7th Jul 2015 08:03
LONDON (Alliance News) - Omega Diagnostics Group PLC Tuesday said there is a stability issue with the storage of its Visitect CD4 product, which is a disposable, rapid test designed to test whether people with human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS) can be moved onto antiretroviral treatment.
Omega Diagnostics shares were down 20% at 18.22 pence on Tuesday morning.
CD4 cells, which are vital in defending the human body against infection, come under attack by the AIDS virus once a person is infected. Antiretroviral therapy is not a cure for HIV, though it can help people with the virus to live longer by preventing it from multiplying and destroying the CD4 cells.
The medical diagnostics company, which focuses on allergy, food intolerance and infectious disease, said it is evaluating the Visitect CD4 final product stability prior to carrying out further field evaluation.
The company had moved into the verification and validation process after completing the internal investigation phase.
That phase includes testing the longer-term stability of in-house manufactured finished devices, according to Chairman David Evans, who said it couldn't begin until the selection of the manufacturing process.
"We have determined within the last few days that there is a stability issue with finished product that manifests after a period of five weeks of storage at room temperature. This requires further investigation as to root cause, which is being undertaken now," Evans said.
"Verification and validation is a necessary process undertaken to establish finished product performance, and we will not put product back into field evaluation until we have addressed this issue and the product meets the needs of the target market," Evans said.
The news came as Omega Diagnostics said that pretax profit increased to GBP684,258 in the year ended March 31, compared with GBP543,041 in the prior year.
Food intolerance sales grew by 15% to GBP6.0 million, while allergy and autoimmune sales were down to GBP3.1 million from GBP3.5 million. Infectious diseases sales increased by 4% to GBP2.6 million.
By Samuel Agini; [email protected]; @samuelagini
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