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The GlutenID Celiac Genetic Health Risk Test uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from salva collected from individuals 18 years of age or older with ORAcollect Dx OCD-100 for the purpose of reporting and interpreting Genetic Health Risks (GHR). The GlutenID Celiac GHR Test is indicated for reporting of one variant associated with the HLA-DQ2.5 haplotype, one variant associated with the HLA-DQ8 haplotype, one variant associated with the HLA-DQ7 haplotype, and three variants associated with the HLA-DQ2.2 haplotype. The report describes if a person has variants linked to haplotypes associated with an increased risk for developing celiac disease, but it does not describe a person's overall risk of developing celiac disease. This report is most relevant for people of European descent.

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The ACTOnco IVD assay is an in vitro diagnostic test that uses targeted next generation sequencing of formalin-fixed. paraffin-embedded tumor tissue from patients with solid malignant neoplasms to detect genetic alterations in a broad multi gene panel. The test is intended to provide informations, small insertions and deletions, ERBB2 gene amplification, and tumor mutational burden for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. ACTOnco IVD is a single-site assay performed at ACT Genomics.

The ACTOnco IVD assay is an in-vitro diagnostic assay intended to provide information for use by qualified health care professionals in accordance with professional guidelines, and is not conclusive or prescriptive for labeled use of any specific therapeutic product. The assay is a custom targeted sequencing platform, utilizing amplicon-based sequencing, to detect point mutations (single nucleotide variants, or SNVs), small insertions and deletions (Indels), ERBB2 gene amplification, and tumor mutational burden (TMB) in tumor specimens. The assay uses custom DNA primers corresponding to all exons and selected introns of oncogenes, tumor suppressor genes, drug metabolism genes, and immune-related genes. Primers are synthesized by a secondary manufacturer (Thermo Fisher Scientific). An overlapping amplicon approach is utilized in which tiled primers are designed to generate multiple overlapping amplicons of the same region to avoid allele dropout. In total, the primers target approximately 1.8Mb of the human genome. Genomic DNA is extracted from FFPE tissue samples. Sequence libraries are prepared through a multiplex polymerase chain reaction (PCR) amplification step to enrich target sequences. Target sequences are tagged with index oligonucleotide to identify individual sample and adaptor oligonucleotide to anchor the amplicon to complimentary oligonucleotides embedded on the surface of the sequencing bead. Target sequences on the sequencing beads are amplified using emulsion PCR before sequencing. Multiple barcoded sequence libraries (from different patients) are pooled and then sequenced on a Thermo Fisher Ion GeneStudio™ S5 Prime System. Sequence reads are then aligned to the reference human genome. By comparing the identity of bases from the tumor DNA and the reference human genome, variant alterations are identified in the tumor. The assay system includes a sequencing instrument, reagents (DNA extraction, library preparation and sequencing), software (operation of the sequencing instrument and variant calling), and standard operating procedures (SOPs) for the use of the system. ACT Genomics takes the responsibilities in monitoring the instrument; reagents and consumable materials which will be used in the assay process. Multiple software components will be used in the assay. The NGS raw read analysis will be done using Thermo Fisher software. Variant calling for SNVs, insertions and deletions will be done using Thermo Fisher software. Mutation and variant annotation will be done using software from ACT Genomics, the Cunningham Lab and Golden Helix software. ERBB2 gene amplification will be done using software from Boeva Lab. Tumor Purity and Zygosity will be done using software from Halgamuge Lab (Kaushalya Amarasinghe). Calculations for tumor mutational burden will be done using ACT Genomics software.

The MagXtract Collection Tube is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA. These devices can be used for collection transport and storage of specimens at refrigerated (2-8℃) or ambient temperatures (20-25℃). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.

