Genedrive (GDR)

Sector:

Health Care

Index:

FTSE AIM All-Share

40.50p
   
  • Change Today:
      0.90p
  • 52 Week High: 147.58p
  • 52 Week Low: 17.50p
  • Currency: UK Pounds
  • Shares Issued: 91.77m
  • Volume: 18,230,378
  • Market Cap: £37.17m
  • RiskGrade: 747
  • Beta: 0.38

Genedrive gets CE-IVD marking for new system platform

By Josh White

Date: Wednesday 29 Sep 2021

LONDON (ShareCast) - (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.
The AIM-traded firm said the MT-RNR1 assay was used to screen for a genetic mutation called m.1555A>G.

If a baby carrying the mutation was given the antibiotic gentamicin, a common treatment for bacterial infections, it could cause lifelong deafness.

The Genedrive test would allow for the administration of alternative treatments if the mutation was detected, avoiding the impacts and costs of antibiotic-induced hearing loss (AIHL).

Following user feedback from the successful 'PALOH' study, various product improvements and refinements were incorporated into the platform.

Those included informatic and ergonomic improvements, with the new system validated by external users as part of the CE-IVD marking process, meaning it was ready to be deployed initially at key sites in the UK, followed by the EU.

Genedrive said it was now starting its roll-out of the Genedrive MT-RNR1 kit in partnership with Inspiration Healthcare as its distributor in the UK and Ireland, and was expecting its first sales in the autumn.

The company said it estimated the total addressable market in the UK and EU at around £35m, with it recently raising funds to support its commercial activities to drive sales and exploit the "attractive" market.

"Developed in partnership with NHS collaborators, the Genedrive MT-RNR1 Kit and Genedrive System represent several world firsts - the first commercial availability of an MT-RNR1 test, the first use of our new Genedrive platform, and the first use of point-of-care molecular diagnostics in a neonatal urgent care setting," said chief executive officer David Budd.

"The excellent clinical and performance data that supports these new innovations puts us in a strong position for commercial roll out in the UK alongside Inspiration Healthcare, our commercial distributors in the UK and Ireland."

Budd said that, with the EU scheduled to follow early next year, the firm's first EU pilot site was already established, and would serve as a reference site as it targeted selected EU countries.

"The creation, development, and evaluation of the AIHL test and the new Genedrive System to support the kit has been very considered, and we are pleased to be at the forefront of this innovation in patient care."

At 1243 BST, shares in Genedrive were up 0.4% at 25.1p.

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Note 1: Prices and trades are provided by Digital Look Corporate Solutions and are delayed by at least 15 minutes.

Note 2: RiskGrade figures are provided by RiskMetrics.

 

Genedrive Market Data

Currency UK Pounds
Share Price 40.50p
Change Today 0.90p
% Change 2.27 %
52 Week High 147.58p
52 Week Low 17.50p
Volume 18,230,378
Shares Issued 91.77m
Market Cap £37.17m
Beta 0.38
RiskGrade 747

Genedrive Star Ratings

Compare performance with the sector and the market.
more star ratings
Key: vs Market vs Sector
Value
53.33% below the market average53.33% below the market average53.33% below the market average53.33% below the market average53.33% below the market average
61.11% below the sector average61.11% below the sector average61.11% below the sector average61.11% below the sector average61.11% below the sector average
Price Trend
42.54% below the market average42.54% below the market average42.54% below the market average42.54% below the market average42.54% below the market average
26.83% below the sector average26.83% below the sector average26.83% below the sector average26.83% below the sector average26.83% below the sector average
Income Not Available
Growth
57.39% below the market average57.39% below the market average57.39% below the market average57.39% below the market average57.39% below the market average
76.47% below the sector average76.47% below the sector average76.47% below the sector average76.47% below the sector average76.47% below the sector average

Genedrive Dividends

No dividends found

Trades for 03-Dec-2021

Time Volume / Share Price
16:35 367 @ 40.50p
16:30 7,605 @ 40.25p
16:30 2,008 @ 40.25p
16:30 13,783 @ 40.25p
16:29 4,795 @ 41.20p

Genedrive Key Personnel

Finance Director John Rylands

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