Test Information
Understanding Your Genetic Tests
Detailed information about our testing technology, report types, important limitations, and FDA disclosures.
About Our Tests
The AJO Personal Genome Service (PGS) test uses qualitative genotyping to detect select clinically relevant variants in the genomic DNA of adults from saliva for the purpose of reporting and interpreting genetic health risks and reporting carrier status. Our DNA collection kit is FDA-cleared for use with our Genetic Health Risk, Cancer Predispositions, Pharmacogenetics, and Carrier Status reports and manufactured in accordance with FDA's current Good Manufacturing Practice regulations.
All saliva samples are processed in CLIA-certified and CAP-accredited labs using a custom version of the Illumina Global Screening Array. This technology allows the identification of specific genetic variants that can be informative about your health and ancestry.
Genotyping vs. Sequencing
Genotyping examines DNA variants at certain pre-identified positions in the genome. The specific variants we look at provide coverage of common known variations across the entire genome. Many variants can be accurately and efficiently examined at once using genotyping chips, also known as microarrays. This is the technology used to power the 190+ genotyping reports that you will receive.
Exome Sequencing is an advanced type of genetic testing which involves determining the exact sequence of a certain length of DNA. It can be used to examine known variants, as well as identify variants that are unknown, providing you with a more complete picture of your genetic predispositions for certain health conditions. Exome sequencing looks at approximately 40 times more DNA bases than microarray genotyping chips, focusing on the protein-coding regions that make up only about 1-2% of the entire genome but contain the majority of genetic variants associated with disease risk.
Report Categories
Health Predispositions
10+FDA requirements
Pharmacogenetics
5+FDA requirements
Carrier Status
45+FDA requirements — includes Cystic Fibrosis, Sickle Cell Anemia, Hereditary Hearing Loss
Ancestry Service
50+Wellness
5+Traits
30+Health Predisposition & Carrier Status Reports
The AJO PGS test includes health predisposition and carrier status reports. Health predisposition reports include both reports that meet FDA requirements for genetic health risks and reports which are based on AJO research and have not been reviewed by the FDA.
It is not intended to diagnose any disease. Your ethnicity may affect the relevance of each report and how your genetic health risk results are interpreted. Each genetic health risk report describes if a person has variants associated with a higher risk of developing a disease, but does not describe a person's overall risk of developing the disease.
The test is not intended to tell you anything about your current state of health, or to be used to make medical decisions, including whether or not you should take a medication, how much of a medication you should take, or determine any treatment.
Our carrier status reports can be used to determine carrier status, but cannot determine if you have two copies of any genetic variant. These carrier reports are not intended to tell you anything about your risk for developing a disease in the future, the health of your fetus, or your newborn child's risk of developing a particular disease later in life.
BRCA1/BRCA2 (Selected Variants)
The AJO PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) is indicated for reporting of 44 variants in the BRCA1 and BRCA2 genes. The report describes if a person's genetic result is associated with an increased risk of developing breast cancer and ovarian cancer and may be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers.
Important limitations:
●The variants included in this report do not represent the majority of the BRCA1/BRCA2 variants in people of most ethnicities
●This report does not include variants in other genes linked to hereditary cancers
●The absence of variants included in this report does not rule out the presence of other genetic variants that may impact cancer risk
●This report is for over-the-counter use by adults over the age of 18
●The PGS test is not a substitute for visits to a healthcare professional for recommended screenings or appropriate follow-up
●Results should be confirmed in a clinical setting before taking any medical action
Pharmacogenetics Reports
The AJO test uses qualitative genotyping to detect 3 variants in the CYP2C19 gene, 2 variants in the DPYD gene and 1 variant in the SLCO1B1 gene in the genomic DNA of adults from saliva for the purpose of reporting and interpreting information about the processing of certain therapeutics to inform discussions with a healthcare professional.
CYP2C19: Provides information about variants associated with metabolism of some therapeutics and provides interpretive drug information regarding the potential effect of citalopram and clopidogrel therapy.
SLCO1B1: Provides information about variants associated with the processing of some therapeutics and provides interpretive drug information regarding the potential effect of simvastatin therapy.
DPYD: Does not describe the association between detected variants and any specific therapeutic. DPYD and certain CYP2C19 results should be confirmed by an independent genetic test prescribed by your own healthcare provider before taking any medical action.
Warning: Test information should not be used to start, stop, or change any course of treatment and does not test for all possible variants that may affect metabolism or protein function. The PGS test is not a substitute for visits to a healthcare professional. Making changes to your current regimen can lead to harmful side effects or reduced intended benefits of your medication, therefore consult with your healthcare professional before taking any medical action.
Exome Sequencing (AJO+ Total Health)
The 100+ genes included in the AJO+ Total Health Exome Sequencing reports are carefully selected to provide high-impact genetic risk information for 55+ conditions. These include all of the genes considered "medically actionable" by the American College of Medical Genetics and Genomics (ACMG) along with other genes that can provide both clinical and personal benefit.
Overall, the genes selected can inform you about conditions that are often underdiagnosed. But, if detected early, there are many effective preventive measures and clinical interventions.
Timeline: You will receive your exome sequencing reports 7-12 weeks after you receive your genotyping reports.
Clinical Services
Clinical services are provided by healthcare providers which includes board-certified physicians and nurse practitioners. All clinicians have unique knowledge and training in genetics-informed care.
After receiving your PGS results, you will have unlimited messaging with clinicians and the opportunity to schedule your virtual consultation once exome results are returned.
For each of the two blood tests included in AJO+ Total Health, you will receive your analysis of 55+ biomarkers 3-5 business days after completing your blood draw.
Research Participation
80% of our customers choose to participate in AJO research by answering online survey questions. On average, a customer who opts in to research contributes to more than 200 studies on topics that include behavior, cancer, dermatology, hematology, immunology, musculoskeletal, neurology, psychiatry, reproduction and rare disease.
By participating in online surveys and allowing researchers to combine their aggregated, de-identified genetic data with other data points, customers can help drive scientific and medical discoveries forward — particularly for underrepresented communities.
We collaborate with leading researchers in academia and pharma from around the world to improve understanding of the underlying genetics of certain diseases, which could lead to better diagnostics and treatments.
Questions About Testing?
Contact our medical team or speak with a genetic counselor through the National Society of Genetic Counselors.
Contact medical@ajo.co