New Sample-to-Answer PCR System Supports High-Throughput Infectious Disease Testing

Clinical laboratories face mounting demand for rapid, high‑volume molecular testing for infectious diseases, including routine monitoring in immunocompromised patients. Consolidated, sample‑to‑answer workflows with random access and continuous loading can shorten turnaround times and streamline operations. now, new system has launched in Europe that automates polymerase chain reaction testing from sample to result while supporting higher‑throughput needs.

Bruker’s Microbiology & Infection Diagnostics division has introduced MyGenius PRO, a fully automated, sample‑to‑answer (S2A) molecular diagnostics platform based on polymerase chain reaction (PCR) technology at ESCMID Global 2026 in Munich. The European launch targets infectious disease diagnostics and extends the company’s S2A portfolio alongside the medium‑throughput BeGenius system. MyGenius PRO is engineered for higher throughput and automates the full workflow from patient specimen to diagnostic result. The platform is installed at a leading European transplant center supporting routine infectious disease testing.

Image: MyGenius PRO installed at a leading European transplant center supporting routine infectious disease testing (photo courtesy of Bruker)

The system supports continuous loading of samples, consumables, and reagents, and enables random‑access operation to accommodate mixed menus and urgent requests. By consolidating extraction, PCR setup, amplification, and analysis, it is designed to enhance laboratory efficiency and address high‑volume testing requirements. Workflow flexibility associated with BeGenius is maintained, with emphasis on assay and sample‑matrix versatility. These capabilities are intended to support laboratories with scalable molecular operations.

At launch, the MyGenius PRO in vitro diagnostic regulation (IVDR) menu includes assays for Cytomegalovirus (CMV) and Epstein‑Barr virus (EBV) from whole blood, and BK virus (BKV) from urine, supporting diagnostic testing in immunocompromised patients. Additional IVDR assays for Human Immunodeficiency Virus type 1 (HIV‑1), Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human Herpesvirus 6 (HHV‑6), plus more sample matrices, are planned throughout 2026. An accompanying image notes the CMV, EBV, and BKV assays as launched under IVDR. Together, the initial and planned menu broaden viral testing options on the platform.

The platform was developed through collaboration between ELITechGroup, a Bruker company, and Hitachi High‑Tech, combining assay development, automation, and engineering expertise. In Japan, Hitachi High‑Tech will introduce the system under the tradename LABOSPECT GA‑5 with Bruker molecular diagnostic assays for infectious disease testing in accordance with Japanese diagnostic regulations. The launch further expands a portfolio that includes InGenius, BeGenius, a rapidly growing CE‑IVD assay menu, and LiquidArray assays for advanced multiplexing and more affordable syndromic panel testing.

“Timely diagnosis is critical in microbiology and virology. Fully automated sample-to-result solutions improve turnaround time and support faster clinical response and effective infection monitoring, while enabling laboratories to streamline workflows and ensure compliance with IVDR regulations.” said Dr. Pierangelo Clerici, President, AMCLI (Italian Association of Clinical Microbiologists)