Author: Steve Wang

FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

Dec. 19, 2023 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health Today, the U.S. Food and Drug Administration approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). As part of […]

UroGen QUAD

INFINITI UroGen QUAD Assay  The INFINITI UroGen QUAD Assay is CE Marked. The INFINITI UroGen QUAD is designed to detect three microorganisms: The INFINITI UroGen QUAD utilizes the UroGen QUAD Intellipac, UroGen QUAD Amp Mix and the UroGen QUAD BioFilmChip Microarray. The INFINITI UroGen QUAD Assay is automated by the INFINITI Analyzer. Analytes Detected:  Ureaplasma […]

Candida Vaginitis QUAD

INFINITI Candida Vaginitis QUAD The INFINITI Candida Vaginitis QUAD is CE Marked. The INFINITI Candida Vaginitis QUAD is designed to detect five fungal species. The INFINITI Candida Vaginitis QUAD utilizes the Candida Vaginitis QUAD Intellipac®, Candida Vaginitis QUAD Amp Mix and the Candida Vaginitis QUAD BioFilmChip® Microarray. The INFINITI Candida Vaginitis QUAD is automated by the INFINITI/INFINITI […]

Resolve QUAD

INFINITI Resolve QUAD The INFINITI Resolve QUAD Assay is designed to identify 6 pathogens. The INFINITI Resolve QUAD Assay utilizes the Resolve QUAD Intellipac®, Resolve QUAD Amp Mix and Resolve QUAD BioFilmChip® Microarray.  The INFINITI Resolve QUAD Assay is automated by the INFINITI Analyzer.  The INFINITI Resolve QUAD Assay is for research use only. Not for use […]

Respiratory Bacterial Panel (RBP)

INFINITI® Respiratory Bacterial Panel(RBP) The INFINITI® RBP Assay is designed to detect 4 common respiratory bacteria. The INFINITI® RBP Assay utilizes the RBP Intellipac® (Primer Extension Mix), RBP Amp Mix and RBP BioFilmChip® Microarray. The INFINITI® RBP Assay is used with the INFINITI® PLUS Analyzer or the INFINTI® High Throughput System (HTS) The INFINITI® RBP Assay is for research […]

NeuR

INFINITI® NeuR Assay The INFINITI NeuR Assay is designed to detect 16 genetic variants. The INFINITI NeuR Assay utilizes the NeuR Intellipac® (Primer Extension Mix), NeuR Amp Mix and NeuR BioFilmChip® Microarray. The INFINITI NeuR Assay is used with the INFINITI® PLUS Analyzer or the INFINITI® High Throughput System (HTS). The INFINITI NeuR Assay is for research use only. Not […]

GUD QUAD

INFINITI® GUD QUAD Assay The INFINITI GUD QUAD Assay is designed to detect 4 microorganisms: Herpes Simplex Virus (HSV) 1, Herpes Simplex Virus (HSV) 2, Treponema pallidum (TP), an Haemophilus ducreyi (HD). The INFINITI GUD QUAD Assay utilizes the GUD QUAD Intellipac® (Primer Extension Mix), GUD QUAD Amp Mix and GUD QUAD BioFilmChip Microarray. The INFINITI GUD QUAD Assay is used with the INFINITI® PLUS Analyzer […]

GBS QUAD

INFINITI® GBS QUAD Assay The INFINITI GBS QUAD Assay is designed to detect Streptococcus agalactiae also known as Group B Streptococcus.  The INFINITI GBS QUAD Assay utilizes the GBS QUAD Intellipac® (Primer Extension Mix) GBS QUAD Amp Mix and GBS QUAD BioFilmChip® Microarray. The INFINITI GBS QUAD Assay is used with the INFINITI® PLUS Analyzer or the INFINITI® High Throughput System (HTS). The INFINITI GBS […]

HCV QUAD

INFINITI HCV QUAD The INFINITI® HCV QUAD is designed to detect 6 HCV genotypes – 1, 2, 3, 4, 5, 6 and subtypes 1 a and 1 b. The INFINITI® HCV QUAD utilizes the HCV QUAD Intellipac®, HCV QUAD Amp Mix and HCV QUAD BioFilmChip® Microarray. The INFINITI® HCV QUAD is automated on the INFINITI® platform and INFINITI® HTS. The INFINITI® HCV […]

