Omega Diagnostics Group PLC VISITECT® Malaria CE-Mark & Indian FDA inspection (8169A)

TIDMODX

RNS Number : 8169A

Omega Diagnostics Group PLC

29 March 2017

Omega Diagnostics Group PLC

("Omega" or the "Company")

VISITECT(R) Malaria CE-Mark and successful Indian FDA inspection

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces that it has CE-Marked its VISITECT(R) range of Malaria tests comprising:

   --     VISITECT(R) Malaria Pf (detection of HRP2 antigen in P. falciparum) 

-- VISITECT(R) Malaria Pf/PAN (detection of P. falciparum, non-P. falciparum or mixed infections)

   --     VISITECT(R) Malaria Pf/Pv (detection and differentiation of P. falciparum and P. vivax) 

The successful completion of the verification and validation programme means these tests, manufactured in our facility in Pune, India are available for general sale through business to business channels in those countries which do not require individual product registration. We anticipate achieving additional regulatory approvals within the next 12 months to enable the Company to participate in higher volume tender business.

In addition, the Company confirms that its manufacturing facility in Pune has successfully undergone an annual inspection from the Indian FDA, confirming the facility is compliant with GMP processes for manufacturing, testing, storage and QA processes and that its Manufacturing Licence is valid until January 2021.

Andrew Shepherd, Chief Executive Officer of the Company commented: "This milestone demonstrates our continuing investment in people and infrastructure is beginning to bear fruit. Whilst we expect relatively modest sales during the next financial year to 31 March 2018, we anticipate generating significant demand from the subsequent financial year onwards with high quality products at affordable prices which are both crucial for commercial success."

Contacts:

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

This information is provided by RNS

The company news service from the London Stock Exchange

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March 29, 2017 02:01 ET (06:01 GMT)