The R&D team has been busy filling out our Clinical Diagnostics portfolios with new and enhanced product offerings over the past quarter.
For the 4th time, the LGC Clinical Diagnostics Stanford sponsored research agreement has been extended for another year. This exclusive agreement provides LGC access to Stanford Medical Center’s high risk pregnancy center patients to source blood samples that are used to develop and manufacture catalog and custom NIPT products in the clinical genomics portfolio. In addition to usual chromosomal aneuploidies T13, T18 and T21, this year’s goal is to identify samples for other rare genetic disorders like microdeletions that are in high demand as quality control materials and for proficiency testing throughout the world. In addition to clinical samples, this year’s program is expanded to include maternal fetal wellness biomarkers for early intervention.
Expanding the ACCURUN Serology portfolio, LGC CDx released ACCURUN® 2 SERIES 2900 Multi-Marker Positive Control, ACCURUN® 51 Series 3000 Multi-Marker Hepatitis Positive Control 1, and ACCURUN® 25 Series 2000 ToRCH IgG Positive Control. All three are CE/IVD products approved for sale in Europe, UK and Australia. They have been “refreshed” to update the product’s analyte concentrations to optimize for current Tier 1 diagnostic assays such as Abbott Alinity, Roche cobas and Diasorin Liaison. In addition, a completely new ACCURUN product, ACCURUN® Anti-SARS-CoV-2 IgM Controls Kit, was released. This product helps complete the SARS-CoV-2 portfolio for serology.
For Clinical Genomics, the team released Seraseq® gDNA TMB Reference Panel Mix. This is a panel to help customers optimize and standardize their TMB scoring. TMB is the level of somatic mutations in a tumor, and is a biomarker to predict patient response to immune checkpoint inhibitor therapy. Seraseq gDNA TMB Reference Panel Mix, which has been extensively validated using WES and can be used to guide TMB score assessment using targeted panels, especially around values that may be clinical decision points for different tumor types. It contains 5 vials, with TMB scores of Normal/Baseline, Score 5, Score 10, Score 30, and Score 50.
At API, a pilot study will be initiated this summer for a proficiency program compatible with Meridian Bioscience’s BreathID Hp One, a non-invasive urea breath test for the detection of Helicobacter pylori. Simulated patient breath samples are provided in sealed bags and allow the laboratories to measure the changes in 13CO2/ 12CO2 ratio of exhaled breath though Molecular Correlation Spectrometry. A high ratio of 13CO2 to 12CO2 can be associated with increased urease production, which is indicative of an active H. pylori infection in the stomach. This sample type, breath, is unique for clinical proficiency providers and marks a first of its kind proficiency program for API.
Design Ready (DR) lot formulation is complete for all products in the Roche Mass Spectrometry Development project. Evaluations are proceeding at Roche, with the next stage of product development scheduled for Q4 pending DR lot performance data.
A product development kaizen was held in Copenhagen to determine a critical path for the Radiometer Cardiac Control project. Pilot batch evaluation data was received and the product is performing as intended. Additional testing is required at RMED to determine performance on the new NT Pro BNP assay, which is also in development.
Raw material sourced from Maine is currently under evaluation at TCD to determine its suitability for use in the formulation of Multichem A1c, as significant growth in this product over the last 12 months has led to raw material procurement difficulties. Initial evaluation data demonstrated the material is performing as intended, but further tests are ongoing to assess stability performance.
A U.S.-only Multichem ID-B product is required for launch in October. The design project is currently underway to introduce new list number leveraging data generated as part of the original Multichem ID-B design.
