Restalyst https://restalyst.com/wp Innovating better healthcarfe Mon, 23 Oct 2023 06:42:26 +0000 en-US hourly 1 https://wordpress.org/?v=5.7.10 Restalyst launched new diagnostic assays for Nasopharyngeal Carcinoma and granted Special Access Route (SAR) from Health Sciences Authority, Singapore. https://restalyst.com/wp/blog/2023/04/24/restalyst-launched-new-diagnostic-assays-for-nasopharyngeal-carcinoma-and-granted-special-access-route-sar-from-health-sciences-authority-singapore/ https://restalyst.com/wp/blog/2023/04/24/restalyst-launched-new-diagnostic-assays-for-nasopharyngeal-carcinoma-and-granted-special-access-route-sar-from-health-sciences-authority-singapore/#respond Sun, 23 Apr 2023 18:00:00 +0000 https://restalyst.com/wp/?p=1885 Restalyst launched new diagnostic assays for Nasopharyngeal Carcinoma and granted Special Access Route (SAR) from Health Sciences Authority, Singapore.

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The early detection of Nasopharyngeal carcinoma via diagnostic screening in the laboratory is essential in providing clinicians with the necessary information to deliver the highest level of care to the patients.

A recent supply disruption of an assay used as a gold standard for the early detection of Nasopharyngeal carcinoma in Singapore therefore posed a significant challenge for local Hospital Laboratories which depended on the usage of this assay.

Through collaborations, Restalyst was able to develop 2 new IVD screening assays to fill this gap. The two assays are:
1) EBV VCA-IgA IFA (Epstein-Barr Virus Viral Capsid Antigen – Immunoglobulin A Immunofluorescence Assay)
2) EBV EA-IgA IFA (Epstein-Barr Virus Early Antigen – Immunoglobulin A Immunofluorescence Assay)

This development was made possible in the relatively short time frame of four months with Restalyst’s experience in the design, development and manufacturing of IVD diagnostic tests.

The CEO of Restalyst, Zaccheus Peh, stated that “as a Singapore-based biomedical clinical diagnostic company, Restalyst is committed to providing innovative, reliable and clinically proven diagnostic solutions to the healthcare industry with our R&D and production facilities compliant to ISO13485 standards as well as to the Health Products Act and Health Products (Medical Devices) Regulations in Singapore”.

As a next step, since Restalyst has received approval from the Health Sciences Authority Singapore (via the Special Access Route – GN-27) to market domestically these newly developed EBV VCA and EA-IgA (IFA) assays it now plans for a full product registration submission in the upcoming months in compliance to the Health Products Act 2007 and Health Products (Medical Devices) Regulations Act 2010 with a view to full commercialisation.

]]> https://restalyst.com/wp/blog/2023/04/24/restalyst-launched-new-diagnostic-assays-for-nasopharyngeal-carcinoma-and-granted-special-access-route-sar-from-health-sciences-authority-singapore/feed/ 0 Restalyst is in partnership with All India Institute of Medical Sciences (AIIMS) for a new clinical evaluation in New Delhi https://restalyst.com/wp/blog/2022/06/10/restalyst-is-in-partnership-with-all-india-institute-of-medical-sciences-aiims-for-a-new-clinical-evaluation-in-new-delhi/ https://restalyst.com/wp/blog/2022/06/10/restalyst-is-in-partnership-with-all-india-institute-of-medical-sciences-aiims-for-a-new-clinical-evaluation-in-new-delhi/#respond Fri, 10 Jun 2022 08:25:26 +0000 https://restalyst.com/wp/?p=1720 This project is aimed to study the diagnostic performance of ERBB3 using Restalyst‘s HCC-REAAD™ ERBB3 ELISA together with its diagnostic algorithm for early detection of Hepatocellular Carcinoma in Southern Asia population.

]]> https://restalyst.com/wp/blog/2022/06/10/restalyst-is-in-partnership-with-all-india-institute-of-medical-sciences-aiims-for-a-new-clinical-evaluation-in-new-delhi/feed/ 0 Restalyst had been granted Pandemic Special Access Route (PSAR) for the supply of COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA https://restalyst.com/wp/blog/2022/02/23/restalyst-had-been-granted-pandemic-special-access-route-psar-for-the-supply-of-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/ https://restalyst.com/wp/blog/2022/02/23/restalyst-had-been-granted-pandemic-special-access-route-psar-for-the-supply-of-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/#respond Wed, 23 Feb 2022 02:37:55 +0000 https://restalyst.com/wp/?p=1595 COVID19N-REAAD™ is intended for professional use in detecting COVID-19 patients by detecting patient’s anti-SARS-CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of antibodies is present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

]]> https://restalyst.com/wp/blog/2022/02/23/restalyst-had-been-granted-pandemic-special-access-route-psar-for-the-supply-of-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/feed/ 0 Restalyst received Singapore HSA Provisional Authorization approval for COVID19-REAAD™ Anti-SARS-CoV-2 IgG ELISA https://restalyst.com/wp/blog/2021/06/29/restalyst-received-singapore-hsa-provisional-authorization-approval-for-covid19-reaad-anti-sars-cov-2-igg-elisa/ https://restalyst.com/wp/blog/2021/06/29/restalyst-received-singapore-hsa-provisional-authorization-approval-for-covid19-reaad-anti-sars-cov-2-igg-elisa/#respond Tue, 29 Jun 2021 01:00:40 +0000 https://restalyst.com/wp/?p=1511 This is a product intended for qualitative & quantitative detection of IgG antibodies to SARS-CoV-2 proteins in human serum and plasma.

