Update: email from Omega Group Global Sales and Marketing Director
Food allergy focused medical diagnostic company Omega Diagnostics has gotten ISO certification for the Quality Management System for its Asian subsidiary in India, and it started with the domestic sales of its products.
The AIM listed company said on Wednesday that the certificate covers the production plant in Pune. The company sees this milestone as an important pre-requisite for CE-Marking the malaria and pregnancy tests produced at the site. CE-Marking is still expected to be achieved by the end of the current financial year, the company has said.
This accreditation enables Omega to supply its products for the Indian domestic market with right away, which already sold the first one of the malaria tests.
On the company’s Ffacebook page, it is said that “Omega Visitect Malaria kits are ready for shipment.”
Visitect Malaria is a range of rapid, point-of-care, qualitative immunochromatographic tests for the determination of P. falciparum:
Andrew Shepherd, Chief Executive Officer of Omega said: “We are pleased to have reached this milestone on schedule and look forward to generating a return from the investment to date in this facility.”
We have sent an email to the company asking more details about the value of the first sale.
Jag Grewal, Group Global Sales and Marketing Director at Omega Diagnostics Group, said to us in the email:
“The current first stage of sales is into the Indian domestic market followed by subsequent export sales into the international market once we complete our full CE marking.
Initially sales will be relatively modest until we are able to compete in the large high volume tenders in low-middle income countries (LMIC) often funded by either in-country Ministry of Health departments or external aid agency / NGO’s. This will require WHO pre-qualification approval, a process we are currently engaged in.
It is worth remembering that recent estimates by UNITAID suggested that the demand for Malaria tests was expected to increase by 100m to approximately 380m tests in 2016. Capturing a conservative proportion of this market would represent a significant opportunity for the group.”