OneOme offers its RightMed® Test in all U.S. states and its RightMed® Comprehensive Test in select international locations. Please Contact us for more information on availability within your area.

OneOme has the following clinical laboratory certifications:

Clinical Laboratory Improvement Amendments (CLIA) Certificate of Accreditation

Number: 24D2109855

Expiration Date: 10/25/2020

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College of American Pathologists (CAP) Accreditation

Number: 9432670

Expiration Date: 10/03/2022

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State of Rhode Island License

Number: LCO01057

Expiration Date: 12/30/2020

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State of Maryland License

Number: 2580

Expiration Date: Non-expiring

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State of Pennsylvania

Number: 35305

Expiration Date: 08/15/2021

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State of California

Number: CDS-00800741

Expiration Date: 2/25/2021

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State of New York

Number: PFI: 9226

Expiration Date: 6/30/2021

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Other

OneOme NPI number: 1669836227

OneOme Tax Identification Number: 46-4356584

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Indications for use

The RightMed Test is prescription use only. The RightMed Test is a qualitative genotyping assessment system applied to genomic DNA isolated from human saliva collected using the OraCollect Dx OCD-100 to simultaneously detect, report, and interpret genetic variants in a broad multigene test. The interpretation of genomic data is intended to inform healthcare providers of pharmacogenomic associations which are categorized by Level of Concern and Level of Evidence. The RightMed Test describes the detected genotypes associated with metabolism, transport, or other physiological mechanisms by which some therapeutics interact with the body, but does not predict whether a person will or will not respond to, or experience adverse events with, a particular therapeutic.

The RightMed Test reports are indicated for reporting certain variants in the following genes: CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP4F2, CYP3A4, CYP3A5, F2, F5, TPMT, DPYD, NUDT15, VKORC1, SLCO1B1, COMT, DRD2, COMT, HTR2A, HTR2C, IFNL4, UGT1A1, GRIK4, HLA-A, HLA-B, OPRM1, SLC6A4, CYP2C Cluster

RightMed Test results are not a substitute for medical advice and should only be used in consultation with a medical professional. The RightMed Test does not determine the best medication for the patient; it is intended to inform healthcare providers of pharmacogenetic information and professional guidelines associated with the detected genotypes and predicted phenotypes. Information included is based upon scientific literature and does not take into account other genetic variants and environmental or social factors that may impact each patient. Other factors include, but are not limited to, environmental factors (e.g., smoking), health factors (e.g., diet), social and familial factors, various medical conditions, and drug-to-drug interactions. Administration of any medication requires careful therapeutic monitoring regardless of the phenotype or genotype-derived interaction reported. As a matter of practice, OneOme will routinely update its pharmacogenomic database as new information becomes available to the scientific community. Clinical annotations, including phenotype summaries, are therefore dependent on the date of generation and/or the database version used to generate that report.