appConfigEntityId

bodyType

customContents

entityId

entityUuid

isVideo

articlePageQuery

article

articleSchemaContent

content

hooksArticlePageAdvertisementConfigArticle

hooksArticlePageFloatingButtonConfigArticle

appConfig

filter

json

liveArticle

Eric Ng

Cancer screening device developer Mirxes Holding has won approval from Beijing to launch a gastric cancer test, the first blood test for the disease in China’s vast oncology diagnostics market.
Its leading product, GastroClear, an in-house-developed non-invasive blood test, was approved by the National Medical Products Administration of China, the Singapore-based micro ribonucleic acid (miRNA) technology firm said in a filing to Hong Kong’s stock exchange on Thursday.
“GastroClear is the world’s first microRNA blood test approved for the early detection of gastric cancer, evaluating gastric cancer risk by detecting 12 gastric cancer-associated miRNA biomarkers,” it said.
“The company will continue to expand its investment in scaling commercialisation in China, including increasing the size of its sales team and enhancing local production capacity.”

Gastric cancer was the fifth leading cause of cancer deaths in 2023 globally, and ranked fifth in terms of global incidences that totalled around 1 million among all new cancer cases reported that year, according to Frost & Sullivan.
The combined gastric cancer screening market in China, Japan, Southeast Asia and the US grew by an average annual rate of 4.1 per cent to US$15.2 billion from 2019 to 2023, and was forecast to expand to US$25.4 billion by 2033, Mirxes’ listing prospectus said, citing the market research firm.
The approval was for screening of adults aged 45 to 74 who faced a high risk for gastric cancer, as defined in cancer diagnosis and treatment guidelines published by the Chinese health authorities last year.
This meant the test’s addressable market could exceed 500 million individuals, Mirxes said, adding it would target both public and private medical institutions.
The product, which tests for 12 miRNA biomarkers, was launched in Singapore in late 2019 and in Thailand last December. MiRNAs are molecules vital to many cellular processes.
MiRNA-based liquid biopsy costs US$150-US$350, compared with US$600-US$2,000 for a tumour DNA-based test, according to Frost & Sullivan. Both can detect early-stage cancers. GastroClear can correctly identify those with stage-one gastric cancer 87.5 per cent of the time and can accurately identify those without the disease 68.4 per cent of the time, according to Mirxes’ prospectus.
With no immediate plan to seek European approval, Mirxes said in May when it went public that it would initiate consultation in this year’s second-half with the US Food and Drug Administration (FDA) about the clinical trial design required for US approval.
In 2023, the test received “breakthrough device” designation from the US FDA. Signifying the agency’s recognition of its potential to provide more effective diagnosis for life-threatening conditions, the designation affords it faster regulatory review.
For its lung cancer blood test candidate, Mirxes said at the time it won approval and launched in 2022 a test under the condition that it be processed by a single laboratory in Singapore, to serve customers in Southeast Asia and Japan. It had aimed to start clinical trials in this year’s first half and obtain approval for it to be processed by many more laboratories by the second half of 2027.
Other tests for colorectal, liver and breast cancers were in early-stage research.
Established in 2014, the company focused on the Asia market, particularly Singapore and China. It posted a net loss of US$35.1 million for this year’s first half. Revenues grew 9.4 per cent year on year to US$10.47 million.
Shares of Mirxes traded 4.96 per cent lower at HK$70 at the close on Thursday. The stock has rallied over three-fold from its initial public offering price of HK$23.30 in May. The firm warned in May that the high concentration of its shareholding by a small number of owners could move its share price substantially even on low trading volume.


GSK licenses Chinese firm’s cancer drug in US$750 million deal

Data from Greater Bay Area’s 88 million residents to help improve healthcare policy: GSK

Hong Kong watchdog investigates Cloudbreak Pharma for ‘rigged’ IPO, suspends its shares

Hong Kong targets biomedicine powerhouse status in debut 5-year plan

Biomedicine: Companies

Mirxes wins China’s approval to launch groundbreaking blood test for gastric cancer

GastroClear, the first microRNA blood test approved in China for the early detection of gastric cancer, evaluates risks by detecting 12 miRNA biomarkers, according to developer Mirxes. Photo: Handout

 GastroClear has been approved for screening of adults aged 45 to 74. Photo: Handout

Temasek unit-backed firm Lucence to tap Hong Kong cancer screening market

The Lucence liquid biopsy test costs more than US$1,000, which represents just 10 per cent to 20 per cent of the cost of a tissue biopsy, according to its founder. Photo: Shutterstock

Chief Executive Officer & Medical Director of Lucence Diagnostics, Tan Min-han photographed in Tai Koo. 24APR19 SCMP / Xiaomei Chen

Hong Kong’s Phase Scientific gets US$34 million to advance test for cancer risk factor HPV

Ricky Chiu Yin-to, founder, chairman and CEO of Hong Kong biotech company Phase Scientific. Photo: Handout

A person walks at the Hong Kong Science and Technology Park on August 9, 2024. Photo: Reuters

Chinese scientists achieve breakthrough in early detection of ‘king cancer’ that killed Steve Jobs

A breakthrough method of early screening for pancreatic cancer, which combines medical imaging with an AI algorithm, could help save thousands of lives each year. Photo: Shutterstock

Apple co-founder Steve Jobs died at the age of 56 from pancreatic cancer, which is notoriously difficult to detect. Photo: AP

Hong Kong to launch second phase of free breast cancer screenings on June 10

A free mammography service will be provided at seven clinics run by the Hong Kong Breast Cancer Foundation, United Christian Nethersole Community Health Service and Haven of Hope across the city. Photo: Dickson Lee

Dr Anne Chee says “thousands” are expected to benefit from this phase because just those at high risk are eligible for the free screenings. Photo: Edmond So

Mirxes advances RNA technology to diminish the economic burden of cancer

Zhou Lihan, co-founder and CEO

Mirxes’ industry-leading RT-qPCR platform for detection of microRNAs and other non-coding RNAs powers its flagship GASTROClear gastric cancer early detection test and is the foundation on which its multi-cancer early detection clinical pipeline is built.

Mirxes’ purpose-built multi-omics laboratory at Singapore’s Biopolis houses the cutting-edge T10 Genetic Sequencing System, the world’s largest and highest throughput next generation sequencer.

Discovery Reports

Business

News

China Future Tech

Biomedicine

The non-invasive blood test helps in the early detection of the fifth leading cause of cancer deaths globally


The non-invasive blood test helps in the early detection of the fifth leading cause of cancer deaths globally.


Mirxes wins China’s approval to launch groundbreaking blood test for gastric cancer

.css-1c6uqr6{color:inherit;font-weight:inherit;font-size:inherit;font-family:inherit;line-height:inherit;overflow-wrap:break-word;}The non-invasive blood test helps in the early detection of the fifth leading cause of cancer deaths globally

The non-invasive blood test helps in the early detection of the fifth leading cause of cancer deaths globally