YGEN.L Share News (YGEN)

(Sharecast News) - Molecular diagnostics company Yourgene has appointed Immuno-Biological Laboratories, a supplier of in-vitro diagnostic kits for the medical device and research industry, as a non-exclusive distributor for several polymerase chain reaction (PCR) tests across its reproductive health and oncology portfolios in the United States, it announced on Monday.
The AIM-traded firm said the distribution agreement initially included the 'Elucigene' DPYD assay, which tests whether cancer patients could be at risk of "significant and potentially lethal" side effects caused by the 5FU chemotherapy treatment.

In the US, there are around 500,000 5FU chemotherapy treatments carried out per year.

Following the launch of the CE-marked Elucigene DPYD in Europe, Yourgene now had more than 20 hospitals and cancer centre customers routinely using the assay.

As it announced on 14 February, the firm also had approval from the Therapeutic Goods Administration (TGA) in Australia to allow its Australian distribution partner, Southern Cross, to market and distribute the product in that country.

In addition to the DPYD assay, the firm's cystic fibrosis, male factor infertility and invasive aneuploidy diagnostic products would also be sold by IBL-America which, together with the DPYD assay, represented what the board said it believed to be an addressable market of more than £30m per annum.

Yourgene said its products would initially be sold as 'research use only' to the research sector and to CLIA-certified laboratories for in-house validation prior to clinical use, with the potential for full FDA registration later depending on customer demand.

"The appointment of IBL-America is an important pillar within our plans to penetrate the largest diagnostics market in the world with our full portfolio across the whole genomic testing lifecycle," said chief executive officer Lyn Rees.

"We have a strong pipeline of US-oriented product and technology partnerships and look forward to updating investors as these opportunities crystallise."

At 1322 BST, shares in Yourgene Health were down 9.21% at 17.25p.