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.