A medical diagnostics company focused on allergy, food intolerance and infectious disease, Omega, has CE-Marked its Visitect range of Malaria tests.
The range comprises of three tests, for detection of HRP2 antigen in P. falciparum, P. falciparum, non-P. falciparum or mixed infections, and for detection and differentiation of P. falciparum and P. vivax.
The tests are available for general sale in the 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,” the company said in a press release on Wednesday.
In addition, Omega said its manufacturing facility in Pune has undergone an annual inspection from the Indian FDA, and that its Manufacturing Licence is valid until January 2021.
Andrew Shepherd, Chief Executive Officer of Omega said: “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.”