MULTI-CANCER EARLY DETECTION
WHAT IS ctDNA?
ctDNA (circulating tumor DNA) is DNA released from cancerous cells and tumors, circulating freely in the bloodstream.
ctDNA analysis based on NGS is a global trend in early cancer detection. It can be detected through a blood test and has been shown to be a valuable tool in early detection of cancer, especially for healthy and asymptomatic individuals.
HOW SPOT-MAS WORKS
Tumor cells (if any) in the body.
Tumor cells, as they die, release small fragments of DNA into the bloodstream, which are called “circulating tumor DNA” (ctDNA).
Drawing a sample of blood (10ml) via a Streck tube to extract "cell-free DNA" (cfDNA) from blood plasma.
Apply next-generation sequencing to detect four different features of ctDNA from tumor cells (as distinguished from cfDNA (cell-free DNA) which are released by healthy cells)
ctDNA: negative result—NO ctDNA detected
ctDNA+: positive result—ctDNA detected
The SPOT-MAS test detected signs of ctDNA associated with cancer.
If ctDNA is detected, the origin of the signs of cancer can be predicted through machine-learning algorithms modeled on more than 20,000 cases of cancer. The result will support doctors in guiding their patient's next steps.
HOW IS SPOT-MAS DIFFERENT FROM
HEREDITARY CANCER SCREENING TEST?
Hereditary cancer screening tests look for genes with mutations linked to cancer risks, and do not tell whether you have cancer at the time of testing.
WHO SHOULD TAKE THE SPOT-MAS TEST?
People aged 40 or older
Adults with an elevated risk of cancer(*) or family history of cancer(**)
NOT RECOMMENDED FOR
People with symptoms of cancer or who have been diagnosed with cancer
People with tumors/lesions that could interfere with ctDNA signals
People who have had a marrow transplant or whole blood transfusion within 3 months of the test.
*Smoking more than 20 packs per year or passive smokers; who drink more than 15 cans per week for men and eight cans per week for women; people who are constantly exposed to toxic substances or a polluted environment.
(**) Family history of having been diagnosed with cancer.
UNDERSTANDING SPOT-MAS RESULTS
The results of the SPOT-MAS test will be sent to customers within 30 days of the date your sample arrived at the Gene Solutions laboratory. The two possible test results are: “ctDNA detected” or “No ctDNA detected”:
People Aged 40 or older
Signs of ctDNA associated with tumor cancer have been detected in the blood sample.
The result will include 1-2 predictions of the origins of the tumor in the body that the cancer signal may be coming from.
The ctDNA detected in the SPOT-MAS test result is not a cancer diagnosis and requires follow-up recommended diagnostic test guidelines, such as imaging prescribed by your doctor to officially confirm a cancer diagnosis.
No ctDNA detected
The SPOT-MAS test looked for signs of cancer and did not find any at this moment.
Continue with the SPOT-MAS test or any cancer screening method every six months to one year as recommended by a healthcare professional.
Do not ignore cancer signs or symptoms if they occur, as this can lead to a delayed diagnosis.
SCREEN FOR THE FIVE COMMON TYPES OF CANCER
WITH JUST A SINGLE BLOOD SAMPLE
LIVER | BREAST | LUNG | COLORECTAL | STOMACH
SPOT-MAS (Screening for the Presence of Tumor by Methylation And Size), a multi-cancer early detection test that applies next-generation sequencing (NGS) to detect circulating tumor DNA (ctDNA) is now available at
Aegle Wellness Center
ADVANTAGES OF THE SPOT-MAS TEST
Detect five common types of cancer with just a single blood sample
The accuracy in early cancer detection and tumor origin prediction are validated in clinical studies.
The SPOT-MAS test is a supportive screening one, and does not replace current cancer screening guidelines.
Routine Screening Methods:
Breast Cancer - X-ray and Mammogram
Liver Cancer - X-ray, CT-SCAN, MRI
Lung Cancer - Low-dose CT (imaging)
Colorectal Cancer - Colonoscopy
Stomach Cancer - Gastroscopy
IMPORTANT SAFETY INFOMATION
The SPOT-MAS test is recommended for use in adults with elevated risk of cancer, such as those aged 40 years or older, those who carry genetic mutations, or those with unhealthy habits like smoking, drinking alcohol, getting hepatitis B, C. SPOT-MAS is not recommended for pregnant women or patients undergoing cancer treatment, or those with the history of bone marrow transplant, blood transfusion within 3 months.
The SPOT-MAS test is used to detect signals that suggest cancer through ctDNA released from cancer cells into the bloodstream and to predict the tumor origin of the cancer signal in the body. SPOT-MAS does not detect all cancers and not all cancers can be detected through ctDNA analysis. Therefore, SPOT-MAS should be used as recommended by the Doctor and as a supporting method for recommended routine cancer screening methods to help detect cancer EARLY.
It should be noted that SPOT-MAS is a screening test and SPOT-MAS results should be consulted by a healthcare expert, or a genetic specialist. The Doctor will interpret the results of the SPOT-MAS test based on information of your medical history, clinical symptoms, and other signals. A negative SPOT-MAS test result “no ctDNA signal detected” does not exclude all possibilities of having cancer, so it is still necessary for the routine check-up of cancer as recommended by a healthcare professional. With a positive SPOT-MAS test result “ctDNA signal detected” and the origin of cancer prediction, the Doctor will recommend follow-up diagnostic methods such as imaging, biopsy, etc. to confirm the presence of cancer. False positives and false negatives do occur.
When using SPOT-MAS tests for early cancer screening, some limitations of ctDNA analysis method released from cancer cells into peripheral blood should be kept in mind about the following results:
A negative result (no ctDNA signal yet) does not completely exclude the presence of cancer because the tumor might be out of the screening range (5 types) or located in the location where it is difficult for ctDNA to release, or the secondary cancer has completely different methylation changes than the primary cancer.
The sensitivity is 73.9%, meaning that for every 100 cases of cancer, about 26 cases will be missed. It is recommended that this test should be used as an adjunct to screening, not a substitute for current recommended routine cancer screening methods.
A positive result (ctDNA signal detected) does not completely confirm that the participant has cancer due to some special physiological or pathological circumstances can produce a “false positive” result. The specificity is 95.9%, which means that for every 100 cancer-free cases, about 4 will have positive ctDNA signals
The positive predictive value of the test is 60%, which means that for every 100 cases that are positive, 60 will have cancer. Therefore, a positive result should be consulted by an oncologist, genetic specialist and confirmed with medical imaging tests.
The tumor origin is predicted based on machine learning algorithms that analyze 4 different features of ctDNA released to the bloodstream and predict the tumor origins with the accuracy of 83.3%. However, these features of ctDNA can be duplicated leading to the inability to completely identify the tumor origin.