General Questions
Who should get OneTest™ Standard or OneTest™ Premium?
OneTest™ Standard and OneTest™ Premium were developed to assess an individual’s risk of being identified as having cancer within 12 months of the test. OneTest™ Premium includes OneTest™ Standard and additional markers. While cancer can occur in individuals of any age, it occurs more frequently in older people. As such, the test is generally of greater value in individuals 50 years of age and older, however for those expected to be at higher risk of cancer at an earlier age, due to environmental or occupational exposures to cancer causing agents or family history of cancer, the tests can be applied at a younger age. The test development population included individuals as young as 18 years old and therefore OneTest™ is available to persons in the US who are at least 18 years of age. Customers must obtain a test authorization from a licensed medical provider and obtain a blood specimen. OneTest™ is not recommended for persons with symptoms of cancer, those who are currently in treatment for cancer or those who are concerned about disease recurrence. These individuals will generally benefit from more intensive screening tests rather than risk prediction.
How do OneTest™ Standard and OneTest™ Premium work?
OneTest™ Standard and OneTest™ Premium are blood tests that analyzes a number of blood-based protein biomarkers to assess a composite cancer risk. OneTest™ Standard uses a panel of 5 (male) or 6 (female) cancer biomarkers and categorizes aggregated risk for more than 20 different cancer types. OneTest™ Premium uses an expanded biomarker panel of 11 cancer and inflammatory biomarkers to assess cancer-specific risk for eight of the most common cancer types (6 in males and 7 in females). OneTest™ Premium report also includes the OneTest™ Standard report.
OneTest™ Standard and OneTest™ Premium use cutting-edge artificial intelligence and real-world data to dramatically enhance test sensitivity and early detection. Our tests go further than a simple genetic test, and offer clinical biomarker data that can be used by your health professional to determine your cancer risk and inform next steps for early detection. OneTest™ Standard and OneTest™ Premium are built around panels of clinically established protein antigens, that the measure of which are proven to be highly correlated with many common cancers. By utilizing OneTest™ Standard or OneTest™ Premium, you can experience enhanced peace of mind and proactively manage your cancer risks.
What cancers does OneTest™ Standard screen for?
OneTest™ Standard includes the risk evaluation for any of the following cancers, but does not specify cancer type.
Common Cancers: Breast, Lung, Kidney, Prostate, Pancreas, Ovarian, Cervical, Liver, Colon, Stomach, Esophageal
Less Common Cancers: Brain, Bladder, Head & Neck, Thyroid, Leukemia, Lymphoma, Uterus, Gallbladder, Intrahepatic Bile Ducts, Parotid (Salivary), Liposarcoma, Nasal Neuroendocrine, Retroperitoneum, Skin, Testicle
How accurate is OneTest™ Standard?
OneTest™ Standard is designed to predict the risk of being diagnosed with cancer within 12 months. We assessed its performance using data from 27,816 individuals, where 220 were diagnosed with cancer in the following year, resulting in a 0.8% incidence rate.
Mildly elevated risk category: Considering both mildly and moderately elevated risk categories, the test achieves a 73.2% sensitivity but has a higher 19.1% false positive rate. In our cohort, 5,275 out of 27,596 individuals without cancer were mistakenly identified, while 161 of the 220 individuals who developed cancer were correctly identified. The overall accuracy in both categories is 80.8%.
Moderately elevated risk category: If we focus on moderately elevated risk, the test has a 1.6% false positive rate and a 23.2% sensitivity. This means that, among 27,596 individuals who didn’t develop cancer, 449 were mistakenly identified, while 51 of the 220 individuals who did develop cancer were correctly identified. Overall accuracy in this category is 97.8%.
For more detailed information, visit our Science page.
How accurate is OneTest™ Premium?
OneTest™ Premium is carefully developed to predict the risk of being identified with eight specific cancer types within the next 12 months, utilizing case-control studies with over 2000 individual subjects. Here are the performances for individual cancers:
Cancer Type | Sensitivity | Specificity |
Breast | 33.6% | 95.5% |
Colon | 80.1% | 95.1% |
Liver | 92.2% | 98.0% |
Lung | 60.5% | 95.0% |
Prostate | 93.4% | 95.0% |
Stomach | 53.4% | 95.0% |
Pancreas | 93.6% | 95.1% |
Ovary | 90.7% | 95.4% |
Should OneTest™ replace other cancer screening tests?
