Making cell-free DNA testing accessible to all healthcare providers
A multi cancer early detection test uses next generation sequencing to detect ctDNA from the tumor cells

A multi cancer early detection test uses next generation sequencing to detect ctDNA from the tumor cells

Region's largest clinical validation for multimodal analysis in plasma cell-free DNA to detect signal of circulating tumor DNA and predict tumor location.(*)

Screening for the five most common types of cancer (liver, breast, lung, colorectal and stomach) from a single blood sample.

(*) L.S. Tran, “Clinical validation of a ctDNA-based assay for multi-cancer detection: An interim report from a Vietnamese longitudinal prospective cohort study of 2795 participants.” (ASCO Publications, JCO Global Oncology, 2023)
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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.

ctDNA can be detected through a blood test and has been shown to be a valuable tool in the cancer early detection, especially for those healthy and asymptomatic.

How SPOT-MAS works

1

Cancerous cells are formed in the tumor.

Cancerous cells are formed in the tumor.

Cancerous cells are formed in the tumor.

2

Tumor cells release DNA fragments to the bloodstream, called circulating tumor DNA (ctDNA).

Tumor cells release DNA fragments to the bloodstream, called circulating tumor DNA (ctDNA).

Tumor cells release DNA fragments to the bloodstream, called circulating tumor DNA (ctDNA).

3

Draw a blood sample (10ml) to extract cell-free DNA from plasma.

Draw a blood sample (10ml) to extract cell-free DNA from plasma.

Draw a blood sample (10ml) to extract cell-free DNA from plasma.

4

Apply next-generation sequencing to detect 5 different features of ctDNA from tumor cells compared with cfDNA from normal cells ctDNA detected: SPOT-MAS test detected a ctDNA signal associated with cancer. No ctDNA detected: The SPOT-MAS test looked for a cancer signal and did not find one at this moment.5 features: genome-wide methylation changes (GWM), methylation changes at 450 target regions,distinct size, copy number alterations (CNA), end - motif (EM)

Apply next-generation sequencing to detect 5 different features of ctDNA from tumor cells compared with cfDNA from normal cells

  • ctDNA detected: SPOT-MAS test detected a ctDNA signal associated with cancer.
  • No ctDNA detected: The SPOT-MAS test looked for a cancer signal and did not find one at this moment.
5 features: genome-wide methylation changes (GWM), methylation changes at 450 target regions,distinct size, copy number alterations (CNA), end - motif (EM)

Apply next-generation sequencing to detect 5 different features of ctDNA from tumor cells compared with cfDNA from normal cells ctDNA detected: SPOT-MAS test detected a ctDNA signal associated with cancer. No ctDNA detected: The SPOT-MAS test looked for a cancer signal and did not find one at this moment.5 features: genome-wide methylation changes (GWM), methylation changes at 450 target regions,distinct size, copy number alterations (CNA), end - motif (EM)

5

ctDNA is detected will be co-analysis with prediction of tumor origins in the scope of 5 cancers, based on advance machine learning data, to guide the further steps for doctors.

ctDNA is detected will be co-analysis with prediction of tumor origins in the scope of 5 cancers, based on advance machine learning data, to guide the further steps for doctors.

Understanding the results of SPOT-MAS

SPOT-MAS test result will be notified to customers after 12 - 20 days from the day when Gene Solutions' lab received the blood sample. Test results will showcase 2 possibilities.

Positive: ctDNA signal detected

ctDNA signal associated with tumor cancer is detected in the blood. The result will include 1-2 predictions of the origins of tumor in the body that the cancer signal may be coming from.

Next step:

The ctDNA detected as cancer signal detected in the SPOT-MAS test result is not a cancer diagnosis and requires follow-up recommended diagnostic tests in guidelines, such as imaging ordered by your doctor to confirm cancer officially.

Negative: No ctDNA signal detected

ctDNA is not detected at the time SPOT-MAS test is conducted (This test only screens for ctDNA in the testing range of 5 cancer types and does not assess the risk for having cancer in the future).

Next step:

Continue with the SPOT-MAS test or any cancer screening every 6 months - 1 year as recommended by the healthcare expert. Do not ignore cancer signs or symptoms if they occur, as this could lead to a delayed diagnosis.

How is SPOT-MAS different from hereditary cancer screening tests?

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.

Scientific evidence

Clinical validation of SPOT-MAS, Cancer Investigation, 2023
Clinical validation of SPOT-MAS, Cancer Investigation, 2023
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Clinical validation of SPOT-MAS, Cancer Investigation, 2023
cfDNA enabling large-scale profile of lung cancer patients, Frontiers in Oncology, 2020
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Clinical validation of SPOT-MAS, Cancer Investigation, 2023
Liquid-biopsy and ctDNA methylation, PLOS ONE, 2019
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What experts say

spotmas.clinical_resources.publication.pub_1

Tran Le Son, Ph.D.

ctDNA technology enables multi-cancer early detection (MCED) through a single blood draw. Non-invasive, convenient, accurate and accessible, the test is very promising in opening a new era in the world's fight against cancer.

