HDT Is Stepping into the Spotlight: Standing at the End of 2025, Reinterpreting the Harshness and Fairness of the NGS Upper Stream — An Interview with Dr. Cai Wanshi, CEO of iGeneTech
Looking back at 2025, LDT, or HDT as it is called in the industry, remains a hot topic of discussion. Although the progress of LDT has not been entirely satisfactory, it is still regarded as another viable path for compliant commercialization alongside IVD.
In July, the second batch of LDT pilot programs was launched. On the whole, it still followed the rules of the first batch of LDT pilots, adding 19 new pilot hospitals. Together with the 11 hospitals from the first batch, the current LDT pilot institutions include 29 hospitals plus the newly established National Medical Center. No independent enterprises have been included in the pilot scope so far, which is why insiders refer to it as HDT.
In October, the Beijing Municipal Health Commission and the Beijing Municipal Drug Administration jointly issued the Notice on Regulating the Administration of Clinical High-Throughput Sequencing Laboratories and Related Medical Device Products in Medical Institutions (Jingwei Yi〔2025〕No. 89).
The document included the following statement:
From the date of issuance of this Notice, when medical institutions (including third-party testing institutions) conduct clinical high-throughput sequencing—for purposes such as disease prevention, diagnosis, treatment monitoring, health status assessment, and prediction of hereditary diseases (excluding scientific research)—they shall file a record of the relevant testing items with health administrative departments. Additionally, the relevant medical device products used must be registered or filed with drug regulatory authorities before they can be applied. Medical institutions that fail to meet the above requirements must immediately cease conducting relevant sequencing work.
End of 2025, Reinterpreting the Harshness and Fairness of the NGS Upper Stream — An Interview with Dr. Cai Wanshi, CEO of iGeneTech
This seems to have placed a constraint on many unapproved/recorded projects, but it has also reignited a new round of expectations and discussions about LDT. Against this backdrop, we invited Dr. Cai Wanshi, CEO of iGeneTech, to discuss the development of LDT in 2025, potential regulatory considerations, and the future transformation of LDT.
Q: Dr. Cai, discussions about LDT remained intense in 2025. People hold divergent attitudes toward the relevant policies. The optimistic view is that LDT has been liberalized again, and it seems that regulators are also guiding this trend forward. The pessimistic view is that LDT has failed to become a strong complement to IVD as expected, and the stringency of regulatory rules is getting infinitely close to that of IVD. Especially after the issuance of Notice on Regulating the Administration of Clinical High-Throughput Sequencing Laboratories and Related Medical Device Products in Medical Institutions (Jingwei Yi〔2025〕No. 89), unapproved/recorded projects have been "prohibited", making LDT a possible lifeline again. What is your take on the changes in LDT-related policies in 2025?
Dr. Cai Wanshi: In my opinion, what truly changed by the end of 2025 was not LDT, but HDT. LDT has actually been discussed for many years — both in the industry and clinical practice, all stakeholders have been groping their way forward between practical needs and regulatory norms. But this time is different. You can see that from policy wording to practical actions, there has been a clear shift toward the standardized advancement of HDT: the filing process for testing items in oncology, genetics, pathogens and other fields has been gradually clarified, and supporting standardized training programs for clinical high-throughput sequencing laboratories have been launched simultaneously. These signals combined indicate one thing: HDT is no longer just a topic of discussion; instead, systematic preparations are underway for its implementation.
Against this backdrop, I would like to pour cold water on this optimism — after HDT is fully integrated into the clinical operation system, the industry will not become easier, but more brutal. At the same time, however, I believe this is the fairest opportunity in the past decade for companies that truly possess core underlying capabilities.
Q: Why do you describe it as "brutal"? Many enterprises view this as an obvious positive development.
Dr. Cai Wanshi: Because over the past decade and more, there has been a neglected issue in China's NGS industry — a considerable portion of capabilities have been operating under vague institutional boundaries, rather than being repeatedly validated within a rigorous methodological accountability system. Now, as HDT-related norms are gradually clarified, the focus of regulation is shifting: instead of only focusing on product registration certificates, regulators are beginning to systematically oversee laboratories, methodologies, and whether enterprises have the capability to take long-term responsibility for testing results. What does this mean? HDT does not mean "free rein"; instead, the accountability for testing is clearly shifted forward, and it is a continuous, traceable responsibility.
Under such a system, problems with unstable probe design, capture systems with high batch-to-batch variability, and protocols that only work "in the short run" but cannot withstand long-term operation will be continuously amplified until these products are eliminated.
Q: Then why do you say this is the "fairest era"?
