The CDx Research and Development team spent the last quarter working on several new products and upgrades to current offerings, boosted by the agreement with Roche.
LGC Clinical Diagnostics is manufacturing products to replace the Roche CalCheck line, in agreement with Roche Diagnostics. The Roche team visited Technopath in week 40 for a project review and planning meeting that took place over two days. Feasibility work completed thus far was reviewed for each product, with agreement to proceed to the next stage of project development for the Steroid and Vitamin D control. Additional feasibility is required for the ISD and TDM control, which will be completed by Q4 2022.
The Cumberland Foreside facility has been collaborating with Technopath on the characterisation of a hemolysate derivative material, which has been completed with data generated to justify its use in the formulation of Multichem A1c. This collaboration will alleviate the procurement difficulties TCD has been experiencing and facilitate the delivery of the product to the end user.
In other Multichem news, Roche have requested an assessment of certain analytes in both Multichem IA Plus and Multichem S Plus, for which TCD currently provides no claim. Feasibility testing and data generation have been completed to support updating the status of these analytes to claimed in the finished device. The Multichem ID-B product for the U.S. has been developed and is scheduled for release soon.
On the Clinical Genomics side, the SeraSeq Myeloid ctDNA Mix was recently released. The Seraseq FFPE HRD Reference material and Seraseq BRCA 1 and 2 are slated for release later this month.
The Molecular portfolio currently has two projects in the pipeline: HEV Positive Control Kit and Babesia Positive Molecular Control Kit. For more detail, look for Katie Huang’s presentation in this week’s Town Hall recording!