Neural Transmitter Panel

Neural Transmitter Panel The INFINITI® Neural Transmitter (NeuT) Panel is designed to detect 5 genetic variants. The INFINITI® NeuT Panel utilizes the NeuT Intellipac®, NeuT Amp Mix and NeuT BioFilmChip® Microarray. The INFINITI® NeuT Panel is automated by the INFINITI® PLUS and INFINITI® HTS systems. The INFINITI® NeuT is available for Research Use Only. Not for use in diagnostic procedures. Analytes Detected:  […]

UroGen Plus QUAD

INFINITI UroGen Plus QUAD The INFINITI UroGen Plus QUAD Assay is designed to detect four microorganisms. The INFINITI UroGen Plus QUAD Assay utilizes the UroGen Plus QUAD Intellipac®, UroGen Plus QUAD Amp Mix and the UroGen Plus QUAD BioFilmChip® Microarray. The INFINITI UroGen Plus QUAD Assay is automated by the INFINITI Analyzer. The INFINITI UroGen Plus QUAD […]

STD-6 QUAD

INFINITI STD-6 QUAD The INFINITI STD-6 QUAD is designed to detect six microorganisms. The INFINITI STD-6 QUAD utilizes the STD-6 QUAD Intellipac®, STD-6 QUAD Amp Mix and the STD-6 QUAD BioFilmChip® Microarray. The INFINITI STD-6 QUAD is automated by the INFINITI Analyzer. The INFINITI STD-6 QUAD is for research use only. Not for use in diagnostic procedures. […]

NTM Panel (Nontuberculous Mycobacteria)

INFINITI NTM (Nontuberculous Mycobateria) The INFINITI NTM is designed for the detection of mycobacteria and the identification of 14 common nontuberculous species. The INFINITI NTM utilizes the NTM Intellipac®, NTM Amp Mix and the NTM BioFilmChip® Microarray. The INFINITI NTM is for research use only. Not for use in diagnostic procedures. Analytes Detected:  Mycobacterium Genus M. avium […]

MDR-TB

INFINITI MDR-TB The INFINITI MDR-TB is designed to detect Mycobacterium tuberculosis complex and  genotypes resistance to Rifampin, Isoniazid, and Pyrazinamide in a single assay. The INFINITI MDR-TB utilizes the MDR-TB Intellipac®, MDR-TB Amp Mix and MDR-TB BioFilmChip® Microarray. The INFINITI MDR-TB is automated by the INFINITI Analyzer. The INFINITI MDR-TB is for research use only. […]

Leuko QUAD

INFINITI Leuko Quad Assay         The INFINITI Leuko QUAD Assay is designed to detect the following microorganisms: Chlamydia trachomatis Neisseria gonorrhea Trichomonas vaginalis The INFINITI Leuko QUAD Assay utilizes the Leuko QUAD Intellipac, Leuko QUAD Amp Mix and the Leuko QUAD BioFilmChip Microarray. The INFINITI Leuko QUAD Assay is automated by the INFINITI Analyzer. The INFINITI […]

CT-NG QUAD

INFINITI CT-NG QUAD The INFINITI CT-NG QUAD assay is designed to detect two microorganisms: The INFINITI CT-NG QUAD assay is automated by the INFINITI Analyzer. The INFINITI CT-NG QUAD assay is for research use only. Not for use in diagnostic procedures. Analytes Detected:  Chlamydia trachomatis Neisseria gonorrhea Features:  Simultaneous Multiplexed Determination of two microorganisms. 4 individual […]

Candida Plus QUAD

INFINITI Candida Plus QUAD The INFINITI Candida Plus QUAD is designed to detect six fungal species. The INFINITI Candida Plus QUAD utilizes the Candida Plus QUAD Intellipac®, Candida Plus QUAD Amp Mix and the Candida Plus QUAD BioFilmChip® Microarray. The INFINITI Candida Plus QUAD is automated by the INFINITI Analyzer. The INFINITI Candida Plus QUAD is for research use only. Not for use in diagnostic procedures. […]

