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Omega Diagnostics Identifies 'Stability Issue' in Long-Awaited HIV Test Kit

Omega notes in a progress report it has been working “since the last update” to resolve a “stability issue which manifested after five weeks storage at ambient temperature”

Medical diagnostics firm Omega Diagnostics has warned a “stability issue” has slowed progress in commercialising its long-awaited Visitect CD4 HIV testing kit.

Omega notes in a progress report it has been working “since the last update” to resolve a “stability issue which manifested after five weeks storage at ambient temperature”.

The company had noted in a July update is had brought manufacturing of Visitect CD4 back in-house after reporting “sub-optimal” field trials in Kenya.

The AIM-listed company reported a “manufacturing variability” issue with Visitect CD4 last October which had slowed commercialisation of the product.

Omega notes in a trading update today: “We have recently discovered an ambient temperature effect which manifests as a change in test line signal, with no corresponding change in reference line signal.

“We have identified the step responsible for this temperature effect, and our immediate focus now is to complete the testing needed to determine which component from this step causes it.

“Once the component is identified and replaced or adjusted, the verification and validation process will re-commence.

“We remain confident of resolving this, although the ultimate timing remains uncertain at this stage and we will provide further updates as soon as we can.”

Omega, which recently completed fit-out of a 20,000 sq.ft laboratory and manufacturing space in India as a second manufacturing site for Visitect CD4, said the manufacturing equipment installed is

“generic for most lateral flow rapid tests” and will “provide a low cost manufacturing base for a broader range of infectious disease tests”.

The company said it has selected a range of malaria tests to work on, “as soon as the equipment has completed validation”.

Omega which provides medical diagnostic test kits for allergies, food intolerance and infectious diseases, notes in a trading update it expects revenues will be up eight per cent in the six months to September 30 to £6.15 million for the period, (H1 2014: £ 5.69 million).

On a constant currency basis, Omega expected first half revenues are up 11 per cent.

The company said first half profits are “expected to be similar” to the £0.56 million reported for the first half of last year, as an increase in gross profit has covered a rise in management costs which Omega said is “in line with growth plans”.

Revenues from food intolerance activity are expected to be up 20 per cent to £3.34 million from “significant gains in business throughout the Americas and the Middle East plus a number of markets in Asia and the Far East”.

In infectious disease/other, first half revenues are expected to be up 13 per cent to £1.22 million as a result of growth in the UK and Africa.

Omega said it continues to make “good progress” with its allergy development programme, with a further four allergens optimised in the first half, taking the number of allergens whose performance matches with its IDS-iSYS assay test product to 36.

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