Dr. Cai Wanshi: Because this time, competition has finally returned to core underlying capabilities. In the HDT scenario, what hospitals and laboratories truly care about are not fancy marketing pitches, but very specific and practical questions:
Can this panel run continuously for three years in a real clinical setting?
Can data remain comparable after replacing probes from different batches?
Can the methodology stand up to random inspections, retrospective reviews, and quality control audits?
These questions cannot be solved by any marketing tactics. Only long-term stable wet lab capabilities, clear and interpretable design logic, and data consistency that is highly compatible with downstream systems can truly hold up in the HDT system. Only long-term stable wet lab capabilities, clear and interpretable design logic, and a continuously accumulated data foundation can provide answers to these questions.
Q: As HDT gradually moves toward standardization, some upstream enterprises have begun to directly target hospitals or laboratories. Will iGeneTech's positioning change in the future?
Dr. Cai Wanshi: Our internal discussions on this issue have been very thorough and prudent. iGeneTech has always positioned itself behind IVD manufacturers, not in front of them. We do not intend to, nor will we, form any form of competitive relationship with our existing IVD customers. From the very beginning, our positioning has been clear: we are an upstream supplier of NGS panels and their supporting automated solutions, not a definer of testing items, let alone a provider of clinical services.
Behind this positioning is a very practical consideration — if upstream manufacturers directly target hospitals, existing IVD customers will inevitably have unnecessary concerns, and such concerns will not benefit the entire industrial chain.
Q: You have mentioned the "upper stream" many times, especially probes and capture technologies. Why have these become the key?
Dr. Cai Wanshi: Because in the HDT system, probes are no longer just "consumables", but part of the methodology. This is a change that many people have not yet truly realized. In the HDT scenario:
The panel itself is part of the laboratory's capability to define testing items;
The probe design logic needs to be incorporated into SOPs and performance verification systems;
Capture performance is subject to continuous quality monitoring and methodological review.
Once entering this system, what upstream manufacturers deliver is no longer just a box of reagents, but a commitment to long-term stability. This is pressure for companies that only know how to "sell products", but an opportunity for companies that truly understand the essence of design, synthesis and capture technologies.
Of course, we are also very clear that even in the HDT system, panel reliability and automation stability are only part of many links. Strictly speaking, HDT is a typical multi-link system engineering project:
At the wet lab level, panels and capture technologies are just one link, which also includes upstream sample extraction and library construction systems, as well as downstream sequencing platform adaptation;
At the system level, it also involves LIMS-HIS integration, dry lab analysis pipelines, and the ultimate responsibility for clinical interpretation and reporting.
What iGeneTech focuses on is the part of the wet lab system that requires the most long-term stability and repeatability. We do not aim to "cover everything", but to make this segment sufficiently reliable, transparent and verifiable.
Q: Amid this round of changes, what forward-looking layout has iGeneTech made?
Dr. Cai Wanshi: Over the past few years, we have mainly focused on three things:
l Refine data indicators to eliminate ambiguity. Metrics such as Fold80, uniformity and coverage CV are not just display indicators, but data that must stand up to review for every batch.
l Treat design logic as core assets. Why retain this region? Why abandon that region? The design logic varies in different clinical scenarios such as oncology, genetics, MRD and cfDNA. We require our team to clearly explain the "why" behind every design decision.
l Force ourselves to adapt to real clinical rhythms. Sample input is low, sample types are complex, and demands change rapidly. If the system cannot run stably under these conditions, it is only "usable for research", not "sustainable for clinical practice".
Q: Some people argue that "existing indicators are sufficient". What is your opinion on this?
Dr. Cai Wanshi: This is a very dangerous judgment. In the research phase, "sufficiency" may hold true; but in the HDT operation system, "sufficiency" often means problems will arise sooner or later. Because clinical practice is not a one-time experiment, but:
Long-term operation;
Multi-person operation;
Superposition of multiple batches;
Data comparability over multiple years.
If you think "being slightly off is acceptable" today, all problems will surface together in a few years. Therefore, the judgment for the next phase is very clear: technical indicators and methodological stability must be refined to the point of being "irreplaceable", not just "good enough".
Conclusion
In retrospect, 2025 may not be remembered as the year when HDT was fully rolled out, but it will definitely be remembered as the year when the industry began to pay a real price for HDT. From training to filing, from methodological review to the shift
of accountability forward, changes did not happen overnight, but rather step by step to close the gaps of ambiguity. After 2026, there may still be differences in the pace of HDT's full implementation; but one thing is irreversible: testing is no longer just about "whether it can be done", but about "whether there is the capability to take long-term responsibility". When the upstream shifts from "delivering reagents" to "delivering part of the methodology", the industry's real watershed has just emerged. This time, time is on the side of long-termism.
CN
