New Horizon Health Limited, a vendor in China that focuses on non-invasive colon cancer screening technology, inked an exclusive deal with Prenetics Limited, a genetics and digital health company in Asia and Europe. New Horizon will undertake a technology transfer to Prenetics for its ColoClear, non-invasive multi-target stool DNA test for colorectal cancer, developed for individuals of Asian ethnicity and, they purport, to be “validated through clinical studies to perform at 92% sensitivity in the detection of colon cancer.”

In addition to the technology transfer, Prenetics will set up a ISO-15189  accredited, dedicated colon cancer detection service facility in Hong Kong by early 2020 and another one in Southeast Asia later in the year.

Non-Invasive Colon Cancer Detection: Who is New Horizon Health Limited?

Based in Hangzhou, China (near Shanghai), New Horizon Health Limited was founded in 2013 with a mission to make non-invasive, DNA test-based colon cancer detection technology available. They believe their ColoClear “is a true technology Game Changer in terms of performance” and that can be accessible to million of people throughout the Asian continent.

The venture has raised $86 million according to CrunchBase involving 12 investors in at least three rounds. Its founders include Ning LuYeqing Zhu, CEO, and Yiyou Chen. Mr. Zhu worked for GE Capital in China for several years undoubtedly affording him access to significant financial networks in China while Mr. Chen earned his PhD from the University of Utah in experimental pathology.

Importantly the company has declared that the technology has been “validated” in clinical trials.  A basic search was conducted and we couldn’t identify any studies published in Clinicaltrials.gov that included New Horizon as a sponsor. That doesn’t mean that their claim isn’t accurate, however we cannot verify it for this article.

They are on a mission to identify colon cancer earlier in patients throughout Asia. The hope is that this arrangement with Prenetics Limited will accelerate that process. 

Enter Prenetics Limited—the Commercialization Channel

Prenetics positions itself as a leading genetic testing/digital health company operating in Southeast Asia. Founded in 2009, they have raised $52.7 million. At its core, it is a genetic testing lab venture. Backed by a group of prominent Chinese investors, such as Alibaba Hong Kong Entrepreneurs Fund to Ping An Insurance, they seek to “empower individuals with valuable health information” via various genetic testing products.

CEO Danny Yeung appears to be a hard-charging, ambitious entrepreneur with a significant and successful track record.

They utilize DNA  testing technology and own and operate a DNA laboratory with what they purport run under “international quality standards” with “effective protocols” for handling samples associated with the DNA test process.  On their website they declare that the technology has been validated for 99.9% accuracy by Genome Sequencing Laboratory (CFGSL). Their current products include, according to their website, Nutrigenomics, Pharmacogenomics, Inherited Cancer Screen and Family Planning Screen.

Direct to Consumer

In 2018, Prenetics acquired the UK’s DNAFit to move into consumer services. Valued at approximately $10 million, according to TechCrunch sources, it not only opened up new geographies for Prenetics but also expanded the scope of available services. As was reported, Prenetics was designed initially around facilitating health payer (insurance) and physicians for use of the service for their clients and patients. With the DNAFit deal, they could now market services direct to consume much like 23andMe

Digital Health in Asia and Relevance to Clinical Research Sponsors

Asia, the world’s most populated continent, is important for the world of clinical trials and new treatments. China has emerged as the world’s second largest economy and is home to a growing middle class. The world’s biggest biopharmaceutical companies invest heavily there to ultimately position for growth and prosperity. With the advent of new technologies, services and the move to patient-centric modes of research, digital health ventures that involve DNA genetic testing services are an important channel for clinical research participants. That is why GSK paid 23andMe $300 million for a drug discovery and development partnership. With access to 5 million consumers DNA test results, the clinical sponsor saw potential gold. 

Hence why TrialSite News monitors arrangements such as the one covered herein. With a rapidly rising middle class comes an increase in colon cancer incidents and hence potential demand for the combined offering of New Horizon/Prenetics. A number of milestones will need to be met for the New Horizon and Prenetics partnership to take off. First and foremost, the “ColoClear” technology needs to meet rigorous standards (e.g. government agency authorized approvals based on GcP-based clinical trials) for the term “Validated” to be accurate. Second, Prenetics must successfully execute to capitalize on the growing demand for genetic testing and related services in Asian markets as the focus is on Asian-ethnic-centric early-detection of colon cancer. Third, the parties must be able to execute for scale. None of this is easy. For the second point—demand—Prenetics is entering into deals, such as with Hong Kong-based Watson Group, in an attempt to more rapidly tap into nascent consumer demand for digital health services such as genetic testing.

Source: BioSpectrum

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