]]> https://restalyst.com/wp/blog/2021/06/29/restalyst-received-singapore-hsa-provisional-authorization-approval-for-covid19-reaad-anti-sars-cov-2-igg-elisa/feed/ 0 Restalyst signed research collaboration agreement with the National University of Malaysia https://restalyst.com/wp/blog/2020/09/01/restalyst-signed-research-collaboration-agreement-with-the-national-university-of-malaysia/ https://restalyst.com/wp/blog/2020/09/01/restalyst-signed-research-collaboration-agreement-with-the-national-university-of-malaysia/#respond Mon, 31 Aug 2020 16:00:32 +0000 http://restalyst.com/wp/?p=1454 Project to investigate the use of ITIH3 biomarker in screening of individuals with gastric cancer risk

]]> https://restalyst.com/wp/blog/2020/09/01/restalyst-signed-research-collaboration-agreement-with-the-national-university-of-malaysia/feed/ 0 PRESS RELEASE – Singapore’s Restalyst develops highly sensitive COVID-19 antibody test comparable to market leaders https://restalyst.com/wp/blog/2020/08/24/press-release-singapores-restalyst-develops-highly-sensitive-covid-19-antibody-test-comparable-to-market-leaders/ https://restalyst.com/wp/blog/2020/08/24/press-release-singapores-restalyst-develops-highly-sensitive-covid-19-antibody-test-comparable-to-market-leaders/#respond Sun, 23 Aug 2020 16:00:22 +0000 http://restalyst.com/wp/?p=1452 Singapore biomedical firm Restalyst has developed a COVID-19 antibody test, COVID19N-REAAD™, which will be instrumental in establishing disease prevalence in populations and the exposure risk factors associated with infection. Press release was made to countries in APAC, EMEA & LATAM.

]]> https://restalyst.com/wp/blog/2020/08/24/press-release-singapores-restalyst-develops-highly-sensitive-covid-19-antibody-test-comparable-to-market-leaders/feed/ 0 Restalyst received Singapore HSA Provisional Authorization approval for COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA. https://restalyst.com/wp/blog/2020/08/07/restalyst-received-singapore-hsa-provisional-authorization-approval-for-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/ https://restalyst.com/wp/blog/2020/08/07/restalyst-received-singapore-hsa-provisional-authorization-approval-for-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/#respond Thu, 06 Aug 2020 16:00:28 +0000 http://restalyst.com/wp/?p=1450 This is a product intended for qualitative detection of IgG antibodies to SARS-CoV-2 Nucleocapsid Protein in human serum and plasma.

]]> https://restalyst.com/wp/blog/2020/08/07/restalyst-received-singapore-hsa-provisional-authorization-approval-for-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/feed/ 0 Restalyst received the CE mark for RAPIT COVID-19 IgM/IgG Test Kit and COVID19N-REAAD™ Anti-SARS-CoV-2 Nucleocapsid Protein IgG ELISA. https://restalyst.com/wp/blog/2020/07/08/restalyst-received-the-ce-mark-for-rapit-covid-19-igmigg-test-kit-and-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/ https://restalyst.com/wp/blog/2020/07/08/restalyst-received-the-ce-mark-for-rapit-covid-19-igmigg-test-kit-and-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/#respond Tue, 07 Jul 2020 16:00:36 +0000 http://restalyst.com/wp/?p=1448 https://restalyst.com/wp/blog/2020/07/08/restalyst-received-the-ce-mark-for-rapit-covid-19-igmigg-test-kit-and-covid19n-reaad-anti-sars-cov-2-nucleocapsid-protein-igg-elisa/feed/ 0 Restalyst received Singapore HSA Provisional Authorization approval for RAPIT COVID-19 IgM/IgG Test Kit https://restalyst.com/wp/blog/2020/07/01/restalyst-received-singapore-hsa-provisional-authorization-approval-for-rapit-covid-19-igmigg-test-kit/ https://restalyst.com/wp/blog/2020/07/01/restalyst-received-singapore-hsa-provisional-authorization-approval-for-rapit-covid-19-igmigg-test-kit/#respond Tue, 30 Jun 2020 16:00:40 +0000 http://restalyst.com/wp/?p=1446 This a lateral flow chromatography immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human plasma, serum, finger pricked whole blood or whole blood.

