A Hong Kong biotechnology company, EarlyDetect Biosciences, spun out of the Chinese University of Hong Kong's Faculty of Medicine in 2021, has announced the completion of a pivotal clinical validation study demonstrating that its PanScan-14 liquid biopsy test detects 14 types of cancer from a 10-millilitre blood draw with an aggregate sensitivity of 89 percent across all cancer types and a specificity of 97 percent. The announcement coincided with the close of an 850-million-US-dollar Series C funding round led by Sequoia Capital China, with participation from Hillhouse Capital, Novartis Venture Fund and the sovereign wealth fund of Singapore.
The Technology
PanScan-14 is based on a multi-analyte approach that simultaneously analyses three distinct molecular signals in the patient's blood: circulating tumour DNA (ctDNA) methylation patterns, circulating tumour RNA expression profiles, and protein biomarker concentrations. The integration of all three signals through a proprietary machine learning model, trained on genomic data from 68,000 patients across 14 cancer types, dramatically increases sensitivity and specificity compared with single-analyte approaches that dominate the current liquid biopsy market.
The test detects the following 14 cancer types: colorectal, lung, liver, pancreatic, gastric, ovarian, breast, cervical, nasopharyngeal, oesophageal, bladder, thyroid, kidney and haematological malignancies. Of particular clinical significance is the test's 84 percent sensitivity for pancreatic cancer at stage I and II, where the cancer is potentially curable with surgery, compared with the current clinical reality in which over 80 percent of pancreatic cancers are diagnosed at stage III or IV when treatment options are severely limited.
EarlyDetect's PanScan-14 detects 14 cancer types with 89% sensitivity, including 84% sensitivity for early-stage pancreatic cancer where outcomes are significantly better.
Clinical Validation
The pivotal validation study enrolled 45,000 participants across 28 clinical sites in Hong Kong, mainland China, the United States and the United Kingdom. Participants were screened with PanScan-14 and followed for 24 months, with incident cancer diagnoses ascertained through medical record linkage and direct follow-up. The study design, methodology and results have been published simultaneously in The Lancet and have been subject to independent statistical analysis by biostatisticians at the University of Oxford.
The UK's National Institute for Health and Care Excellence has fast-tracked an assessment of PanScan-14 for potential NHS adoption, having identified multi-cancer early detection as a priority technology area. The US Food and Drug Administration has granted Breakthrough Device Designation, which expedites the review pathway for the test's US marketing authorisation application, expected to be filed before the end of the year.
Hong Kong's Biotech Ecosystem
EarlyDetect's success illustrates the maturation of Hong Kong's biotech ecosystem over the past decade. The company was built around intellectual property generated within CUHK's medical faculty, using equipment and expertise in the university's genomics and proteomics core facilities, and was nurtured through the Hong Kong Science Park's biotech incubation programme before graduating to its own 45,000-square-foot laboratory in Science Park Phase II.
EarlyDetect Biosciences raised $850M in Series C funding led by Sequoia, with the test validated across 45,000 participants at 28 clinical sites globally.
Regulatory and Commercialisation Path
EarlyDetect has received approval from Hong Kong's Department of Health to offer PanScan-14 as a laboratory-developed test through a network of 12 private hospitals and specialist clinics in Hong Kong from September 2026, priced at HK$3,800 per test. The company expects to achieve Chinese market authorisation through the National Medical Products Administration by the end of the year, opening a potential market of 1.4 billion people where cancer remains the leading cause of disease mortality.
Chief Executive Dr Karen Chan noted that the commercial opportunity is substantial: at a screening population of just 1 percent of China's adult population over 45, the potential annual test volume would exceed 3 million, generating revenue in excess of 500 million US dollars. The company's partnership with China's leading private hospital chain, to be announced formally in September, will provide the clinical distribution network needed to achieve this scale within three years of Chinese regulatory approval.