Clinical validation of SPOT-MAS, Cancer Investigation, 2023

Nguyen Duy Sinh, Ph.D., MD

Cancer cells may develop so silently within our body for as long as 12 years without patients being aware of any symptom, until it is too late. Therefore, detecting cancer at early stages determines the efficacy of treatment.

Advantages of the SPOT-MAS test

Detect

Detect

of the most common types of cancer

Breast cancer
Breast
Liver cancer
Liver
Lung cancer
Lung
Colorectal cancer
Colorectal
Stomach cancer
Stomach
Proven

Proven

accuracy

The accuracy in early cancer detection and tumor origin prediction are validated in clinical studies.

The licensed SPOT-MAS test is a supportive screening one, and does not replace current cancer screening guidelines.

The licensed SPOT-MAS test is a supportive screening one, and does not replace current cancer screening guidelines.

Routine screening methods:

Breast cancer
Breast cancer

X-ray & Mammogram

Liver cancer
Liver cancer

X-ray, CT-SCAN, MRI

Lung cancer
Lung cancer

Low-dose CT (imaging)

Colorectal cancer
Colorectal cancer

Colonoscopy

Stomach cancer
Stomach cancer

Gastroscopy

* If you would like to know more about these tests, please contact nearby hospitals or clinics for more details.

Who should take the SPOT-MAS test?

Recommended for:

Recommended for:

People Aged 40 or older
People Aged 40 or older
Adults with an elevated risk of cancer(*) or family history of cancer(**)
Adults with an elevated risk of cancer(*) or family history of cancer(**)
Not recommended for:

Not recommended for:

Pregnant women
Pregnant women
People with symptoms of cancer or who have been diagnosed with cancer
People with symptoms of cancer or who have been diagnosed with cancer
People with tumors/lesions that could interfere with ctDNA signals
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.
People who have had a marrow transplant or whole blood transfusion within 3 months of the test.
(*) Smoking more than 20 packs/year or passive smokers;
who drink more than 15 cans/week for men and eight cans/week for women;
people who are constantly exposed to toxic substances or a polluted environment.
(**) Family history of having been diagnosed with cancer.
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 72.4%, meaning that for every 100 cases of cancer, about 28 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 97%, which means that for every 100 cancer-free cases, about 3 will have positive to ctDNA signals.The positive predictive value of the test is 58.1%, which means that for every 100 cases that are positive, 58 will have cancerous or precancerous lesions. A positive result should be evaluated by an oncologist and confirmed by diagnostic 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 84%. However, these features of ctDNA can be duplicated leading to the inability to completely identify the tumor origin.

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.

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 72.4%, meaning that for every 100 cases of cancer, about 28 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 97%, which means that for every 100 cancer-free cases, about 3 will have positive to ctDNA signals.The positive predictive value of the test is 58.1%, which means that for every 100 cases that are positive, 58 will have cancerous or precancerous lesions. A positive result should be evaluated by an oncologist and confirmed by diagnostic 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 84%. However, these features of ctDNA can be duplicated leading to the inability to completely identify the tumor origin.

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.

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 72.4%, meaning that for every 100 cases of cancer, about 28 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 97%, which means that for every 100 cancer-free cases, about 3 will have positive to ctDNA signals.The positive predictive value of the test is 58.1%, which means that for every 100 cases that are positive, 58 will have cancerous or precancerous lesions. A positive result should be evaluated by an oncologist and confirmed by diagnostic 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 84%. However, these features of ctDNA can be duplicated leading to the inability to completely identify the tumor origin.

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 72.4%, meaning that for every 100 cases of cancer, about 28 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 97%, which means that for every 100 cancer-free cases, about 3 will have positive to ctDNA signals.The positive predictive value of the test is 58.1%, which means that for every 100 cases that are positive, 58 will have cancerous or precancerous lesions. A positive result should be evaluated by an oncologist and confirmed by diagnostic 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 84%. However, these features of ctDNA can be duplicated leading to the inability to completely identify the tumor origin.

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 72.4%, meaning that for every 100 cases of cancer, about 28 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 97%, which means that for every 100 cancer-free cases, about 3 will have positive to ctDNA signals.
  • The positive predictive value of the test is 58.1%, which means that for every 100 cases that are positive, 58 will have cancerous or precancerous lesions. A positive result should be evaluated by an oncologist and confirmed by diagnostic 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 84%. However, these features of ctDNA can be duplicated leading to the inability to completely identify the tumor origin.