]]> https://restalyst.com/wp/blog/2020/07/01/restalyst-received-singapore-hsa-provisional-authorization-approval-for-rapit-covid-19-igmigg-test-kit/feed/ 0 Restalyst @ MEDICA 2019 https://restalyst.com/wp/blog/2019/11/22/restalyst-medica-2019/ https://restalyst.com/wp/blog/2019/11/22/restalyst-medica-2019/#respond Thu, 21 Nov 2019 16:00:17 +0000 http://restalyst.com/wp/?p=1444 18-21 Nov 2019. Restalyst participated in Medica 2019 under the Singapore Pavilion to promote her innovative cancer tests to the world.

]]> https://restalyst.com/wp/blog/2019/11/22/restalyst-medica-2019/feed/ 0 Restalyst offered HCC-REAAD™ ERBB3 ELISA for gastric cancer surveillance study in Poland https://restalyst.com/wp/blog/2019/07/11/restalyst-offered-hcc-reaad-erbb3-elisa-for-gastric-cancer-surveillance-study-in-poland/ https://restalyst.com/wp/blog/2019/07/11/restalyst-offered-hcc-reaad-erbb3-elisa-for-gastric-cancer-surveillance-study-in-poland/#respond Wed, 10 Jul 2019 16:00:48 +0000 http://restalyst.com/wp/?p=1441 https://restalyst.com/wp/blog/2019/07/11/restalyst-offered-hcc-reaad-erbb3-elisa-for-gastric-cancer-surveillance-study-in-poland/feed/ 0 Restalyst @ MEDICA 2018 https://restalyst.com/wp/blog/2018/10/10/restalyst-medica-2018/ https://restalyst.com/wp/blog/2018/10/10/restalyst-medica-2018/#respond Wed, 10 Oct 2018 03:26:32 +0000 http://restalyst.com/wp/?p=1180
12 - 15 Nov 2018

As part of its commitment to continuous innovation, Restalyst will be participating in Medica 2018.
Visit us at Singapore Pavilion Hall 3 Booth G74.

]]> https://restalyst.com/wp/blog/2018/10/10/restalyst-medica-2018/feed/ 0 Restalyst received Singapore HSA approval for an improved version of its gastric cancer screening kit – GC-REAAD™ https://restalyst.com/wp/blog/2018/08/20/restalyst-received-singapore-hsa-approval-for-an-improved-version-of-its-gastric-cancer-screening-kit-gc-reaad/ https://restalyst.com/wp/blog/2018/08/20/restalyst-received-singapore-hsa-approval-for-an-improved-version-of-its-gastric-cancer-screening-kit-gc-reaad/#respond Mon, 20 Aug 2018 03:22:57 +0000 http://restalyst.com/wp/?p=1178 GC-REAAD™, an in-vitro diagnostic medical device for the early detection of gastric cancer, was developed based on competitive ELISA platform in 2015. It was recently improved to a sandwich ELISA platform and approved by Singapore HSA.

]]> https://restalyst.com/wp/blog/2018/08/20/restalyst-received-singapore-hsa-approval-for-an-improved-version-of-its-gastric-cancer-screening-kit-gc-reaad/feed/ 0 Singapore’s Restalyst develops new method to improve liver cancer diagnosis https://restalyst.com/wp/blog/2017/11/14/singapores-restalyst-develops-new-method-to-improve-liver-cancer-diagnosis/ https://restalyst.com/wp/blog/2017/11/14/singapores-restalyst-develops-new-method-to-improve-liver-cancer-diagnosis/#respond Tue, 14 Nov 2017 04:19:14 +0000 http://restalyst.com/wp/?p=1016 Restalyst press release 2017

]]> https://restalyst.com/wp/blog/2017/11/14/singapores-restalyst-develops-new-method-to-improve-liver-cancer-diagnosis/feed/ 0 Restalyst launched effective liver cancer diagnostic kit at MEDICA 2016 https://restalyst.com/wp/blog/2016/11/11/launch-of-hcc-reaad-diagnostic-kit/ https://restalyst.com/wp/blog/2016/11/11/launch-of-hcc-reaad-diagnostic-kit/#respond Fri, 11 Nov 2016 08:23:12 +0000 http://reste-group.com/?p=162 This ELISA-based diagnostic kit (known as HCC REAAD) was developed by Restalyst based on patented technology by the Chang Gung Memorial Hospital (Taiwan).

]]> https://restalyst.com/wp/blog/2016/11/11/launch-of-hcc-reaad-diagnostic-kit/feed/ 0 Restalyst launched new, more accurate gastric cancer screening kit at MEDICA 2015 https://restalyst.com/wp/blog/2015/11/11/gc-reaad-launch/ https://restalyst.com/wp/blog/2015/11/11/gc-reaad-launch/#comments Tue, 10 Nov 2015 20:06:24 +0000 http://reste-group.com/?p=1 This ELISA-based diagnostic kit (known as GC-REAAD) was developed by Restalyst together with the National University of Singapore.

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