The MagXtract collection tube is intended for the collection, transportation, direct lysis, and stabilization of RNA from unprocessed nasopharyngeal swab samples suspected of containing SARS-COV-2. The MagXtract collection tube stores and transports specimens in a closed tube. Proper specimen collection and transport are essential in molecular testing and obtaining accurate test results. MagXtract collection tube allows for the stabilization and transportation of nasopharyngeal swab samples at ambient temperature from the collection site to the processing laboratory. The MagXtract collection tube consists of a sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer (MagBio CTL Medium). MagBio CTL Medium is intended to disrupt/lyse cells and stabilize SARS-COV-2. The preserved and stabilized RNA maintains its integrity for downstream molecular based detection/analysis. MagXtract collection tube may be used in conjunction with a swab or as a tube alone.

The AncestryDNA Factor V Leiden Genetic Health Risk Test for Hereditary Thrombophilia uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals 18 years and older with the AncestryDNA Saliva Collection Kit for the purpose of reporting and interpreting Genetic Health Risks (GHR). The AncestryDNA Factor V Leiden Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene. This report describes if a person has variants associated with a higher risk of developing harmful blood clots, but it does not describe a person's overall risk of developing harmful blood clots. This test is most relevant for people of European descent.

A user's saliva is self-collected using the AncestryDNA Saliva Collection Kit, which consists of a sealable collection tube containing a stabilizing buffer solution. Once the sample is collected, it is shipped to one of two Clinical Laboratory Improvement Amendments (CLIA) certified laboratories for processing. DNA is isolated from the saliva, quantified, and tested in a multiplex assay using a customized genotyping chip and instrumentation manufactured by Illumina. The multiplex assay simultaneously tests for more than 500,000 variants, including those for the indication proposed herein. The raw data is generated using Illumina GenomeStudio software, and then sent to Ancestry Genomics (the Manufacturer). The data are analyzed using the Manufacturer's proprietary GHR software, and a genotype is determined for each tested variant. The results for the Factor V Leiden variant are used to generate personalized reports for users that provide information about the disease associated with the detected variant. Personalized reports are generated for each user that provide results of the testing performed. These reports tell the user which variant(s) has/have been detected in their sample and provide information on the risk of disease associated with the variant(s). If no variant was detected, that information is also provided. The personalized reports are designed to present scientific concepts to users in an easy-to-understand format. The reports provide scientifically valid information about the risks associated with the presence of a particular variant. The reports are designed to help users understand the meaning of their results and any appropriate actions that may be taken based on their results.

The AncestryDNA Saliva Collection Kit is intended for use in the noninvasive collection of saliva samples for in vitro diagnostic testing of human DNA. Saliva may be collected by spitting directly into the AncestryDNA Saliva Collection Kit by a lay user. Saliva samples collected using the AncestryDNA Saliva Collection Kit are stabilized and isolated for use with over-the-counter AncestryDNA Genetic Health Risk Tests. Saliva samples collected using the AncestryDNA Saliva Collection Kit can be transported and/or stored long term at ambient conditions.

The AncestryDNA Saliva Collection Kit consists of: saliva collection tube, funnel, cap, blister pack, collection bag with absorbent pad, return mailer, and Instructions for Use. The collection device consists of the saliva collection tube, funnel, and cap. The cap contains DNA stabilization solution. Saliva is delivered directly by spitting into the collection tube via the funnel. Once the user has provided the saliva sample, s/he removes the funnel from the saliva collection tube and affixes the cap. Affixing the cap by screwing on releases the stabilization solution. The user is then instructed to shake the tube for at least five seconds to mix the saliva sample with the stabilization solution. After collecting the saliva sample, the user places the closed saliva collection tube in the collection bag. The collection bag with the enclosed saliva collection tube is shipped to a designated Ancestry Genomics location for testing via the pre-addressed postage paid return mailer.

The INFINITI CYP2C19 Assay is an in vitro diagnostic test for the identification of a patient's CYP450 2C19 genotype in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI CYP2C19 Assay is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI CYP2C19 Assay is indicated for use as an aid to clinicians in determining therapeutic strategy for therapeutics that are metabolized by the CYP450 2C19 gene product, specifically *2, *3, *17. The INFINITI CYP2C19 Assay is not indicated to be used to predict drug response or non-response.