NAT-2

INFINITI NAT-2 The INFINITI NAT-2 (N-acetyl tranferase 2) Assay is designed to identify NAT-2 genetic variants.  The INFINITI NAT-2 Assay utilizes the NAT-2 Intellipac®, NAT-2 Amp Mix and NAT-2 BioFilmChip®Microarray. The INFINITI NAT-2 Assay is automated by the INFINITI Analyzer. The INFINITI NAT-2 Assay is for research use only. Not for use in diagnostic procedures. Analytes […]

EGFR

INFINITI EGFR The INFINITI EGFR Assay is designed to identify EGFR genetic mutations. The INFINITI EGFR Assay utilizes the EGFR Intellipac®, EGFR Amp Mix and EGFR BioFilmChip® Microarray. The INFINITI EGFR Assay is automated by the INFINITI Analyzer. The INFINITI EGFR Assay is for research use only. Not for use in diagnostic procedures. Analytes Detected:  50 mutations […]

CHEK-2

INFINITI CHEK-2 The INFINITI CHEK-2 Assay is designed to identify CHEK2 genetic variants. The INFINITI CHEK-2 Assay utilizes the CHEK-2 Intellipac®, CHEK-2 Amp Mix and CHEK-2 BioFilmChip®Microarray. The INFINITI CHEK-2 Assay is automated by the INFINITI Analyzer. The INFINITI CHEK-2 Assay is for research use only. Not for use in diagnostic procedures. Analytes Detected:  CHEK2: 1100 […]

BRAF-XP

INFINITI BRAF XP The INFINITI BRAF XP assay is designed to identify genetic mutations of the BRAF gene. The INFINITI BRAF XP assay utilizes the BRAF XP Intellipac®, BRAF XP Amp Mix and BRAF XP BioFilmChip® Microarray. The INFINITI BRAF XP assay is automated by the INFINITI Analyzer. The INFINITI BRAF XP assay is for research use […]

5-FU

INFINITI 5-FU Assay The INFINITI 5-FU Assay is designed to detect mutations in the DYPD, MTHFR, and TYMS genes. The INFINITI 5-FU Assay utilizes the 5-FU Intellipac™, 5-FU Amp Mix and 5-FU BioFlimChip™ Microarray. The INFINITI 5-FU Assay is automated by the INFINITI Analyzer. The INFINITI 5-FU Assay is for research use only. Not for use in diagnostic procedures. […]

Factors Plus QUAD

INFINITI Factors Plus QUAD The INFINITI Factors Plus QUAD is designed to identify genetic variants for Factor II Plus, Factor V, and MTHFR genes.  The INFINITI Factors Plus QUAD Panel utilizes the Factors Plus QUAD Panel Intellipac®, Factors Plus QUAD Amp Mix and Factors Plus QUAD BioFilmChip® Microarray.  The INFINITI Factors Plus QUAD Panel is for research use only. Not for use in diagnostic procedures. Analytes Detected:  […]

Factor II Plus-V & MTHFR

INFINITI Factor II Plus-V & MTHFR The INFINITI Factor II Plus-V & MTHFR Panel is designed to identify genetic variants for Factor II, Factor V, and MTHFR genes.  The INFINITI Factor II Plus-V & MTHFR Panel utilizes the Factor II Plus-V & MTHFR Panel Intellipac®, Factor II Plus-V & MTHFR Panel Amp Mix and Factor […]

Factor II Plus-V

INFINITI Factor II Plus-V Panel The INFINITI Factor II Plus-V Panel is designed to identify genetic variants for Factor II and Factor V genes. The INFINITI Factor II Plus-V Panel utilizes the Factor II Plus-V Intellipac®, Factor II Plus-V Panel Amp Mix and Factor II Plus-V Panel BioFilmChip® Microarray. The INFINITI Factor II Plus-V Panel is […]

Factor II Plus

INFINITI Factor II Plus The INFINITI Factor II Plus assay is designed to identify genetic variants for Factor II.  The INFINITI Factor II Plus assay utilizes the Factor II Plus Intellipac®, Factor II Plus Amp Mix and Factor II Plus BioFilmChip® Microarray.  The INFINITI Factor II Plus assay is automated by the INFINITI Analyzer.  The INFINITI […]

