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One Lambda HLA Software Cleared by US, Canadian Regulators

NEW YORK (GenomeWeb News) – Regulators in the US and Canada have cleared One Lambda's companion software to molecular typing and antibody screening products, the Thermo Fisher Scientific business said late Wednesday.

The US Food and Drug Administration cleared the HLA Fusion Software version 3.0, while Canada's Ministry of Health has also granted the software a Health Canada License.

One Lamba's software is used to help personnel experienced in HLA analysis by suggesting typing and antibody screening results, the company said, adding that HLA Fusion Software version 3.0 is intended as a laboratory aid, not for definitive results.

Thermo Fisher acquired One Lambda, which specializes in transplant diagnostics, in September for $925 million.