The INFINITI CYP2C19 Assay is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management, and software technology for the detection and genotyping of the 2C19 *2, *3, and *17 mutations in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI CYP2C19 Assay is comprised of the BioFilmChipTM Microarray, the Intellipac Reagent Module and the PCR Amplification Mix. The INFINITI CYP2C19 Assay should be run using the AutoGenomics INFINITI Analyzer. The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific. The Intellipac Reagent Module contains up four reservoirs that house the test reagents and has an integrated memory chip. Information on the reagent such as lot number, expiration date and remaining tests, are archived in the memory. The PCR Amplification Mix consists of the reagents needed for the PCR amplification step of the assay. The INFINITI CYP2C19 Assay is based on the following processes: (a) DNA extraction (b) PCR amplification of purified DNA from human genomic DNA (c) Labeling of the amplified product (allele specific primer extension) (d) Hybridization of the labeled amplified product to a microarray by signature Tag/Capture probe hybridization under isothermal conditions. (e) Scanning of the microarray (f) Signal detection and analysis Steps (c) through (f) are automated by the INFINITI Analyzer. The INFINITI Analyzer automates the 2C19 assay and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, and results The assays are processed automatically and read by the built-in confocal analysis. microscope. Results are analyzed and presented as genotype calls.

The Respisens system is intended to monitor patient motion in real time during radiotherapy. In particular, the system is intended to monitor breath hold and to detect undesirable patient motion. Monitoring respiratory motion during breath hold is essential in ensuring patient safety. The system warns the operator when breath hold is not maintained properly. Verifying that the patient stays completely still during treatment is also fundamental. The system can detect patient movement and warn the operator when necessary.

The Respisens system monitors patient motion in real time during radiotherapy. The system is based on a transmitter/receiver that measures distance. When placed on the patient's thorax or abdomen, the system tracks breathing and thus helps monitoring and securing breath hold manoeuvres. If placed on a motionless part of the patient, it helps verify immobility. The underlying technology is a magnetic distance sensor that is capable of measuring movements with high sensitivity. The Respisens system is composed of a Respisens measurement module and an Interface Box, their accessories, and a user interface software. The Respisens measurement module drives the sensor. The Interface Box is the control core of the system. It sits in the control room and handles the communication with the PC, the calculation of the time lag in signal display introduced by the PC, the detection of the status of the radiation beam, and the alarms.

The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic test for the detection and genotyping of the *2 and *3 CYP4502C9 genetic variants and the VKORC1 3673 (-1639) intronic variant in genomic deoxyribonucleic acid (DNA) obtained from EDTA-anticoagulated whole blood samples. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is indicated for use to identify individuals at risk for sensitivity to warfarin.

The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management, and software technology for the detection and genotyping of the 2C9*2, 2C9*3, and VKORC1 3673 (-1639) mutations from EDTA-anticoagulated whole blood samples. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is comprised of the BioFilmChip™ Microarray, the Intellipac Reagent Module and the PCR Amplification Mix. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin should be run using the AutoGenomics INFINITI Analyzer. The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific. The Intellipac Reagent Module contains up to eight reservoirs that house the test reagents and has an integrated memory chip. Information on the reagent such as lot number, expiration date and volume usage, are archived in the memory. The PCR Amplification Mix consists of the reagents needed for the PCR amplification step of the assay. The INFINITI 2C9 & VKORC1 Multiplex Assay for Warfarin is based on the following processes: (a) DNA extraction (b) PCR amplification of purified DNA from human genomic DNA (c) Labeling of the amplified product (allele specific primer extension) (d) Hybridization of the labeled amplified product to a microarray by signature Tag/Capture probe hybridization under isothermal conditions. (e) Scanning of the microarray (f) Signal detection and analysis [determination of the 2C9*2, 2C9*3 and VKORC1 3673 (-1639) genotypes] Steps (c) through (f) are automated by the INFINITI Analyzer. The INFINITI Analyzer automates the 2C9 and VKORC1 assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented as genotype calls.

