Marketing authorisation in Singapore: Allplex SARS-COV2 Assay

2020-06-30T18:02:04+08:00 June 30th, 2020|News & Events|
OSCAR system

Seegene Inc. has obtained provisional authorisation from the Health Sciences Authority (HSA) in Singapore for its Allplex™ SARS-CoV-2 Assay thanks to its ongoing partnership with Andaman Medical Pte Ltd, a regulatory affairs and market access consultancy specializing in South Asian markets for medical device and in-vitro diagnostics manufacturers.

In response to the COVID-19 outbreak Andaman Medical decided to offer its registration services free of charge for those products helping fight the pandemic that could be registered via Special Access Routes for both existing and new clients.

As an existing client since 2017, Seegene took up Andaman Medical’s COVID-19 special access route offer and is now happy to announce that it has secured Provisional Authorisation for Seegene’s Allplex™ SARS-CoV-2 Assay from the HSA in Singapore.

The Allplex™ SARS-CoV-2 Assay detects target genes specific to COVID-19 within a single tube and offers results in a short turnaround time of 1 hour and 50 minutes. This means patients can get accurate results and ultimately access to the appropriate treatment quickly.

Notes:

Background to the Seegene / Andaman Medical partnership.

Seegene first appointed Andaman Medical back in 2017 to register an initial product range of IVD test kits in Singapore and act as its local authorised representative in the market.

Relying on the expertise of Andaman Medical’s in-house Regulatory Affairs Specialist for Singapore, Mrs Jhelum Bandyopadhyay, Seegene recently expanded its portfolio of products for registration in Singapore to include other types of assays of varying risk class and now also includes its Allplex™ SARS-CoV-2 Assay.

About Seegene’s Allplex™ SARS-CoV-2 Assay

The Allplex™ SARS-CoV-2 Assay is an in vitro diagnostic medical device designed for qualitative detection of SARS-CoV-2 with real-time reverse transcription PCR from nasopharyngeal aspirate, nasopharyngeal swab, bronchoalveolar lavage, oropharyngeal (throat) swab, and sputum.

About Seegene Inc.

Seegene (KQ : 096530) is a global pioneer in symptom-based in vitro molecular diagnostics focusing on advancing science to develop multiplex molecular technologies and to manufacture multiplex in vitro diagnostic devices and reagents. Seegene’s core enabling power is the passion for wide spreading of multiplex molecular diagnostics to improve the quality of life and health of people. Using its innovative proprietary technologies, Seegene has been making considerable contributions to giving the most economic and clinic-friendly molecular diagnostic solutions for infectious diseases, genetics, pharmacogenetics, and oncology. For more information, please visit www.seegene.com.

About Andaman Medical Pte Ltd, Singapore.

Andaman Medical is regulatory affairs and market access consultancy specializing in South Asian markets for medical device and in-vitro diagnostics manufacturers who are looking to bring their products to market to ultimately improve the health and quality of life of millions of people.

Unlike other regulatory agencies who outsource to external consultants, Andaman Medical is unique in that it employs fulltime in-house Regulatory Affairs Specialists in its seven local country offices, this means they are well placed to build relationships with the national regulatory authorities.

Since being founded in 2013 by Mourad Kholti, Andaman Medical has registered and acts a local authorised representative for over a thousand different medical devices of all classes. And also offers importation and master distribution services in select countries helping clients literally supply their product to the end user.

With corporate social responsibility part of its DNA, and in response to the worldwide COVID-19 pandemic, Andaman Medical decided to offer its registration services free of charge for those products helping fight the pandemic that could be registered via Special Access Routes to both new and existing clients.

If you have any queries regarding our registration services for medical device registration and representation including Special Access Routes in Singapore, please contact us at contact@andamanmed.com.