Company
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXXX), XXXXXXXXXXXXXXXXXXXX, XXXXXXX XXXXXXXXXX XXXXXXXXX XX 4 XXXXXXXXXX (XXXXXX XXXXXXXXXXXXXXXXX-1 [MMP-1], XXXXXXXXXXXXXXXX XXXXXXX-XXXXXXX XXXX XXXXXXXX XXXXXXXX 6 [CEACAM6], XXXXXXXXXXXXXXXXXXXXXXXX [HYAL1], XXXXXX XXXXXXXXX XX XXXXXX XXXXXXX [HEC1]), XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXXXXXXXX XXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX XXXXXXXXX XXXX XXXXX
|
BBDRisk Dx™
|
Silbiotech, Inc
|
Silbiotech, Inc
|
11/30/2017
|
|
XXXXX
|
CXXXXXX XXXXXXX XXXXX (C. XXXXXXXX, C. XXXXXXXX, C. XXXXXXXXXXXX, C. XXXXXXX, C. XXXXXXXXXX, XXX C. XXXXX), XXXXXXXXX XXXXX XXXXXXXXX XXXX XXXXXXXXXXX XXXXXX XX XXX XXXXXXXX XX XXXXXXX XX XXXX XXXXXXX
|
MYCODART Dual Amplification Real Time PCR Panel for 6 Candida species
|
RealTime Laboratories, Inc
|
RealTime Laboratories, Inc
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXXXXXXXX), XXXXXRNA, RT-PCR XXXXXXXXXX XXXXXXXXX XX XXR-31-3X, XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX XX XXXXXXXXXX XXXXX
|
miR-31now™
|
GoPath Laboratories
|
GoPath Laboratories
|
11/30/2017
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXX XXX XXXXXX XXXX XXXXXXXX (XX, *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
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXX XXXX XXXXXXXX (LXXX XXXXXXXXXX XX XXXXXXXX XX XXXX XXX XXXXXXX XXXXXXXXX)
|
CYP2D6 Full Gene Sequencing
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXXXX XXXXXXXX XXXXXXXX (XX, CYP2D6-2D7 XXXXXX XXXX) (LXXX XXXXXXXXXX XX XXXXXXXX XX XXXX XXX XXXXXXX XXXXXXXXX)
|
CYP2D6-2D7 Hybrid Gene Targeted Sequence Analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXXXX XXXXXXXX XXXXXXXX (XX, CYP2D7-2D6 XXXXXX XXXX) (LXXX XXXXXXXXXX XX XXXXXXXX XX XXXX XXX XXXXXXX XXXXXXXXX)
|
CYP2D7-2D6 Hybrid Gene Targeted Sequence Analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXXXX XXXXXXXX XXXXXXXX (XX, XXX-XXXXXXXXXX XXXX XXXX XXXXXXXXXXX/XXXXXXXXXXXXXX XX XXXXX) (LXXX XXXXXXXXXX XX XXXXXXXX XX XXXX XXX XXXXXXX XXXXXXXXX)
|
CYP2D6 trans-duplication/multiplication non-duplicated gene targeted sequence analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXXXX XXXXXXXX XXXXXXXX (XX, 5’ XXXX XXXXXXXXXXX/XXXXXXXXXXXXXX) (LXXX XXXXXXXXXX XX XXXXXXXX XX XXXX XXX XXXXXXX XXXXXXXXX)
|
CYP2D6 5’ gene duplication/multiplication targeted sequence analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
CYP2D6 (XXXXXXXXXX P450, XXXXXX 2, XXXXXXXXX D, XXXXXXXXXXX 6) (XX, XXXX XXXXXXXXXX) XXXX XXXXXXXX, XXXXXXXX XXXXXXXX XXXXXXXX (XX, 3’ XXXX XXXXXXXXXXX/ XXXXXXXXXXXXXX) (LXXX XXXXXXXXXX XX XXXXXXXX XX XXXX XXX XXXXXXX XXXXXXXXX)
