This advance notice is not an invitation to tender, but it is a market consultation for the upcoming procurement. No tenders will be submitted and no advance registration will be made for the actual tender based on the advance procurement notice.

This advance notice does not obligate the Acquisition Unit of the Joint Authority of the Helsinki and Uusimaa Hospital District for any actions. The responses to this information request do not obligate the acquisition unit to any service acquisitions nor to commit proceeding with the procurement. The acquisition unit also does not commit to the information provided in this market consultation or its attachments, as the subject or requirements of the procurement may change in the preparation of a procurement procedure.

HUS Group (also “HUS”) is preparing a procurement of large cancer gene panel for analysis of somatic genetic alterations in cancer (also "supplies"). The aim of this market consultation is to gather information on potential tenderers and the features of available supplies.

Laboratory of Genetics at HUS (Helsinki University Hospital) Diagnostic Center is an SFS-EN ISO 15189:2022 accredited laboratory providing diagnostic genetic testing services to all patients at Helsinki and Uusimaa Hospital District. The services include analysis of both constitutional samples and malignancies. The laboratory provides sequencing services mainly using local sequencing capacity (Illumina NovaSeq 6000, NovaSeq X Plus, Ion GeneStudio S5 Prime equipment).

Currently, Laboratory of Genetics is seeking for a large cancer panel test for detection of small nucleotide variants (SNVs), indels, gene fusions, copy number variations (CNVs), microsatellite instability (MSI), homologous recombination deficiency (HRD), and tumor mutation burden (TMB) relevant for the genetic profiling of solid tumor samples and/or hematological malignancies. This test is based on analysis of total nucleic acids (RNA and DNA) extracted from paraffin embedded specimens and/or fresh-frozen specimens. Sequencing of the samples is carried out using next generation sequencing (NGS) on Ion Torrent or Illumina NovaSeq sequencers. The number of cancer panel tests performed annually is estimated to be between 500-1000.

The following specific requirements concerning the cancer panel tests are:

• The test is validated for Ion GeneStudio S5 Prime equipment. Yes/No

• The test is validated for Illumina NovaSeq 6000. Yes/No

• The test is validated for Illumina NovaSeq X Plus. Yes/No

• The test is validated for paraffin embedded samples. Yes/No

• The test is validated for fresh frozen tissue samples. Yes/No

• The automatic nucleic acid extraction methods used in the laboratory (Maxwell, QIAsymphony) are suitable for tests. Yes/No

• The gene panel covers the most common cancer genes with clinically relevant alterations i.e. according to WHO classification and cancer type specific guidelines. Yes/No

• The test is intended for solid tumors. Yes/No

• The test is intended for hematological malignancies. Yes/No

• The tests for solid tumors and hematological malignancies are separate products. Yes/No

• The test is validated for cfDNA. Yes/no

• The test for cfDNA is a separate product Yes/No