Healthcare Providers

Patient Guiding Handbook for Healthcare Professionals

Spot early signals of common and aggressive cancers using
next-generation of ctDNA technology

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Patient Guiding Handbook for Healthcare Professionals 19.45 MB 235 downloads

Spot early signals of common and aggressive cancers using next-generation of ctDNA...
Find out:

Why is cancer screening important?

Early detection is the key to save lives.

We fear cancer. We fear the risks we think we can’t control

Cancer is uniquely frightening. Despite significant advancements in cancer treatment, it remains the leading cause of death worldwide. Unfortunately, a majority of the public still believes that a cancer diagnosis inevitably leads to death. However, this perception is often due to late-stage detection rather than a lack of progress in treatment.(1)
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new cases each day in South-East Asia.
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More than 70% of cancers in low–income and middle–income Asian countries are diagnosed in late stage.(1)

But we can control, and we should not fear

The answer is in the matter of time. Cancer doesn’t wait. The sooner cancer is detected, the better treatment outcomes will be.

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Survival rate if detected early.(2)
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Breast and Colorectal cancers have >90% survival rate if detected early.(2)
X2 - X 0
Less expensive treatment if diagnosed early.(3)
  • (1) Sankaranarayanan, R., Ramadas, K., Qiao, Y., 2014. Managing the changing burden of cancer in Asia. BMC Med 12, 3
  • (2) Statistics adapted from the American Cancer Society’s (ACS) publication, Cancer Facts & Figures 2022 and Cancer Facts & Figures 2021; the ACS website; and the International Agency for Cancer Research website. (All sources accessed January 2022.)
  • (3) UN & WHO: Early cancer diagnosis, better trained medics can save lives, money

How to improve our chances of early detection?

How does
SPOT-MAS test work?

SPOT-MAS test is based on a scientific discovery of DNA fragments from tumor cells that are released into the bloodstream.

These DNA fragments are called circulating tumor DNA,
or ctDNA.

Find out:

Scope of testing (1)

Basic Option: Top 05 Common Cancers

Extended option: 05 Less Common But Aggressive Cancers

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currently have no standard-of-care screening program available.(2)

These cancers accounted for 56.2% of total new incidences and 59.9% of total mortality in South-East Asia.(3)

  • (1) The number of cancer types varies based on availability in different countries.
  • (2) according to WHO, American Cancer Society 2024 and USPSTF recommendations.
  • (3) GLOBOCAN WHO – SEA report 2022

SPOT-MAS test clinical validated performance

Sensitivity
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Sensitivity depends on the stage of the cancer
Stage I & II
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Stage IIIA
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Specificity
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Positive Predictive Value
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Positive predictive value varies with risk factors
High risk
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Age ≥ 50
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Male
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Negative Predictive Value
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Tissue Of Origin Prediction Accuracy
Volunteers participated in the case-control study
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A case-control study of 1,550 healthy participants and 738 patients with primary cancers of the breast, lung, liver, colorectal, and stomach. Evaluation of the sensitivity, specificity and predictability of the tumor origin of the SPOT-MAS test. (1)
Volunteers participated in the cohort study
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Cohort study of 9,024 healthy participants. Patients with a positive SPOT-MAS result are recommended to undergo cancer diagnostic testing. Cases with negative SPOT-MAS results are followed up after 6-12 months. (2)

Who is
SPOT-MAS for?

MCED tests are often prohibitively expensive, but if appropriately priced for low- and middle-income countries, assays such as SPOT-MAS have the real potential to enable early detection, particularly where national cancer screening programs are not available.

Patients

The test is Rx only.

A medical prescription and a signed consent form are needed.

SPOT-MAS are NOT for people who:

  1. Have been diagnosed with cancer within 5 years
  2. Have suspected signs and symptoms of cancer (unexplained weight loss, pain does not help with medication, bleeding or abnormal discharge in the nipple, prolonged cough, disorders of bowel movements)
  3. Are pregnant
  4. Have a history of bone marrow transplant or whole blood transfusion within 3 months
Overall process of multi-cancer early detection

A positive result (ctDNA signal detected) does NOT COMPLETELY confirm that a test participant has cancer because some special pathological conditions can cause “pseudo” ctDNA signal.

