On July 1st, TCM Biotech announced its collaboration with Instant NanoBiosensors (INB), combining their strengths to address the unmet needs of NGS (Next-Generation Sequencing) testing laboratories. They aim to assist hospitals in setting up "Laboratory Developed Tests (LDTs)" labs and obtaining certifications for NGS-related tests, creating a new business model in the precision medicine industry.

TCM Biotech's General Manager, Ya-Chun Wang, stated that building precision medicine capabilities within hospitals eliminates the need to send samples elsewhere. This not only makes it affordable for patients but also allows hospitals to offer high-quality, stable, long-term services. By providing internationally compliant genetic testing services directly within hospitals, they achieve precise personalized diagnosis and treatment while significantly reducing testing costs. This core advantage benefits patients and creates a win-win situation.

Mr. Ya-Chun Wang pointed out that for NGS to be covered by health insurance, it must be conducted in "regional or higher-level hospitals" or "cancer treatment quality certified hospitals" that are approved by the Ministry of Health and Welfare (MOHW) as LDT labs. However, few hospitals currently meet these criteria. Most hospitals outsource NGS testing to biotech companies with LDT labs and NGS equipment, leading to high testing costs due to imported reagents and equipment.

Furthermore, since basic tests are covered by health insurance with fixed payments, patients often need to pay out-of-pocket for additional tests, which can be a significant financial burden.

The strategic cooperation between TCM and INB will utilize INB's iNA Next-Generation Sequencing Precision Medicine Solution (INVISION Precision Medicine) as a one-stop solution for LDT labs. Leveraging TCM's near-100% coverage of hospitals in Taiwan and their experience in obtaining LDT certifications for NGS testing projects, they aim to promote and implement the NGS precision medical testing system in over 480 hospitals nationwide.

After a doctor recommends tests based on patient needs, a series of procedures, including DNA extraction and purification, can be completed within the hospital. This involves using health insurance-covered cancer gene testing reagents (covering 14 solid tumors and 5 hematologic tumors) for NGS library construction and sequencing, followed by data comparison and automated interpretation analysis through the iNA Reporter bioinformatics reporting system. The entire process is managed internally, replacing the need for extensive manual oversight and expensive third-party testing, thus shortening the wait time for reports and allowing doctors to formulate precise treatment plans promptly.

This setup ensures high-quality standards and fosters long-term relationships with patients, who often require continuous monitoring and more accurate treatment plans.

Instant NanoBiosensors (INB), focused on embedded precision medicine solutions, was selected in 2022 as an Asian enterprise for the UK NHS Global Healthcare Technology Solutions. They have collaborated with the UK Government Innovation Process Center CPI on the Eureka Globalstars transnational CDMO project.

In 2023, INB was invited to participate in the EU Precision Medicine Training Program. This year, they partnered with the Amsterdam University Medical Center (Amsterdam UMC) on a clinical project for Alzheimer’s disease blood testing, supported by the Alzheimer’s Drug Discovery Foundation (ADDF) funded by Bill Gates.

To strengthen international cooperation and expand global influence, INB has established subsidiaries in the Netherlands and demonstration sites in the United States, driving diverse international strategic collaborations to extend their impact in the global healthcare sector.

Mr. Ya-Chun Wang noted that INB’s iNA cancer gene DimerOff reagent and embedded precision medicine solutions have high technical content and competitive market positioning and pricing. Many hospitals already have Illumina NGS sequencing equipment and only need to add or upgrade automated NGS sample preparation, library construction, and the iNA Reporter bioinformatics reporting system. The automation can significantly reduce overall NGS testing costs and improve process quality, with several hospitals currently in the setup phase and more negotiations ongoing, expecting initial benefits in the third quarter.

According to the MOHW, integrating NGS into health insurance coverage is estimated to benefit over 20,000 cancer patients annually, with a budget of approximately 300 million NTD. Including NGS in health insurance drives demand for high-end genetic testing and accelerates the development of the entire industry chain from prevention, diagnosis, treatment, to follow-up, expanding Taiwan’s high-end testing market and marking Taiwan’s entry into the era of personalized precision medicine.

Following its certification by the MOHW for two global first B-hepatitis liver cancer recurrence tracking tests in May, TCM’s partnership with INB further advances their presence in the precision molecular testing lab market. This collaboration will also promote TCM’s "KML liver cancer chimeric DNA testing" and "KML liver cancer free chimeric DNA testing" services, accelerating their expansion in precision medicine and capturing significant high-end testing opportunities, driving future revenue growth.

Resource (mandarin) : 泰宗攜奈捷生技進軍NGS實驗室建置 搶攻高階檢測商機