Ashkenazi Jewish Panel

INFINITI Ashkenazi Jewish Panel Assay The INFINITI Ashkenazi Jewish Panel is designed to identify specific genetic mutations. The INFINITI Ashkenazi Jewish Panel utilizes the Ashkenazi Jewish Panel Intellipac, Ashkenazi Jewish Panel Amp Mix and Ashkenazi Jewish Panel BioFilmChip Microarray. The INFINITI Ashkenazi Jewish Panel is automated by the INFINITI Analyzer. The INFINITI Ashkenazi Jewish Panel […]

ApoE QUAD

INFINITI ApoE QUAD Assay The INFINITI ApoE QUAD Assay is designed to detect mutations in the ApoE gene. The INFINITI ApoE QUAD Assay utilizes the ApoE QUAD Intellipac™, ApoE QUAD Amp Mix and ApoE QUAD BioFlimChip™ Microarray. The INFINITI ApoE QUAD Assay is automated by the INFINITI Analyzer. The INFINITI ApoE QUAD Assay is for research use only. Not for […]

MDR1

INFINITI MDR 1 Assay    The INFINITI MDR1 Assay is designed to identify select genetic variants of MDR1. The INFINITI MDR1 Assay utilizes the MDR1 Intellipac, MDR1 Amp Mix and MDR1 BioFilmChip Microarray. The INFINITI MDR1 Assay is automated by the INFINITI Analyzer. The INFINITI MDR1 Assay is for research use only. Not for use in […]

CYP450 3A5

INFINITI CYP450 3A5 The INFINITI CYP450 3A5 Assay is designed to identify genetic variants of CYP450 3A5. The INFINITI CYP450 3A5 Assay utilizes the CYP450 3A5 Intellipac®, CYP450 3A5 Amp Mix and CYP450 3A5 BioFilmChip® Microarray. The INFINITI CYP450 3A5 Assay is automated by the INFINITI Analyzer. The INFINITI CYP450 3A5 Assay is for research use only. […]

CYP450 3A4

INFINITI CYP450 3A4 The INFINITI CYP450 3A4 Assay is designed to identify genetic variants of CYP450 3A4. The INFINITI CYP450 3A4 Assay utilizes the CYP450 3A4 Intellipac®, CYP450 3A4 Amp Mix and CYP450 3A4 BioFilmChip® Microarray. The INFINITI CYP450 3A4 Assay is automated by the INFINITI Analyzer. The INFINITI CYP450 3A4 Assay is for research use only. […]

Factor II-V & MTHFR

NFINITI Factor II-V & MTHFR Assay The INFINITI Factor II-V & MTHFR Assay is CE Marked. The INFINITI Factor II-V & MTHFR Assay is designed to identify genetic variants of Factor II, Factor V Leiden, and MTHFR genes. The INFINITI Factor II-V & MTHFR Assay utilizes the Factor II-Factor V Leiden-MTHFR Intellipac, Factor II-Factor V […]

MTHFR

INFINITI MTHFR Assay The INFINITI MTHFR Assay is CE Marked. The INFINITI MTHFR is designed to identify genetic variants of the MTHFR gene. The INFINITI MTHFR utilizes the MTHFR Intellipac, MTHFR Amp Mix and MTHFR BioFilmChip Microarray. The INFINITI MTHFR Assay is automated by the INFINITI Analyzer. Analytes Detected:  MTHFR: A1298C and C677T Features:  Simultaneous […]

Factor II

INFINITI System Assay for Factor II (IVD) The INFINITI System Assay for Factor II is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI System Assay for Factor II is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The INFINITI System Assay for Factor II utilizes the […]

CYP450 2C19+

INFINITI CYP450 2C19+ Assay The INFINITI CYP450 2C19+ is designed to identify genetic variants of CYP450 2C19. The INFINITI CYP450 2C19+ utilizes the CYP450 2C19+ Intellipac, CYP450 2C19+ Amp Mix and CYP 450 2C19+ BioFilmChip Microarray. The INFINITI CYP450 2C19+ Assay is automated by the INFINITI Analyzer. The INFINITI CYP450 2C19+ Assay is for research […]

CYP450 2C9-VKORC1

INFINITI CYP450 2C9-VKORC1 Assay INFINITI CYP450 2C9-VKORC1 is designed to identify CYP450 2C9 and VKORC1 genetic variants. INFINITI CYP450 2C9-VKORC1 utilizes the CYP450 2C9-VKORC1 Intellipac, CYP450 2C9-VKORC1 Amplification Mix and the CYP450 2C9-VKORC1 BioFilmChip Microarray. INFINITI CYP450 2C9-VKORC1 Assay is automated by the INFINITI Analyzer. The INFINITI CYP4502C9-VKORC1 Assay is for research use only. Not […]

