Direct RT-PCR COVID-19 Test Kit RESOLUTE 2.0 Available In The European Union After Receiving CE Mark

Singapore (GLOBE NEWSWIRE) -

• Compatible With A Variety Of Testing Methods Including Deep-Throat Saliva, Oropharyngeal/Middle Turbinate And Nasopharyngeal Test Swabs
• One Of The Few Direct RT-PCR Tests To Have Received Ce Mark, RESOLUTE 2.0 Provides Highly Accurate Ultra-Fast Results In Half The Time Taken By Conventional PCR Tests
• Can Be Used At Various Entry Points As The EU Gradually Reopens Its Borders

AMT Pte Ltd, a Singapore-based medtech manufacturing unit and a wholly-owned subsidiary of Advanced MedTech Holdings, has announced today that its RESOLUTE 2.0 direct RT-PCR test kit has received the CE mark approval. The CE Mark approval means the test kit has met European Union’s safety, health and environmental protection requirements. The RESOLUTE 2.0 kit is now available for sale in the European Union.

RESOLUTE 2.0 does not need to extract viral RNA from patient test samples, minimizing potential human errors. RESOLUTE 2.0 provides highly accurate ultra-fast results in about 60 minutes, while conventional PCR tests usually take 2.5 hours or longer. RESOLUTE 2.0 can also be paired with the high throughput automation platform, RAVE, to process an industry-topping 4 times more throughput than the usual RT-PCR test volume in a day

The RESOLUTE 2.0 kit will be administered at the COVID-19 testing lab that will open in Changi Airport.

Abel Ang, Group Chief Executive of Advanced MedTech, said “Highly accurate and ultrafast PCR testing for COVID-19 is not going away, even as countries across the EU are ramping up their vaccination drives. To safely reopen borders for leisure and business travel, testing will be critical to ensure the safety and wellbeing of EU citizens, and travelers. We are pleased to receive the CE mark for the RESOLUTE 2.0 kit as we can now contribute to fast, accurate and reliable testing in the EU.”

The RESOLUTE 2.0 kit was jointly developed by Singapore’s Agency for Science, Technology and Research (A*STAR) and DSO National Laboratories, while the RAVE was developed by A*STAR. AMT manufactures and distributes the RESOLUTE 2.0 test kits and distributes the RAVE automated robotics laboratory system.

About AMT
AMT Pte Ltd, a wholly owned subsidiary of Advanced MedTech Holdings, was established in 1990 and headquartered in Singapore. AMT provides end-to-end medical device development and manufacturing services globally. Besides its core capability in Metal and Ceramic Injection Molding, AMT Pte Ltd also offers total solutions from ideation to manufacturing of medical devices using its laboratory and BSL level 2+ facility for IVD test kits manufacturing and cleanroom assembly spread across Singapore, China and Malaysia. Armed with ISO 13485, ISO 11135 & ISO 9001 certifications, AMT has more than 30 years’ experience in delivering high quality products which consistently meets customers’ stringent manufacturing requirements. For more information, please visit www.amt-mat.com.

About Advanced MedTech Holdings
Advanced MedTech Holdings is a global medical technology leader with a core focus in urology devices and services. Headquartered in Singapore, with operations in US, Germany, Spain, France, Italy, China, Malaysia and Japan, the Company serves millions of patients and physicians in 100 countries worldwide. Advanced MedTech Holdings makes strategic investments in disruptive medical technology companies, strengthening its portfolio of healthcare solutions for customers around the world. Advanced MedTech Holdings is a wholly-owned subsidiary of Temasek. For more information on Advanced MedTech Holdings, please visit www.advanced-medtech.com.

About RESOLUTE 2.0
RESOLUTE 2.0, an industry-first SARS-CoV-2 direct multiplex Reverse-Transcription Polymerase-Chain-Reaction (RT-PCR) assay kit co-developed by Singapore’s Agency for Science Technology and Research (A*STAR) and DSO National Laboratories (DSO), has been made available for clinical use by Advanced MedTech Holdings (AMTH), a global medical technology leader. RESOLUTE 2.0 eliminates the need for extraction of viral RNA from patient test samples, thus minimising potential human errors and halving the test delivery time when compared to other approved RT-PCR kits which are considered the gold standard in SARS-CoV-2 detection. A multiplex RT-PCR, RESOLUTE 2.0 also allows for simultaneous detection of multiple SARS-CoV-2 targets and human control target in one single reaction. For more information on the RESOLUTE 2.0 test, please visit www.advancedcovidtest.com

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