FDA clears Axis-Shield assay to diagnose RA

The FDA has cleared a new version of Axis-Shield's test for rheumatoid arthritis. The kit increases the assay range and contains changed components for reduced manufacturing costs, according to a company release.

"The clearance of our new anti-CCP assay by the FDA is further validation of Axis-Shield's strong track record of working closely with regulators to broaden our offering of high-margin diagnostics in areas of clinical need, both to the laboratory market and at the point of care," said CEO Ian Gilham. First half of 2011 sales of Axis-Shield's original anti-CCP assay contributed £2.3 million ($3.77 million) to revenues.

The clearance also could aid Axis-Shield as it's being pursued by U.S. rival Alere. The U.K. company has rebuffed Alere's advances to buy it for £230 million ($375 million), a price it regards as inadequate.

Alere has tried appealing to Axis-Shield shareholders, saying its bid offers certainty, according to the Scotsman. "Shareholders are being asked to put their faith in a management team who have a track record of not delivering on expectations," spokeswoman Ginny Pulbrook said of the current team. She reminded shareholders of analysts downgrading pre-tax profit forecasts and problems the company has had in gaining regulatory sign-offs in the U.S. in the past. But Gilham has defended his company, saying it was in a strong position.

Axis-Shield recently revealed it was still on track to launch its lipid test in Europe before the end of the year and to apply for regulatory clearance for the U.S. early next year. The test would compete with an offering from Alere, who is said to also be interested in Axis-Shield's Afinion machine, which can run several tests on a single sample, Scotland on Sunday notes.

Collins Stewart analyst Julie Simmonds said a takeover bid of about £295 million ($483.3 million) would be a "a more-reasonable value," the Scotsman notes. And she isn't alone in saying a higher price may be warranted. "Ultimately, considering the strategic implications from the transaction--it eliminates a solid competitor--and the synergies that could be developed, we believe Alere will likely raise its bid in order to acquire Axis-Shield," explained Nicholas Jansen, an analyst at Raymond James & Associates, as quoted by Scotland on Sunday.

- get more from Axis-Shield's release
- see the Scotsman article
- check out the Scotland on Sunday report
- and here's a Scotsman interview with CEO Ian Gilham