CYP450 2D6-BC

INFINITI CYP450 2D6-BC Assay The INFINITI CYP450 2D6-BC is designed to identify genetic variants of CYP450 2D6. The INFINITI CYP450 2D6-BC utilizes the CYP450 2D6-BC Intellipac, CYP450 2D6-BC Amp Mix and CYP450 2D6-BC BioFilmChip Microarray. The INFINITI CYP450 2D6-BC Assay is automated by the INFINITI Analyzer. The INFINITI CYP450 2D6-BC Assay is for research use […]

CYP450 3A4-3A5

INFINITI CYP450 3A4-3A5 The INFINITI CYP450 3A4-3A5 Assay is designed to identify genetic variants of CYP450 3A4 and CYP450 3A5 The INFINITI CYP450 3A4-3A5 Assay utilizes the CYP450 3A4-3A5 Intellipac®, CYP450 3A4-3A5 Amp Mix and CYP450 3A4-3A5 BioFilmChip® Microarray. The INFINITI CYP450 3A4-3A5 Assay is automated by the INFINITI Analyzer. The INFINITI CYP450 3A4-3A5 Assay is for research use only. Not for use in diagnostic procedures. Analytes Detected:  CYP450 3A4: […]

FMF

INFINITI FMF Assay The INFINITI FMF is designed to identify specific genetic mutations. The INFINITI FMF utilizes the FMF Intellipac, FMF Amp Mix and FMF BioFilmChip Microarray. The INFINITI FMF Assay is automated by the INFINITI Analyzer. The INFINITI FMF Assay is for research use only. Not for use in diagnostic procedures. Analytes Detected:  A744S       […]

CFTR-31

INFINITI CFTR-31 Assay The INFINITI CFTR-31 Assay is designed to identify CFTR genetic variants. The INFINITI CFTR-31 Assay utilizes the CFTR-31 Intellipac, CFTR-31 Amp Mix and CFTR-31 BioFilmChip Microarray. The INFINITI CFTR-31 Assay is automated by the INFINITI Analyzer. The INFINITI CFTR-31 Assay is for research use only. Not for use in diagnostic procedures. Analytes […]

BRAF

INFINITI BRAF Assay The INFINITI BRAF is designed to identify genetic mutations of the BRAF gene. The INFINITI BRAF utilizes the BRAF Intellipac, BRAF Amp Mix and BRAF BioFilmChip Microarray. The INFINITI BRAF Assay is automated by the INFINITI Analyzer. The INFINITI BRAF Assay is for research use only. Not for use in diagnostic procedures. […]

KRAS

INFINITI KRAS Assay         The INFINITI KRAS Assay is designed to identify KRAS genetic mutations. The INFINITI KRAS Assay utilizes the KRAS Intellipac, KRAS Amp Mix and KRAS BioFilmChip Microarray. The INFINITI KRAS Assay is automated by the INFINITI Analyzer. The INFINITI KRAS Assay is for research use only. Not for use in diagnostic procedures. Analytes […]

KRAS-BRAF

INFINITI KRAS-BRAF Assay           The INFINITI KRAS-BRAF Assay is designed to identify KRAS and BRAF genetic mutations. The INFINITI KRAS-BRAF Assay utilizes the KRAS-BRAF Intellipac, KRAS-BRAF Amp Mix and KRAS-BRAF BioFilmChip® Microarray. The INFINITI KRAS-BRAF Assay is automated by the INFINITI Analyzer. The INFINITI KRAS-BRAF Assay is for research use only. Not for use in diagnostic […]

Flu A-sH1N1

INFINITI FLU A-sH1N1 The INFINITI FLU A-sH1N1 is designed to detect influenza A and differentiate between influenza A and influenza A subtype Swine H1N1 (2009). The INFINITI FLU A-sH1N1 utilizes the FLU A-sH1N1 Intellipac, FLU A-sH1N1 Amp Mix and the FLU A-sH1N1 BioFilmChip Microarray. The INFINITI FLU A-sH1N1 is automated by the INFINITI Analyzer. The […]

