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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 AlphaID™ At Home Genetic Health Risk Service uses qualitative genotyping to detect clinically relevant genetic variants associated with alpha-1 antitrypsin deficiency (AATD) in genomic DNA isolated from human saliva collected from individuals ≥ 18 years with ORAcollect Dx OCD-100.014 for the purpose of reporting and interpreting Genetic Health Risks (GHR). This Service is indicated for reporting 14 genetic variants in the SERPINA1 gene: PI*S; PI*M procida; PI*M malton; PI*S iiyama; PI*Q0 granite falls; PI*Q0 west; PI*Q0 bellingham; PI*F; PI*Q0 mattawa; PI*Q0 clayton, and PI*M heerlen. The report describes if a person is at an increased risk of developing either liver disease linked to AATD. The report does not describe a person's overall risk of developing lung and/or liver disease. AATD is more common in persons of European descent.

The AlphaID™ At Home Genetic Health Risk Service (AlphaID At Home) uses qualitative genotyping to detect clinically relevant genetic variants associated with alphal-antitrypsin deficiency (AATD) and provides a report describing if a person is at risk of developing either lung and/or liver disease linked to AATD. This Service is direct-to-consumer and intended for an Over-the Counter (OTC) use. The AlphaID™ At Home Genetic Health Risk Service is composed by AlphaID™ At Home Saliva Collection kit for human saliva sample collection (ORAcollect®·Dx OCD-100.014), A1AT Genotyping Test for the genetic analysis and detection of genetic variants associated with alpha-1 antitrypsin deficiency (AATD), and AlphaID™ At Home Genetic Health Risk Service website and result portal software to provide the contents and the procedure to order and use the over the counter (OTC) Service. A consumer's saliva is self-collected using custom version ORAcollect Dx (model OCD-100.014) device manufactured by DNA Genotek, Inc (See K212745) which consists of collection tube containing a stabilizing buffer solution. Once the sample is collected, it is shipped to Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for processing. Human DNA from the saliva sample is isolated and processed with the A1AT Genotyping Test device (K211115) that provides results on 14 genetic variants in the SERPINA / gene: PI*S; PI*Z; PI*M procida; PI*M malton; PI*S iiyama; PI*O0 granite falls: PI*O0 west: PI*O0 bellingham: PI*F; PI*P lowell; PI*O0 mattawa; PI*Q0 clayton, and PI*M heerlen. Briefly, genomic DNA extracted from human saliva is amplified and biotinylated by multiplex PCR and PCR products are denatured and hybridized to oligonucleotide probes coupled to color-coded beads. Hybridized DNA is labeled with a fluorescent conjugate and the resulting signal is detected with a Luminex® 200™ system. Raw fluorescence data is processed with the A1AT Genotyping Test ANALYSIS SOFTWARE to provide allelic variant genotypes, which are subsequently converted into associated alleles, based on current scientific evidence. Additionally, the software application also provides the type of Genetic Health Risk Report associated with the identified alleles, which is subsequently used as the basis for the generation of personalized reports by the AlphaID™ At Home Genetic Health Risk Service website and result portal. Depending on the specific variant combination detected, the AlphaID™ At Home Genetic Health Risk Service provides the individuals' genetic health risk for developing lung and liver disease linked to AATD. Personalized reports, in an easy-to-understand format are generated for each consumer that provide results of the testing performed.

The Helix Genetic Health Risk App (HRA) uses qualitative genotyping to detect clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with Oragene®Dx OGD-610 for the purpose of reporting and interpreting Genetic Health Risks (GHR): The Helix Genetic Health Risk App (HRA) for late-onset Alzheimer's disease is indicated for reporting of the e2/e2, e2/e3, e2/e4 and e4/e4 genotypes in the APOE gene. The report describes if a person's genetic result is associated with an increased or decreased risk of developing late-onset Alzheimer's disease. The e2 and e4 variants included in this report are found and have been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent. The Helix Genetic Health Risk App (HRA) is to be used with the Helix Laboratory Platform.

