On September 23, 2025, South Korea–based biotechnology company Noul received U.S. FDA registration for its cervical cancer diagnostic cartridge system, miLab™ Cartridge CER, and its clearing agent, SafeFix™ CER. The registration officially recognizes miLab CER for legal sale and distribution in the United States.
miLab CER is a part of Noul’s broader miLab system, which aims to make advanced diagnostic testing more accessible through compact, automated, and affordable technology. As the company prepares for phased FDA 510(k) submissions for its disease analysis software, this milestone strengthens Noul’s global position in digital and AI-based cytopathology.
On September 23, 2025, South Korea–based biotechnology firm Noul received U.S. FDA registration for two components of its cervical cancer diagnostic system: the miLab Cartridge CER and its associated clearing agent, SafeFix CER. The registration permits the products to be legally sold and distributed in the United States. The cartridge forms part of Noul’s miLab platform, a compact automated system designed for laboratory diagnostic workflows. Noul has indicated that it is preparing phased FDA 510(k) submissions for its disease-analysis software, which would be required before those modules can be marketed domestically. The latest registration marks a procedural step as the company works to expand the platform’s regulatory clearance and presence in digital and AI-supported cytopathology.
What does Noul do?
Founded in 2015, Noul is a biotechnology company which develops diagnostic platforms integrating biotechnology, microfluidics, and artificial intelligence to enable faster and more accessible biological testing. Its compact, field-deployable systems are designed to extend advanced diagnostic capabilities beyond conventional laboratory settings.
The company is best known for its miLab platform series, which includes specialized variants such as miLab MAL for malaria diagnostics, miLab BCM for blood count and morphology testing, and miLab CER for cervical cytology screening. Each system integrates compact hardware with AI-powered image analysis to automate laboratory workflows within portable, self-contained devices. Together, the miLab platforms enable fast, accurate, and accessible biological testing beyond traditional laboratory settings.
Noul’s innovations have earned both local and international recognition in portable diagnostic technologies. The company was named among NVIDIA GTC’s Top 5 AI Startups in 2021, received the Korean Intellectual Property Office Commissioner Award and the Prime Minister’s Citation Flag Cordon in 2022, and was honored with the 2025 Industrial AI Award by the Ministry of Trade, Industry and Energy, acknowledging its continued contributions to diagnostic technology development.
The patents behind Noul’s miLab CER
The miLab CER is a compact, automated cartridge-based system that incorporates sample preparation, digital imaging, and AI-based cell analysis in one workflow to enhance cervical cancer screening. By streamlining traditional cytology processes, it aims to deliver faster, more consistent diagnostic results and expand access across diverse healthcare settings. This innovation is supported by a portfolio of patents protecting Noul’s core technologies, with key patents highlighted in the following sections.
Contact-type staining patch for simplified biological sample analysis
Conventional staining methods for biological samples rely on manual liquid application, demanding precise reagent control and multiple steps. This results in inconsistent staining, reagent waste, and dependence on skilled operators. Liquid stains also degrade easily, limiting their use in field or low-resource settings. As a result, there is a need for a more stable and user-friendly staining method that delivers accurate, uniform results without complex preparation.
To address this problem, U.S. Patent No. 10,371,610 introduces a contact-type staining patch design that simplifies and standardizes the staining of biological samples such as blood smears. Instead of applying liquid dyes manually, the invention uses a gel-based patch infused with staining, fixing, or buffering reagents that are directly transferred to the specimen upon contact. The gel matrix maintains optimal pH and reagent concentration, ensuring uniform color development without precise mixing or multiple washing steps. This controlled delivery method ensures uniform, reliable staining while reducing dependence on skilled operation.
The patent, titled “Contact-type patch, staining method using the same, and manufacturing method thereof”, was filed on July 9, 2016, and granted on August 6, 2019. The patent lists Noul CEO Chanyang Lim; Dongyoung Lee, Kyunghwan Kim, Youngmin Shin, and Hyunjeong Yang as inventors.
Automated diagnostic system for consistent specimen analysis
Building on this concept, U.S. Patent. No. 11,208,685 extends the innovation by addressing human error and the lack of automation in diagnostic testing. The patent introduces an integrated diagnostic device that automates the entire process, from smearing and staining to imaging and analysis. The system employs a test kit that combines a specimen plate and a patch plate containing the contact-type staining patch, which automatically contacts the sample through controlled mechanical movement.
