Successful completion of CD4 Technology Transfer

RNS Number : 9548Z

Omega Diagnostics Group PLC

13 February 2014

 



Omega Diagnostics Group PLC

("Omega" or the "Company")

CD4 Update - Successful completion of Technology Transfer

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces the successful completion of its CD4 technology transfer project with first in-field evaluations to start next month.

Further to the announcement made in December 2013 regarding the first reference batch, the Company announces that it has successfully completed a three batch-validation of its manufacturing protocol.  The results from tests on patient samples with the second and third batches have demonstrated that Visitect® CD4 meets the design parameters of clinical sensitivity, specificity, accuracy and reproducibility.

This is a major milestone towards full commercialisation of the Visitect® CD4 test and accordingly, the product is now available for full in-country field evaluations.  The first evaluations are expected to commence next month in Kenya and Mozambique. Separate claim-support studies are planned to CE-Mark the test which will take place over the next few months.

The devices for the second and third batches were assembled using the Company's Alva-based manufacturing facility which was built last year, and this completes the equipment validation process required under ISO 13485.  Accordingly, the Company now has a fully validated production facility, currently capable of manufacturing over seven million devices per annum. 

Commenting on the completion of technology transfer, Andrew Shepherd, CEO of Omega said: "We are delighted to have successfully completed the milestone of technology transfer for this innovative product.  This now unlocks the full potential of Visitect® CD4 which is eagerly awaited by the market."

Contacts:

Omega Diagnostics Group PLC		Tel: [phone]
Andrew Shepherd, Chief Executive		www.omegadiagnostics.com
Kieron Harbinson, Group Finance Director
Jag Grewal, Group Sales and Marketing Director
finnCap Ltd		Tel: [phone]
Geoff Nash/Christopher Raggett (Corporate Finance)
Stephen Norcross/Mia Gardner (Corporate Broking)
Walbrook PR Limited	Tel: [phone] or [e-mail]
Lianne Cawthorne	Mob: [phone]
Paul McManus	Mob: [phone]

 

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