The story begins in June when Harbinger Health unveiled the performance data for its in-house testing at the American Society of Clinical Oncology (ASCO) annual meeting. The results were astounding, achieving an average sensitivity of 82% while maintaining 95% specificity, all while preserving tissue traceability. What’s even more astonishing is that its sensitivity for early-stage tumor detection doesn’t sharply decline like other multi-cancer early detection (MCED) methods: for stage II cases, the sensitivity is 84%, and for stage I cancer, the sensitivity remains at 74%. These findings suggest that its testing performance is on par with Grail’s Galleri, which was launched in 2021.
From the three abstracts they presented, we can summarize key information:
In late July, ADLM also expressed recognition of the HarbingerHx platform and featured it in a poster presentation.
Initially, this matter caught everyone’s attention, but as we know, the industry often witnesses promising technologies that may take several years of effort to transition from novelty to commercial viability. Additionally, some may not survive the journey. Moreover, Harbinger Health, despite its founding in 2021, has been quietly developing and is relatively lesser-known in the public eye.
But last week, this seasoned player in the early screening field underwent a remarkable transformation. They revealed their ambitious plan to enroll over 10,000 participants in a prospective study, expected to conclude recruitment by the end of the year. Their intention is to follow a path similar to Galleri’s, aiming to commercialize as an LDT (Laboratory Developed Test) by 2025! Subsequently, they plan to leverage the real-world data accumulated during the LDT phase to seek FDA approval for early screening!
What’s going on here? In June, they had just released their test performance data and hadn’t even started massive fundraising. Yet, by year-end, they’re on track to complete the resource-intensive prospective study with 10,000 participants?
With a sense of curiosity, I delved into the history of this company, and it turns out they have quite an exceptional background. Harbinger Health originated from Flagship Pioneering, a company that has a rather unique and innovative business model. Before the technical team ventured out of Flagship Pioneering, they spent a whopping three years nurturing and developing their technology within the organization. In its early stages of growth, Harbinger Health also received financial support from Flagship Pioneering.
Now, you might wonder why Flagship Pioneering would generously support a team that was departing with their technology. Well, Flagship Pioneering operates more like an alliance of entrepreneurial scientists than a traditional company. Each year, hundreds of members with keen instincts bring nearly a hundred ideas to the company. Out of these, about 6-8 ideas are confirmed as viable and form the basis for new companies built around their technology platforms. Subsequently, they recruit a board of directors, CEOs, and leadership teams before eventually spinning off and attracting external investors.
Since 2013, this company has successfully spun off 25 companies. One notable example is Moderna, the mRNA company that gained widespread recognition during the COVID-19 pandemic. In January 2015, Moderna secured a record-breaking $450 million in private funding, and on December 6, 2018, it made its debut on NASDAQ with a historic initial public offering (IPO) of $604 million, setting a new record in the biotechnology industry at the time.
Flagship Pioneering’s business acumen is unquestionably impressive. They laid the groundwork in the field of early cancer screening several years ago, and their recent successes are a testament to their strategic vision. Additionally, the growing focus on cancer early screening in the United States by American capital in recent years, including frequent funding allocations by the NIH for early cancer screening projects and Illumina’s determination to acquire Grail even at a significant fine, further confirms this trend. Moreover, companies from China, such as Ransun, FanoGen, Lemunity Health, and Kunyuan Genes, are also striving to expand into the U.S. LDT market.
Why are cancer early screening companies from around the world so determined to enter the U.S. market? Let’s take colorectal cancer as an example. In 2019, the colorectal cancer screening rate in China was only 16.4%, while during the same period, the United States had a screening rate of 60.1%. Additionally, foreign companies often have a price advantage in genetic testing projects. Perhaps a price war can enable them to quickly gain market share? We eagerly await the outcome.