The INFINITI™ System Assay for Factor II & Factor V is an in vitro diagnostic device that consists of reagents and instrumentation which includes polymerase chain reaction (PCR) primers, hybridization matrices, a thermal cycler, an imager, and software for detection and genotyping of Factor II (Prothrombin) G20210A and Factor V Leiden G1691A point mutations in DNA obtained from human blood samples. The INFINITI™ System Assay for Factor II & Factor V is a qualitative assay for use in clinical laboratories upon prescription by the attending physician. The INFINITI" System Assay for detection and genotyping of Factor II & 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 II & Factor V is an in vitro diagnostic device which utilizes proprietary film-based microarray technology combined with process automation, reagent management and software technology for the detection and genotyping of the Factor II (Prothrombin) G20210A mutation and the Factor V Leiden G1691A mutation from deoxyribonucleic acid (DNA) isolated from human whole peripheral blood samples. The INFINITI System Assay for Factor II & Factor V is comprised of the BioFilmChip" Microarray, the Intellipac™ Reagent Module, and the INFINITI Analyzer with the Qmatic" Operating Software. The BioFilmChip Microarray consists of a polyester film coated with proprietary multi-layer components designed for DNA analysis. The layers have been designed to provide a versatile surface to enhance test performance. There can be up to 240 spots per microarray with each spot representing a different allele. The microarrays are designed to be assay specific. The Intellipac Reagent Module which acts as a communication link contains up to eight reservoirs that house the test reagents and has an integrated memory chip. The assay protocol resides in this memory chip and upon request is loaded to the INFINITI Analyzer. Information such as expiration date of reagents, volume usage, time of use and operation parameters are archived in the memory chip and appear on the worklist (run report). The INFINITI Analyzer is an instrument used for clinical multiplex systems intended to measure and sort multiple signals from a clinical sample. The INFINITI Analyzer is designed to measure fluorescence signals of labeled DNA target hybridized to BioFilmChip microarrays. The INFINITI Analyzer automates the Factor II and Factor V assays and integrates all the discrete processes of sample (PCR amplicon) handling, reagent management, hybridization, detection, and results analysis. The assays are processed automatically and read by the built-in confocal microscope. Results are analyzed and presented in numerical and graphical format. The INFINITI Analyzer has two main components: pipetting and optics modules. A variety of electronic components inside the instrument are used for its operation. These include multiple stepper motors, heating and cooling devices, a barcode reader, a photomultiplier tube, and a camera all connected to USB ports. Pipetting Module - The pipetting module performs all the operations related to dispensing and aspiration of reagent and processing the amplified sample to be dispensed on the microarray. When the sample has been processed and hybridized to the microarray, it is transferred to the optics module for scanning and reading. Optics Module - The optics module is a lightproof assembly comprised of a 3-axis stage: camera, lasers, and a photo multiplier tube (PMT). It is the enclosed casement into which the microarray is transported automatically prior to being processed on the stringency station. The optics' stage follows X-Y-Z motions that can be stepped at a very precise rate (2.0 micron per step). Using excitation wavelengths of a 760nm laser diode, the camera takes a 1.2x1.2mm picture for each registration spot of a fluorescent die. Analyses of these pictures allow the location of three registration spots to be determined. With respect to the position of the three registration spots, coordinates of all the bio-spots can be located. While scanning, the stage moves along the Z-axis to focus the chip and the X and Y-axes to locate the individual spots on the microarray. The INFINITI Analyzer hardware is controlled by the Qmatic™ operating software, which is installed with-in the on-board computer and utilizes a LCD screen display. The INFINITI Analyzer modules are controlled by multitasking real time software. The Omatic "M operating software has a schedule manager that is capable of controlling all operations of the INFINITI Analyzer such as assay protocol, fluid handling, robotics, optical detection and result analysis. Results are available for review via the LCD screen. Management reports include results in numerical and graphical format. The operator can also print the displayed results in tabular form (printer not included with INFINITI Analyzer).