A negative result (no ctDNA signal detected) does NOT COMPLETELY rule out the presence of cancer because

  • The tumor is out of screening scope.
  • Rare tumors located in an anatomic location rarely sheds ctDNA
  • Rare advanced metastatic cancers with methylation changes are completely different from the primary cancer
TEST PERFORMANCE % INTERPRETATION
Positive Predictive Value 58.1% In every 100 positive cases, about 58 cases actually have cancer
Negative Predictive Value 99.9% In every 100 negative cases, about 99 cases actually do not have cancer
Accuracy of Tumor Origin Prediction 84.0% Probability of primary tumor location prediction based on bioinformatics models

Key recommendations:

  • The SPOT-MAS test does not detect all cancers.
  • False positive and false negative results can occur.
  • A positive result requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging and/or tissue biopsy) to confirm cancer.

What to do with the results?

03 possible results after ctDNA analysis

  • TM – target methylation density
  • GWM – genome-wide methylation density
  • CNA – copy number aberration
  • FLEN – fragment length distribution
  • EM – 4 mer end motif

Positive Result – Recommended diagnostic resolution

TUMOR ORIGIN PREDICTIONRECOMMENDED DIAGNOSTIC IMAGING TESTS
BreastBreast ultrasound combine with mammography OR breast MRI (if mammogram was taken within 3 months)
Liver3 phases abdominal CT scan
LungChest CT scan with contrast
ColorectumColonoscopy
StomachUpper endoscopy
05 extended cancers: Esophagus, Pancreas, Ovary, Uterine, Biliary tractChest and abdominal CT scan with contrast (if customer is female, add transvaginal ultrasound)
Other organsWhole body CT scan (if customer is female, add breast MRI)

How does SPOT-MAS test work

Adults aged 
less than 40 years 
but have high risks

  1. Heavy smoking
People who have a 20 pack–year history 
of smoking.(1)
  2. Heavy drinking
People who drink 15 cans of beer a week (for men) or 08 cans of beer a week 
(for women).(2)
  3. Hereditary risks
Those who have had tested positive for inherited cancer genes such as BRCA1, BRCA2, TP53.(3)
  4. Liver diseases
People who have Hepatitis B or C.(4)
  5. Familial history People whose family members had been diagnosed with cancer.(5)
(1) Chen et al., 2021. American Journal of Otolaryngology 42, 102915. (2) Connor et al., 2017. Addiction 112, 222–228. (3) Garber et al., 2005. JCO 23, 276–292. (4) Petruzziello et al., 2018. TOVJ 12, 26–32. (5) Brewer et al., 2017. Breast Cancer Res Treat 165, 193–200. 

Adults aged 
less than 40 years 
but have high risks

The likelihood of cancer has increased since 1990. Older persons are at higher risk for cancer.(1)
Globally, breast cancer screening is recommended for women above 40 years old(2). Some countries recommend to screen for colon(3), stomach(4), lung(5), and liver(6) starting from as early as 40 years old.​
(1) Sharma et al., 2024. The Lancet Regional Health – Southeast Asia 21, 100333.  (2) Renet al., 2022. The Breast 64, 85–99.  (3) Azad NS et al., 2020. Prev Med. 2020;133:106003. (4) Mabe et al., 2022. Digestive Endoscopy 34, 412–419.  (5) Nawa et al., 2019. Japanese Journal of Clinical Oncology 49, 130–136. (6) Lee et al., 2014. Cancer Res Treat 46, 223–233. 

Negative Result – Next actions

Intermediate Result – Next actions

Positive Result – Next actions

Patient Support Programs are available for positive results.
  1. For patients with a Positive test result, partial reimbursement for follow-up diagnostic tests is available.
  2. Free-of-charge ctDNA re-analysis after 6 months with Positive result but:
    • No lesion detected in imaging tests OR
    • Lesion detected in imaging tests with benign pathology
  3. Free-of-charge ctDNA reanalysis within 6 months with Intermediate result

SPOT-MAS video