The Helix Genetic Health Risk App is an over-the-counter (direct-to-consumer), DNA testing service that provides information and tools for consumers to learn about and explore their DNA. The Helix Genetic Health Risk App is a currently marketed, non-invasive genetic information service that combines qualitative genotyping data indicate for late-onset Alzheimer's disease for reporting of the e2/e2, e2/e3, e2/e4, e3/e3, e3/e4 and e4/e4 genotypes in the APOE gene with descriptive information derived from peer reviewed, published genetic research studies. It is a home use, over-the-counter (direct-to-consumer) DNA testing service intended to provide information and tools for consumers to learn about and explore their DNA. Customer saliva is selfcollected using the FDA cleared Oragene®·Dx OGD-610 saliva collection kit manufactured by DNA Genotek, Inc. (k192920), which consists of a sealable collection tube containing a stabilizing buffer solution. Once the sample is collected, it is shipped to the CLIA-certified and College of American Pathologists (CAP) -accredited Helix laboratory for testing. DNA is isolated from the saliva and tested using Helix's proprietary whole exome sequencing assay authorized under DEN190035 in the Helix laboratory. The genomic DNA is processed and sequenced using next generation sequencing (NGS) reagents and instrumentation manufactured by Illumina. The sequencing data is analyzed using Helix's proprietary software, where the genetic variants of interest are determined. All samples must pass Helix's stringent quality control metrics prior to analysis. Samples that do not pass quality thresholds will undergo re-sequencing and/or sample re-collection. The genetic variant results are used to generate personalized reports that provide information about the detected genotype for the customer. These reports tell the user which genotype has/have been detected in their sample and provide information on the risk of disease associated with the genotype. If no genotype was determined, that information is also provided. The personalized reports are designed to present scientific concepts to users in an easy-tounderstand format. The reports provide scientifically valid information about the risks associated with the presence of a particular genetic 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 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 23andMe Personal Genome Service (PGS) Test uses qualitative genotyping to detect the following clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with the Oragene Dx model OGD-500.001 for the purpose of reporting and interpreting Genetic Health Risks (GHR): The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene, and the Prothrombin G20210A variant in the F2 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. The 23andMe PGS Genetic Health Risk Report for Alpha-1 Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene. This report describes if a person has variants associated with AAT deficiency and a higher risk for lung or liver disease, but it does not describe a person's overall risk of developing lung or liver disease. This test is most relevant for people of European descent. The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer's Disease is indicated for reporting of the £4 variant in the APOE gene. The report describes if a person's genetic result is associated with an increased risk of developing Late-onset Alzheimer's Disease, but it does not describe a person's overall risk of developing Alzheimer's Disease. The £4 variant included in this report is found and has been studied in many ethnicities. Detailed risk estimates have been studied the most in people of European descent. The 23andMe PGS Genetic Health Risk Report for Parkinson's Disease is indicated for reporting of the G2019S variant in the LRRK2 gene and the N370S variant in the GBA gene. The report describes if a person's genetic result is associated with an increased risk of developing Parkinson's disease, but it does not describe a person's overall risk of developing Parkinson's disease. The test is most relevant for people of European, Ashkenazi Jewish, and North African Berber descent. The 23andMe PGS Genetic Health Risk Report for Gaucher Disease Type 1 is indicated for reporting of the N370S, 84GG, and V394L variants in the GBA gene. This report describes if a person has variants associated with an increased risk for developing symptoms of Gaucher Disease Type 1, but it does not describe a person's overall risk of developing Gaucher Disease Type 1. This test is most relevant for people of Ashkenazi Jewish descent. The 23andMe PGS Genetic Health Risk Report for Factor XI Deficiency is indicated for reporting of the variants F283L. E117X. IVS14+1G>A in the F11 gene. This report describes if a person has a variant associated with Factor XI deficiency and the potential for a higher risk of excessive bleeding following trauma or surgery, but it does not describe a person's overall risk for excessive bleeding. This test is most relevant for people of Ashkenazi Jewish descent. The 23andMe PGS Genetic Health Risk Report for Celiac Disease is indicated for reporting of a variant associated with the HLA-DQ2.5 haplotype. The report describes if a person has a haplotype associated with an increased risk of developing celiac disease, but it does not describe a person's overall risk for developing celiac disease. This report is most relevant for people of European descent. The 23andMe PGS Genetic Health Risk Report for Glucose-6-Phosphate-Dehydrogenase Deficiency is indicated for reporting of the Val68Met variant in the G6PD gene. This report describes if a person has a variant associated with G6PD deficiency and a higher risk for episodes of anemia, but it does not describe a person's overall risk of developing anemia. This test is most relevant for people of African descent. The 23andMe PGS Genetic Health Risk Report for Hereditary Hemochromatosis is indicated for reporting of the C282Y and H63D variants in the HFE gene. This report describes if a person has variants associated with hereditary hemochromatosis and a higher risk for iron overload, but it does not describe a person's overall risk of developing iron overload. This report is most relevant for people of European descent. The 23andMe PGS Genetic Health Risk Report for Early-Onset Primary Dystonia (DYT1/TOR1A-Related) is indicated for reporting of the deltaE302/303 variant in the DYT1 gene. This report describes if a person has variants associated with a higher risk for early-onset primary dystonia, but it does not describe a person's overall risk of developing dystonia. This report is most relevant for people of Ashkenazi Jewish descent.

The 23andMe PGS is a currently-marketed, non-invasive genetic information service that combines qualitative genotyping data covering genetic ancestry, traits, and certain heritable health conditions from a single multiplex assay with descriptive information derived from peer reviewed, published genetic research studies. It is a direct-toconsumer, over-the-counter, non-diagnostic, DNA genetic testing service intended to provide information and tools for individual users. A user's saliva is self-collected using the Oragene-Dx device manufactured by DNA Genotek, Inc. (previously cleared under K141410), 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 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 indications proposed herein. The raw data is generated using Illumina GenomeStudio software, and then sent to 23andMe (the Manufacturer). The data are analyzed using the Manufacturer's proprietary Coregen software, and a genotype is determined for each tested variant. The results for certain of these variants are used to generate personalized reports for users that provide information about the diseases 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.