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1Drop inc., through the efforts of its exclusive Canadian distributor Luminarie Canada, receives approval of its 1copy™ COVID-19 qPCR Multi Kit under the Minister of Health’s Interim Order

 

  

March 31, 2020 19:17 ET  | Source:  Luminarie Canada Inc.

 

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1copy™ COVID-19 qPCR Multi Kit has a short measurement time of less than 2 hours.

Highly Sensitive Assay: Limit of detection of 200 genome copies per mL,
which is equivalent to 4 genome copies per PCR reaction.

MONTREAL, March 31, 2020 (GLOBE NEWSWIRE) -- Luminarie Canada Inc. (“Luminarie”) and its development partner 1drop Inc. (“1drop”) announced today that Health Canada, pursuant to section 5 of the Interim order respecting the importation and sale of medical devices for use in relation to COVID-19, made by the Minister of Health on March 18, 2020, has issued an authorization for importation and sale of 1drop’s novel RT-qPCR “1copy™ COVID-19 qPCR Multi Kit” (“PCR kit”). Luminarie is the exclusive distributor of this PCR kit in Canada.

Yanick Thibeault, President of Luminarie Canada, commented, “We hope the availability of this new PCR kit from 1drop, an emerging leader in point-of-care testing and rapid PCR assays, will help support the public health community in its fight against COVID-19 by allowing the introduction of another rapid and highly sensitive PCR test to ensure an uninterrupted supply in Canada.”

The 1copy™ COVID-19 qPCR Multi Kit allows qualitative detection of SARS-CoV-2 by amplification of two target genes (E gene and RdRp gene) of the virus causing COVID-19 with real-time qPCR (including reverse-transcription reaction) via RNA extracted from clinical specimens (nasopharyngeal swabs or oropharyngeal swabs) of suspected respiratory infectious disease patients. RdRp is the SARS-CoV-2 specific detection target, and the E gene is detection target specific to the beta coronavirus.

In addition to its extremely high sensitivity (limit of detection of 200 copies per mL), the PCR kit has a short measurement time that allows to obtain results in less than 2 hours.

Hospitals and reference laboratories can run this new assay on a wide range of Real-Time PCR Instruments which are widely available across Canada and around the world.

The 1copy™ COVID-19 qPCR Multi Kit is presently approved and/or commercialized in several countries, including Germany, South Korea, Sri Lanka, Luxemburg, Paraguay, Georgia, Bulgaria and Canada. It has been submitted for approval in several countries, including the United States.

About 1drop Inc.

1drop was incorporated in 2017 following a technology spin-off from Samsung Electronics’ C-Lab program. Samsung Electronics’ C-Lab, located in South Korea is an internal incubation program that first started in 2012 to help inspire a more creative company culture.

1drop already had more than five products approved in Europe in the past 18 months, including a BCR-ABL qPCR kit.

About Luminarie Canada Inc.

Luminarie Canada, the Canadian affiliate of Luminarie Pty Ltd, is a pharmaceutical distribution company specialized in the commercialization of innovative, high quality OTC consumer products, OTC medical devices and medical devices used in the hospital network.

For further information, please contact:

Yanick Thibeault
President
Luminarie Canada
Email: [e-mail]
Mobile: [phone]

Benot Hbert, Ph.D., MBA
Consultant for Luminarie Canada
Email: [e-mail]
Mobile: [phone]

 

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