UGT1A1

INFINITI UGT1A1 Assay The INFINITI UGT1A1 is designed to identify UGT1A1 genetic variants. The INFINITI UGT1A1 utilizes the UGT1A1 Intellipac, UGT1A1 Amp Mix and UGT1A1 BioFilmChip Microarray. The INFINITI UGT1A1 Assay is automated by the INFINITI Analyzer. The INFINITI UGT1A1 Assay is for research use only. Not for use in diagnostic products. Analytes Detected:  UGT1A1: […]

Bacterial Vaginosis QUAD

INFINITI Bacterial Vaginosis QUAD The INFINITI Bacterial Vaginosis QUAD is designed to detect six pathogens. The INFINITI Bacterial Vaginosis QUAD utilizes the Bacterial Vaginosis QUAD Intellipac, Bacterial Vaginosis QUAD Amp Mix and the Bacterial Vaginosis QUAD BioFilmChip Microarray. The INFINITI Bacterial Vaginosis QUAD is automated by the INFINITI Analyzer. The INFINITI Bacterial Vaginosis QUAD is […]

HPV Genotyping

INFINITI HPV Genotyping The INFINITI HPV Genotyping panel is designed to detect 26 human papillomaviruses. The INFINITI HPV Genotyping panel utilizes the HPV Genotyping Intellipac, HPV Genotyping Amp Mix and HPV Genotyping BioFilmChip Microarray. The INFINITI HPV Genotyping panel can be automated by the INFINITI Analyzer. The INFINITI HPV Genotyping panel is for research use only. […]

HPV-HR QUAD

NFINITI HPV-HR Quad Assay The INFINITI HPV-HR QUAD Assay is designed to detect 14 human papilloma viruses. The INFINITI HPV-HR QUAD Assay utilizes the HPV-HR QUAD Intellipac, HPV-HR QUAD Amplification Mix and HPV-HR QUAD BioFilmChip Microarray. The INFINITI HPV-HR QUAD Assay is automated by the INFINITI Analyzer. The INFINITI HPV-HR QUAD Assay is for research […]

RVP Plus

INFINITI® RVP Plus Assay  The INFINITI RVP Plus Assay is designed to detect 25 common respiratory viruses. The INFINITI RVP Plus Assay utilizes the RVP Intellipac® (Primer Extension Mix), RVP Plus Amp Mix and RVP Plus BioFilmChip® Microarray. The INFINITI RVP Plus Assay is used with the INFINITI® PLUS Analyzer or the INFINITI® High Throughput System (HTS). The INFINITI […]

H pylori QUAD

INFINITI® H pylori QUAD Assay  The INFINITI H pylori QUAD Assay is designed to detect H pylori and two mutations in 23S Ribosomal RNA-2142G and 2143G.   The INFINITI H pylori QUAD Assay utilizes the H pylori QUAD Intellipac® (Primer Extension Mix), H pylori QUAD Amp Mix and H pylori QUAD BioFilmChip® Microarray.. The INFINITI H pylori QUAD Assay […]

Factor V Leiden

INFINITI System Assay for Factor V Leiden (IVD) The INFINITI System Assay for Factor V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI System Assay for Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The INFINITI System Assay for Factor V utilizes the Factor V Intellipac, Factor V […]

Factor II-V Leiden

NFINITI System Assay for Factor II-V Leiden (IVD) The INFINITI System Assay for Factor II-V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI System Assay for Factor II-V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia. The INFINITI System Assay for Factor II-V utilizes the Factor II […]

Warfarin Assay

INFINITI Warfarin Assay (IVD) The INFINITI Warfarin Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD). The INFINITI Warfarin Assay is indicated for use to identify individuals at risk for sensitivity to Warfarin. The INFINITI Warfarin Assay utilizes the Warfarin Assay Intellipac, Warfarin Assay Amp Mix and Warfarin Assay BioFlimChip Microarray. The INFINITI Warfarin […]

CYP2C19 Assay

INFINITI CYP2C19 Assay The INFINITI CYP2C19 Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).  The INFINITI CYP2C19 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for the therapeutics that are metabolized by the CYP450 2C19 gene product. The INFINITI CYP2C19 Assay is not indicated to be used to […]