Genedrive gets CE-IVD marking for new system platform
29th Sep 2021 13:08
(Sharecast News) - Near-patient molecular diagnostics company Genedrive announced on Wednesday that the new-generation 'Genedrive System' platform, which was developed to support the commercial launch of the 'Genedrive MT-RNR1' ID kit, had now received CE-IVD marking in anticipation of launch in the UK and the European Union.
Read moreGenedrive to seek CE mark clearance for MT-RNR1 assay
31st Aug 2021 12:05
(Sharecast News) - Molecular diagnostics company Genedrive said on Tuesday that it will soon launch its MT-RNR1 assay, used for the detection of antibiotic-induced hearing loss in newborns.
Read moreGenedrive makes progress with Covid-19 test development
1st Jul 2021 09:52
(Sharecast News) - Molecular diagnostics company Genedrive updated the market on the development of its 'COV19-ID Kit', a rapid point-of-care molecular test for SARS-CoV-2 detection designed for its 'Genedrive instrument', on Thursday.
Read moreGenedrive Covid-19 test formally approved in India
30th Apr 2021 13:16
(Sharecast News) - Molecular diagnostics company Genedrive announced on Friday that the 'Genedrive 96' SARS-CoV-2 kit had been formally approved by the Indian Council of Medical Research (ICMR).
Read moreGenedrive appointed to PHE microbiology supply framework
19th Apr 2021 12:07
(Sharecast News) - Molecular diagnostics company Genedrive has been successful with its tender to Public Health England (PHE) under Lot 1 of the National Microbiology Framework for diagnostic goods and services, it announced on Monday.
Read moreGenedrive notifies FDA of intent to distribute Covid test
16th Dec 2020 12:16
(Sharecast News) - Molecular diagnostics company Genedrive has notified the United States Food and Drug Association (FDA) of its intention to import and distribute its 'Genedrive 96 SARS-CoV-2 Kit' prior to an emergency use authorisation (EUA) determination, it announced on Wednesday.
Read moreGenedrive gets approval for Covid-19 kit in South Africa
30th Sep 2020 17:21
(Sharecast News) - Molecular diagnostics company Genedrive announced on Wednesday that its 'Genedrive 96' SARS-CoV-2 kit has received approval from the South African Health Products Regulatory Authority, having been submitted for evaluation in June.
Read moreGenedrive revenues tumble as Covid-19 hits pre-existing business activities
10th Jul 2020 10:15
(Sharecast News) - Molecular diagnostics company Genedrive saw revenues tumble in the year ended 30 June due to the impact of the Covid-19 pandemic on pre-existing business activities.
Read moreGenedrive gets CE-mark for Covid-19 test kit
22nd May 2020 13:16
(Sharecast News) - Molecular diagnostics company Genedrive announced on Friday that its 'Genedrive 96 SARS-CoV-2 Kit' was now CE-IVD marked, and available for commercial sale across the European Union, including the UK.
Read moreGenedrives completes manufacturing milestone for Covid-19 test
1st May 2020 16:17
(Sharecast News) - Near-patient molecular diagnostics company Genedrive has completed the last significant manufacturing milestone in the co-development of the 'Genedrive 96 SARS-CoV-2' kit with Cytiva, it announced on Friday.
Read moreGenedrive upbeat on latest results from RNR1 kit testing
3rd Dec 2019 09:39
(Sharecast News) - Near-patient molecular diagnostics company Genedrive announced on Tuesday that in its case-control clinical validation, the antibiotic-induced hearing loss assay - the 'Genedrive MT-RNR1 ID' kit - achieved a diagnostic sensitivity of 100% and specificity of 100% on a cohort of 303 samples.
Read moreGenedrive infant hearing loss test gets CE mark
18th Nov 2019 16:00
(Sharecast News) - Molecular diagnostics company Genedrive announced on Monday that its antibiotic-induced hearing loss test, the 'Genedrive MT-RNR1 ID' kit, has obtained CE marking.
Read moreGenedrive loss narrowed after double-digit revenue rise
3rd Oct 2019 10:41
(Sharecast News) - Genedrive on Thursday reported a narrowed annual loss as revenues jumped as its commercial relationship with the US department of defense (DoD) exceeded expectations.
Read moreGenedrive losses narrow despite increased R&D costs
28th Mar 2019 07:59
(Sharecast News) - Molecular diagnostics company Genedrive saw revenues tick ahead slightly in the first half of its financial year but increased research and development costs kept the firm in the red.
Read moreGenedrive makes progress with HCV kit in first half
15th Jan 2019 10:17
(Sharecast News) - Near-patient molecular diagnostics company Genedrive issued an unaudited update for the six months ended 31 December on Tuesday, reporting revenue of £1.5m, up from £1.3m year-on-year.
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