A Historic Breakthrough! Hymon® Pan-Cancer Screening Test Kit Secures FDA’s Second Global Pan-Cancer Early Screening “Breakthrough Device Designation”

Global cancer early screening has reached a milestone—with the city “Suzhou, China” now twice inscribed on the official US FDA website by the same Chinese company. On June 10, 2026, Suzhou-based HymonBio Co., Ltd. announced their independently-developed “Hymon® Pan-Cancer Screening Test Kit” has officially received the US FDA Breakthrough Device Designation. This marks not only the second such designation awarded by the FDA globally in the pan-cancer early screening sector but also the first time a Chinese product has achieved this prestigious honor.

Previously, the only product worldwide to receive this designation was Galleri, developed by the U.S. company Grail (approved in 2019). In 2021, sequencing giant Illumina acquired Grail for a staggering $8 billion. Seven years later, this honor—often hailed as the “top-tier pass” for pan-cancer early screening—has finally come to China.

One of Only Two Worldwide: How Valuable Is This “Pass”?

The FDA’s “Breakthrough Device Designation” is not a standard regulatory approval; rather, it is reserved for innovative technologies with the potential to revolutionize the diagnosis or treatment of life-threatening or irreversibly debilitating conditions. As of the end of 2025, the FDA had granted only about 1,200 such designations across the entire medical device landscape. Notably, within the pan-cancer early screening sector—which features exceptionally high technological barriers, lengthy R&D cycles, and extremely rigorous clinical validation—Grail had previously been the sole recipient.

HymonBio Co., Ltd. has now secured the world’s second such designation, marking a pivotal shift for China in the pan-cancer early screening field—a transition from “technology follower” to “original innovator.” More importantly, this achievement demonstrates the “Hymon® Pan-Cancer Screening Test Kit” has reached a world-class level in terms of technological innovation, clinical value, and scientific rigor, thereby paving a fast track for its entry into the U.S. market.

Technological Disruption: Defeating Expensive NGS with “PCR + AI”

Grail’s Galleri uses NGS (next-generation sequencing) technology. While NGS is cutting-edge, it requires expensive equipment, complex procedures, and costly reagents, with per-test prices remaining prohibitively high, severely hindering widespread adoption.

HymonBio has forged an entirely new technological path. The “Hymon® Pan-Cancer Screening Test Kit” deeply integrates artificial intelligence (AI) with classic PCR technology (polymerase chain reaction—a mature, Nobel Prize-winning technique). Based on methylation-specific PCR and proprietary AI algorithms, the product performs a multi-dimensional assessment of abnormal methylation levels in the test data. By simply drawing a single 5ml tube of venous blood, it enables precise early screening for 28 types of highly prevalent and lethal cancers using standard PCR equipment found in the clinical laboratories of ordinary hospitals.

From “Exorbitant Screening” to “Affordable for All”

Compared to NGS-based methods that rely on expensive sequencers and imported reagents, the AI + PCR technological route adopted by the “Hymon® Pan-Cancer Screening Test Kit” offers a cost advantage of orders of magnitude. Public data indicates that the Galleri test from the US-based company Grail costs over $1,000 per unit; in contrast, the “Hymon® Pan-Cancer Screening Test Kit” achieves a significant reduction in testing costs while maintaining high performance—pricing it well below mainstream international counterparts—thereby truly delivering a solution that is both accurate and affordable.

This marks a shift for pan-cancer early screening: moving from a “luxury affordable only to the few” to an “an accessible tool for everyone.” Dr. Tammy Tan, Chairman of HymonBio, stated: “Our goal is not merely to ensure accuracy in early cancer screening, but to make it affordable for everyone. Only by effectively translating technology into accessible medical services can we fundamentally alter the predicament of late-stage cancer detection and the resulting treatment challenges.”

A New Bellwether for Global Capital: Chinese Innovation Undergoing Revaluation

In 2019, after Grail secured the first “Breakthrough Device” designation for a pan-cancer early screening test, it sparked a frenzy of investor enthusiasm, ultimately leading to its $8 billion acquisition by Illumina in 2021. This classic case of “valuation driven by regulatory designation” remains a benchmark in the global biotechnology sector. Now, as one of only two pan-cancer early screening products worldwide with FDA breakthrough designation, the “Hymon® Pan-Cancer Screening Test Kit” holds immense commercial value and strategic significance.

Even more noteworthy is that global capital’s valuation of the pan-cancer early screening track has long since moved beyond “waiting for formal FDA approval.” Historic deals—such as Abbott’s $21 billion acquisition of Exact Sciences—demonstrate that industry giants view the strategic value of this sector as the ultimate certainty. HymonBio has not only secured a foothold in this arena but also holds the “premium pass” issued by the FDA; this development promises to serve as a key indicator prompting global capital to re-examine and re-evaluate the value of Chinese pharmaceutical innovation.

Nine Years of Sharpening a Sword: A Chinese Solution Illuminating the Global Fight Against Cancer

From receiving EU CE certification in 2022 to passing the rigorous FDA review and securing Breakthrough Device Designation in 2026, HymonBio has devoted nine years to intensive R&D, ultimately achieving a pioneering “zero-to-one” breakthrough for China in the field of pan-cancer early screening. The “Hymon® Pan-Cancer Screening Test Kit” not only offers a beacon of hope for early cancer detection to hundreds of millions of high-risk individuals worldwide but also—through its homegrown technology and a strategy of accessible, precision screening—provides the global fight against cancer with a highly cost-effective “Chinese solution.”

(Dr. Tan Miao, Chairman of HymonBio Co., Ltd., giving a lecture at the University of Leeds, UK)

Dr. Tammy Tan, Chairman of HymonBio, stated that the company will continue to deepen its focus on early cancer screening and precision medicine. By accelerating the clinical translation of more “zero-to-one” breakthroughs for the benefit of the public, HymonBio aims to contribute Chinese technological strength to the “Healthy China” initiative and the global cause of public health.