GeneStore France has received approval from France Centre National De Reference Des Virus De Infections Respiratoires (CNR) to market its Detection Expert SARS-Cov-2 RT-PCR test for Covid-19 diagnosis.
The test, which is based on a multiplexed one-step RT PCR approach, delivers results in one hour.
It detects two target regions within the ‘N’ gene of the SARS-Cov2 RNA genome in a multiplex format, the company said.
In addition to a separate reaction for the internal control, the test offers a positive control formed with non-pathogen fragments of SARS-Cov2 viral genome.
GeneStore noted that it is marketing the test at an affordable price of €9.9 ($11.20) to enable higher volumes of worldwide Covid-19 testing.
The test is said to be compatible with most real-time PCR instruments with at least two signal detection channels.
GeneStore global CEO Anubhav Anusha said: “The test enables laboratories in going from purified RNA to results in one hour time.
“In line with our global mission to fight infectious diseases by enabling affordable testing, GeneStore is commercialising the test kit at a highly affordable price of €9.9 and can manufacture one million test kits per month at its France-based manufacturing facility.”
GeneStore France is currently shipping the CE-IVD marked test to the EU, Africa, Latin America and Southeast Asia.
The company is part of the International GeneStore Global consortium composed of ISO13485 / ISO15189 facilities across the world.
It also develops and delivers artificial intelligence (AI)-enabled genomics and proteomics-based solutions for pharmaceutical, healthcare and dermo-cosmetics industries.