By unifying specimen preparation and staining within a single automated platform, the device ensures reproducible results while reducing operator dependency. This advancement enables efficient and reliable diagnostics that can be performed outside traditional laboratory environments, bringing standardized testing closer to point-of-care settings.
The patent, titled “Diagnostic method and device performing the same”, was filed on February 27, 2017, and granted on December 28, 2021. The patent lists Chanyang Lim; Dongyoung Lee, Kyunghwan Kim, Youngmin Shin, and Hyunjeong Yang as inventors.
Compact culturing patch for simplified biological and drug testing
Conventional cell and microorganism culturing methods rely on liquid media and controlled lab environments, which require skilled handling and specialized instruments. These constraints make it difficult to perform testing outside laboratories, where maintaining stable and sterile conditions is challenging. This creates a need for a simpler, portable culture system to enable reliable biological and drug-response testing without complex infrastructure.
U.S. Patent No. 11,041,842 introduces a culturing patch that serves as a compact, self-contained system for growing and testing cells or microorganisms. The patch uses a gel-based matrix containing nutrients and reagents that create a stable environment for controlled cell growth and drug-response evaluation. By integrating culturing and testing in one platform, it eliminates the need for liquid media handling and large laboratory instruments. This design reduces contamination risk and simplifies analysis, enabling consistent and reliable biological testing even outside traditional laboratory settings.
The patent, titled “Culturing patch, culturing method, culture test method, culture test device, drug test method, and drug test device”, was filed on February 23, 2017, and granted on June 22, 2021. The patent lists Chanyang Lim, Dongyoung Lee, and Kyunghwan Kim.
Legal representation for all the patents was handled by Jones Day.
Noul: Patenting Activity
Noul’s peak in global patenting activity in 2016 reflects the company’s early efforts to secure protection for its core diagnostic technologies. These filings likely cover the foundational components of its miLab platform, such as microfluidic cartridges, AI-based image analysis, and automated diagnostic workflows. In the subsequent years, Noul’s patent filings declined, indicating a shift from intensive research and development toward product refinement and commercialization.
Noul: Top Jurisdictions
The majority of Noul’s patent filings originate in South Korea, reflecting the company’s strong domestic focus on diagnostic and life science innovation. This is followed by filings in the United States, which highlights the strategic importance of securing IP protection in the world’s largest biotechnology market, accounting for 41.37% global market share.
Noul also extends its patent protection under the PCT system, as well as in Japan and Canada, indicating a proactive approach to expanding its international presence and safeguarding innovation across major global markets.
Noul: Top Law Firms
Noul manages its global patent filings through a diverse network of international law firms. The company’s domestic filings in South Korea are handled by YP Lee, Mock & Partners and IPS Patent Firm. In Europe, Noul is primarily represented by Jan Dantz and Dr. Hubertus Kleine from Loesenbeck Specht Dantz; while in Japan, its filings are managed by Naruto Ikeda and Jun-ichiro Sakamaki from Soei Patent & Law Firm. In the United States, Noul works with Kilpatrick Townsend, Jones Day, and Perkins Coie LLP; while in Canada, the company is represented by Smart & Biggar LP.
Noul: Top Technology Areas
Noul’s global patent filings highlight a strong focus on analytical and diagnostic technologies, which are mostly focused on material analysis (G01N) and laboratory apparatus (B01L) that powers its miLab platform. These are closely followed by filings related to AI-driven image processing (G06T) and automated biological testing (C12Q), reflecting the company’s integration of AI and automation in pathology. Beyond diagnostics, Noul’s filings in biotech and climate-focused technologies points to a broader commitment to sustainable and efficient diagnostic solutions.
Looking ahead
As of 2025, Noul’s miLab platform is available in 28 countries across Asia, Africa, and Europe. The company continues to expand its global footprint through partnerships that promote access to automated diagnostics. In October 2025, Noul entered a supply agreement with Charité University Hospital in Germany to provide miLab systems for clinical use, following a successful evaluation conducted earlier in the year. This agreement marks a significant step in Noul’s expansion within the European healthcare market.