|
CYP2D6 3’ gene duplication/multiplication targeted sequence analysis
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
IXXXXXXXXXXXXX XXXXXXXXXXX (M-XXXXXXX), XXXXXXXXXXX, XXXXXXXXXXXXXXXXXXX XXX XXXX XXXXXXXXXXXX, XXXXX XX XXXXX, XXXXXXXXX XXXXXXX
|
M-Protein Detection and Isotyping by MALDI-TOF Mass Spectrometry
|
Mayo Clinic
|
Mayo Clinic Laboratory Developed Test
|
11/30/2017
|
|
XXXXX
|
PXXX XXXXXXXXXX (XXXXXX-XXX XXXXXXXX) XXXXXXXXXX XXXXX, 16 XXXXXX XXXXXXXX (XX, ABCB1, COMT, DAT1, DBH, DOR, DRD1, DRD2, DRD4, GABA, GAL, HTR2A, HTTLPR, MTHFR, MUOR, OPRK1, OPRM1), XXXXXX XXXX XX XXXXX XXXXXXXX XXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX XXXXXXXX XX XXXXXXXX XXXX XX XXXXXX-XXX XXXXXXXX
|
INFINITI® Neural Response Panel
|
PersonalizeDx Labs
|
AutoGenomics Inc
|
11/30/2017
|
|
XXXXX
|
CXXXXXXXXXX DNA XXXXXXXX XXXXX XXXXXXXX XXXXXXXX XXXXXX-XXXXXXXXXX XXXXXXXXXXXXX (SNPX), XXXXX XXX XXXXXX DNA, XXX XXXXXXXX XXXXXXXX XXXXXXXXXXXX
|
ToxLok™
|
InSource Diagnostics
|
InSource Diagnostics
|
11/30/2017
|
|
XXXXX
|
OXXXXXXX (XXXX), XXXX XXXXXXXXXXXXX XXXXXXXX XX XXXXXXXX-3-XXXXXXX XXXXXXX XXX XXXXXXXXX XXXXXXXX XXXXXXXX-XXXX XXXX 1 XXXXXXX M130, XXXX XXXX XXXXXXXX XXXX XXXXXXX (XXX, XXXXXXX XXXXXX, XXXXXX XXXXXXXX, XXXXXX-XXXXXXXXXXX XXXXXX XXX XXXXXX XXXXXXXX), XXXXXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX X XXXXXXXXXXX XXXXXXXXXXX XX XXXXXXXXXX
|
BDX-XL2, Biodesix®, Inc
|
Biodesix®, Inc
|
Biodesix®, Inc
|
11/30/2018
|
|
XXXXX
|
OXXXXXXX (XXXXX XXXXXXXX), XRNA, XXXX-XXXXXXXXXX XXXXXXXXX XX XXXX-XXXX RT-PCR XX 15 XXXXX (12 XXXXXXX XXX 3 XXXXXXXXXXXX XXXXX), XXXXXXXXX XXXX XXXXXX XXXXXXXX XX XXXXXXXX-XXXXX XXXXXXXX-XXXXXXXX XXXXXX, XXXXXXXXX XXXXXXXX XX XXXX XX XXXXXXXXXX
|
DecisionDx®-UM
|
Castle Biosciences, Inc
|
Castle Biosciences, Inc
|
11/30/2018
|
|
XXXXX
|
DXXX XXXX(X), XXXXXXXXXX, 90 XX XXXX XXXXX XX XXXXXXXXXX, XXXXXXXXXX XXXXXXXXXXXXXX XXXX XXXX XXXXXXXXXXXX, XXX XXXXXXXXXXX, XXX XXXXXX XX XXXX XXXXXXX, XX XXXXXXXXXX XXXXXXXXX XXXXXXXX (XXXXXXXXX XXXXXXXXXXX), XXXXX, XXXXXX XX XXXXXXXX XX XXXXXXX XX XXXX XXXX, XXXX XXXXXXXXXX XX XXXXXXXXX XXXX XXXXXXXXXXX XXX XXXXXXXX XX XXXXXXXXXXX XXXXXXXXXXXX XXX XXXX XX XXXXXXX
|
NextGen Precision™ Testing
|
Precision Diagnostics LBN Precision Toxicology, LLC
|
Precision Diagnostics LBN Precision Toxicology, LLC
|
11/30/2018
|
|
XXXXX
|
OXXXXXXX, XXXXXXXX XX XXXXXXXXXXXX XXXXX XXXXX XXXXXXXX XXXXXXXX XXXXXXXXXX, XXXXX XX XXXXXX XXXXXX, XXXXXXXX XX XXXXXXXXXX XX XXXXXXXXXXX XX XXXXXXXXXX XX XXXXX XX XXXX XXXXXXXXXXXX
|
Onco4D™
|
Animated Dynamics, Inc
|
Animated Dynamics, Inc
|
11/30/2018
|