No. OneTest™ does not replace other recommended screening tests such as colonoscopy, mammogram, pap smears, low dose computed tomography, etc. These tests should continue to be utilized per standard medical guidance. While a “Low” risk categorization by OneTest™ is a promising indicator that you may be cancer free, OneTest™ can miss as many as 26.8% of cancers and therefore is intended as an adjunct to these and other cancer screening modalities. These other screening tests look for cancer in other ways which are complimentary to the approach used by OneTest™.
Are OneTest™ Standard and OneTest™ Premium one-time tests?
OneTest™ Standard and OneTest™ Premium can only predict cancer risk for a 12 month period subsequent to testing and therefore are most effective when used on a yearly basis. While our current tests can only give you a snapshot of your current risk, your first test will also provide a baseline of your cancer biomarker values. Annual testing may help identify significant changes in cancer biomarkers which may be due to a developing tumor. Baseline biomarker values, together with recent changes in those values and factors such as age, family cancer history, and environment/occupational exposures may be considered when determining a personalized plan for testing frequency.
What is the difference between OneTest™ and other ct/cfDNA tests?
OneTest™ Standard and OneTest™ Premium are protein biomarker-based multi-cancer early detection (MCED) tests that predict an individual’s risk for being identified as having cancer in the subsequent 12-month period. Some other MCED tests utilize ctDNA and/or use methylated cfDNA signature patterns to detect cancer and to identify cancer type.
OneTest™ Standard and OneTest™ Premium:
- Relies on well-established protein biomarkers tested with FDA-approved kits.
- Provides clear and interpretable individual biomarker values that can be monitored over time for enhanced cancer prediction.
- Allows patients and healthcare providers to determine follow-up based on risk levels and clinical information.
- OneTest™ Premium option provides enhanced sensitivity and specificity for eight detected cancer types.
- Does not directly predict the organ of origin for cancer, but provides biomarker values that can be used to guide further testing to help identify organ of origin
ct/cfDNA Tests:
- Utilizes next-generation sequencing and machine-learning algorithms to analyze methylation patterns in cell-free DNA (cfDNA).
- Uses proprietary lab-developed test for analyzing methylated cfDNA. These methods are not FDA-approved.
- The data used for development of these tests is primarily derived from case-control studies and do not necessarily reflect the intended use population (i.e. asymptomatic, not yet diagnosed individuals).
- cfDNA values/sequences are not interpretable by healthcare providers and as such are not reported.
- Generally report a simple “cancer detected” or “cancer not detected” result rather than a risk prediction.
Choose between OneTest™ Standard and OneTest™ Premium.
OneTest™ Standard assesses your risk of being diagnosed with over 20 cancers within the next 12 months by measuring 5 or 6 tumor markers for males and females, respectively. OneTest™ Premium includes the results from OneTest™ Standard, and provides an in-depth analysis of the risks for the 6 most common cancers for males and 7 for females. This is achieved by adding an additional 6 markers for males and 5 for females.
Questions about Testing
I received my OneTest™ kit in the mail. How should I proceed?
Your order should arrive within 7 days from placing your order. When your test kit arrives, you should remove the two ice packs from the inner box and put them in the freezer. The ice packs need at least 2 days to completely freeze.
Before you submit your sample, you will need to register your OneTest™ kit to a OneTest™ account. Please read through and follow the instructions of our Portal Registration Guide.
The following specimen and collection instructions are shipped with your OneTest™ kit, but can also be downloaded below.
What blood draw options do you offer?
OneTest now provides two options for blood draw services:
- OneTest now offers at-home collection, requiring only a small blood sample. With new FDA-approved devices, nearly pain-free capillary collection is now possible from the comfort of your home.
- Traditional venous blood draw, available either through your personal healthcare provider or at one of our affiliated medical access points, including My One Medical Source and AnyLabTestNow.
