Image 1. Illustration of cell-free DNA in the blood stream (Shutterstock)

PR99619

HO CHI MINH CITY, Vietnam, April 25, 2023 /PRNewswire=KYODO JBN/ --

In January 2023, Vietnam's Medical Genetics Institute & Gene Solutions

(https://genesolutions.com/) published their research paper on Cancer

Investigation: Clinical validation of a ctDNA-based assay for multi-cancer

detection: an interim report from a Vietnamese longitudinal prospective cohort

study of 2,795 participants.(*)

Circulating tumor DNA, or cell-free tumor DNA (ctDNA) assay is based on

detecting the appearance of ctDNA in blood. This method is sometimes called

Liquid Biopsy as it only requires blood sample collection, rather than tumor

tissues. Theoretically, all cells release their cell-free DNA in the blood

stream, including tumor cells. The characterization and sequencing ability to

detect these ctDNA have been applied into multiple purposes including profiling

tumor mutations, monitoring treatment responses, especially early cancer

detection for asymptomatic individuals.

There are several assays of liquid-biopsy-based early cancer screening

worldwide. However, each uses different signatures on ctDNA. Overall, these

tests can simultaneously detect multiple cancer types (from 8 to 50), showing

specificity above 95% while sensitivity varies from 44% to 98% depending on

cancer types and disease stages. However, none of these studies was designed

for Southeast Asia landscape.

Founded in Vietnam, Gene Solutions (https://genesolutions.com/) developed a

multimodal liquid biopsy based assay named Screening for the Presence Of Tumor

by Methylation And Size (SPOT-MAS) to detect the five most common cancer types

(liver, breast, colorectal, gastric, and lung cancer).

In April 2022, the first analytical validation of SPOT-MAS test was conducted

on a cohort of 285 patients and 222 healthy individuals. This proved SPOT-MAS'

ability to detect cancer patients with a sensitivity of 73.9% and a specificity

of 95.9%. (**)

Later, a second clinical validation study was conducted to assess the

feasibility and performance of SPOT-MAS in a multi-center clinical trial

setting. Gene Solutions launched a prospective cohort study named K-DETEK at 13

major hospitals and one research institute in Vietnam.

The interim analysis of 2,795 eligible asymptomatic participants (6 months from

initiation) showed the feasibility of SPOT-MAS for testing samples collected

from multiple clinical sites and proved its ability to detect cancer in healthy

participants at early stages. The report detected 13 cases (0.47%) with ctDNA

signal and demonstrates a positive predictive value of 60%, with 83.3% accuracy

in detecting tumor location.

The researchers also presented a notable case report to support further using

SPOT-MAS as a complementary method to detect cancer and provide the opportunity

for early treatment. The patient had no warning symptoms of cancer, no history

of cancer, and no family history related to cancer. He voluntarily joined the

study in June 2022 and took the SPOT-MAS test. One month later, his report

showed that "ctDNA signal is detected," predicting the possibility of ctDNA

from liver cancer (75%) and/or colorectal cancer (23%). He was immediately

informed and underwent diagnostic tests for liver cancer within a month. The

ultrasound revealed a tumor at the lower segment of the liver, suggesting Stage

IB hepatocellular carcinoma (HCC). After these results were carefully reviewed

and discussed, the patient was transferred to an oncologist for minimally

invasive treatment by a combination of TACE and RFA, a non-surgical optimized

method with good efficacy and safety suitable only for patients with

early-stage tumors. After receiving treatment, he was scheduled for a follow-up

at 12 months from the study baseline.

The performance of SPOT-MAS demonstrated in this study enables the research

group to be optimistic that within the next 5 years, SPOT-MAS will be available

in clinical practices and implemented in screening programs across multiple

nations – alongside other routine screening tests.

As Gene Solutions (https://genesolutions.com/) is expanding to Thailand,

Indonesia and the Philippines, it is expected that the firm will open more

ctDNA clinical validation in each country to further demonstrate the

performance of SPOT-MAS and open new personalized screening method in the fight

against cancer.

***

Sources:

(*) Taylor & Francis Online – Cancer Investigation

(https://www.tandfonline.com/doi/full/10.1080/07357907.2023.2173773）;

(**) Vietnam Medical Journal (https://doi.org/10.51298/vmj.v513i1.2360)

***

Contact:

ngoctran1@genesolutions.vn

hoanghac@mekongcapital.com

SOURCE: Gene Solutions

Image Attachments Links:

   Link: https://iop.asianetnews.net/view-attachment?attach-id=438163

   Caption: Image 1. Illustration of cell-free DNA in the blood stream (Shutterstock)

   Link: https://iop.asianetnews.net/view-attachment?attach-id=438175

   Caption: Image 2. Discussion on the testing result (Gene Solutions)