Following the holiday celebrations, Rocgene announces an important milestone: the Atlas 120 Fully Automated Nucleic Acid Purification and Real-Time Fluorescence PCR Analysis System has obtained China's Class III medical device registration. National Medical Device Registration No.: 20263222132.

Class III registration is an important step in bringing Atlas 120 from a functioning system into regulated clinical use.

From development and submission for testing to completion of the Class III medical device registration review, this milestone reflects Rocgene's commitment to independent development and manufacturing. It also enables a domestically developed, fully automated nucleic acid analysis system designed for surveillance and early warning at centres for disease control and prevention to enter a broader market with the required regulatory status.

The registration demonstrates that Atlas 120 has undergone systematic regulatory evaluation of safety, effectiveness, quality control and clinical performance. It provides a documented basis for confidence in the equipment's performance and quality.

What Is Atlas 120?

Developed around the challenges faced by centres for disease control and prevention in infectious-disease surveillance, the Rocgene Atlas 120 integrates nucleic acid extraction, liquid handling and reaction setup, amplification, and detection into a fully automated sample-in, result-out workflow. Its advantages include full-process automation, high-throughput multiplex testing, on-demand sample processing, direct loading of original sample tubes and an open, compatible platform. It supports both routine surveillance and emergency testing during public-health events.

• Open platform: Compatible with a range of reagents and flexible preconfigured test menus, supporting respiratory and gastrointestinal syndrome screening, bacterial and fungal resistance analysis, and vector-borne pathogen testing.

• Extensive multiplexing: Four amplification tubes per sample, combined with six fluorescence channels, support detection across 12 × 24 target genes. The system covers a broad range of common and emerging pathogens to improve syndromic screening efficiency.

• On-demand testing: Twelve sample channels with independent temperature control and a 12 × 4 amplification layout support individual or multiple samples as they arrive. Multiple test menus can run together, while continuous sample loading accommodates both routine batches and urgent, irregular samples for multi-trigger disease surveillance.

• Integrated design: Individually prepacked extraction reagents are ready to use. Error-prevention features simplify operation and support staffing conditions in primary-level facilities.

• Direct original-tube loading: Barcode-based loading of original sample tubes supports a complete sample-in, result-out workflow. One-step operation reduces labour requirements.

• Rapid response: During public-health emergencies, a single sample can produce a report within one hour, with subsequent reports available at intervals of no more than 10 minutes.

• Multiple contamination safeguards: Seal-piercing aspiration, anti-drip features, splash barriers, directed airflow, negative-pressure control, HEPA filtration and ultraviolet disinfection help reduce biological contamination risk.

• Intelligent management: A touchscreen interface and voice prompts guide the workflow. The system supports LIS/HIS data transfer, multi-level user accounts, automatic data storage, customised experimental reports and one-step report export.

Why It Matters

Registration does more than establish regulatory status: it connects the product's capabilities with practical testing needs.

Centres for disease control and prevention across China are upgrading infectious-disease surveillance. Increased demand for syndromic multipathogen monitoring, wastewater pathogen surveillance and vector-borne pathogen monitoring places greater emphasis on automation, multiplexing and rapid response. Atlas 120's integrated sample-in, result-out design, extensive multiplexing and on-demand operation provide an automated, intelligent approach to syndromic surveillance and multipathogen nucleic acid screening.

Value for Clinical Diagnosis and Public Health

Atlas 120 delivers value in four areas:

01 Reduce the Staffing Burden

A fully automated workflow, direct original-tube loading and sample-in, result-out operation reduce dependence on specialist laboratory personnel while improving testing throughput and overall efficiency.

02 Respond Flexibly to Surveillance Needs

On-demand processing of individual or multiple samples, an open reagent platform and simultaneous operation of multiple test menus support continuous loading for routine batches and emergency testing across multiple surveillance triggers.

03 Improve Response Speed

A 12 × 4 amplification layout supports high-throughput testing, while a single-sample report within one hour enables a rapid response to clustered outbreaks and testing for pathogens in unexplained infections.

04 Support Reliable Results

Six layers of contamination prevention, combined with sensitive testing, reduce cross-contamination risk and improve testing accuracy.

Driven by Innovation

Class III registration marks a new stage for Atlas 120. Rocgene will continue to develop around clinical needs, using its core technologies to deliver innovative, fully automated, multipathogen solutions that can be implemented in practice. These capabilities support clinical diagnostics and the development of public-health surveillance and early-warning systems.

Innovation Developed in China, Protecting Health and Lives