Your doctor’s office may have someone who can draw your sample. If your physician’s office does not offer blood draw services, you will need to have a local provider to draw your blood sample. We have partnered with two national companies, My One Medical Source (MOMS) and AnyLabTestNow (ALTN), that offer blood draw services, for an extra fee. You may also be able to find a local lab service center who can provide blood draw services
How do I return the collection kit after my blood draw?
When you have your blood sample drawn, please request that the lab will ship your sample out the same day. A pre-paid FedEx Overnight shipping label is included in your test kit.
OneTest™ Standard samples must be shipped out so that they are received at the lab within 3 days (72 hours) of being drawn. Please avoid shipping samples on Fridays or before holidays to avoid them being in transit for 3 days or more.
OneTest™ Premium samples must be shipped out so that they are received at the lab within 2 days (48 hours) of being drawn. Please avoid shipping samples on Thursday and Fridays or before holidays to avoid them being in transit for 2 days or more.
How do I schedule my blood draw appointment?
After purchasing the telemedicine service, you will receive a pre-authorized signed requisition form in your OneTest™ kit. Our telemedicine provider will reach out to discuss results once they are finalized.
I purchased telemed authorization. What do I do now?
No, you are not required to fast before the blood draw.
Do I need to fast before the blood draw?
OneTest™ Standard and OneTest™ Premium can only predict cancer risk for a 12 month period subsequent to testing and therefore are most effective when used on a yearly basis. While our current tests can only give you a snapshot of your current risk, your first test will also provide a baseline of your cancer biomarker values. Annual testing may help identify significant changes in cancer biomarkers which may be due to a developing tumor. Baseline biomarker values, together with recent changes in those values and factors such as age, family cancer history, and environment/occupational exposures may be considered when determining a personalized plan for testing frequency.
Questions about Results
What do my results mean?
Download the OneTest™ Explanatory Pages for a document explaining the various parts of the OneTest™ report. This document is also available on our patient portal.
We do not offer medical advice to patients regarding test results. Please contact your healthcare professional for a clinical interpretation of OneTest™ results and recommendations for next steps for additional testing.
Our telemedicine partners offer an in-depth consultation to discuss test results. If you are interested, please contact support@mdintegrations.com and their support team will set up a consult for the call and collect additional payment.
How do I interpret my OneTest™ Standard report?
Low Risk
The OneTest™ algorithm analyzed your biomarkers based on a dataset of >27,000 asymptomatic individuals who were followed for at least one year after testing. Only 0.3% of individuals in our dataset with biomarker patterns similar to yours were diagnosed with cancer within one year of having their biomarkers tested. This places you in a low-risk category.
Mild Risk
The OneTest™ algorithm analyzed your biomarkers based on a dataset of >27,000 asymptomatic individuals who were followed for at least one year after testing. 2.2% of individuals in our dataset with biomarker patterns similar to yours were diagnosed with cancer within one year of having their biomarkers tested and the mean time to diagnosis was ~5 months. This places you in a mildly elevated risk category.
Moderate Risk
The OneTest™ algorithm analyzed your biomarkers based on a dataset of >27,000 asymptomatic individuals who were followed for at least one year after testing. 10.2% of individuals in our dataset with biomarker patterns similar to yours were diagnosed with cancer within one year of having their biomarkers tested and the mean time to diagnosis was less than 3 months. This places you in a moderately elevated risk category.
How do I interpret my OneTest™ Premium report?
OneTest™ Premium customers will receive both OneTest™ Standard and OneTest™ Premium reports.
For each of the tested cancers, OneTest™ Premium reports elevated risk of cancer. Based on the real-world validation study, the table on the previous page reports the percentage of individuals in the study who were identified as having “elevated risk” and whom subsequently were actually diagnosed with cancer. These percentages indicate the risk associated with your elevated OneTest™ Premium predictions. Often OneTest™ Premium will indicate elevated risk for more than one cancer type. This is because there is crossover in the biomarkers used in the different algorithms. Each algorithm should be interpreted separately and follow-up for elevated risk categorizations should be according to standards of care for the indicated cancer type.