IMPORTANT for Manufacturers of SARS-CoV-2 Assays
There is a regulatory obligation from the Medicines & Healthcare products Regulatory Agency (MHRA) to manufacturers of SARS-CoV-2 assays that they monitor and validate their aassays as new variants are identified.
Manufacturers of products that are on the UK market are obliged to have a Post Market Surveillance Plan (PMSP), where the manufacturer continuously monitors, investigates, and assesses emerging variants and whether the manufacturer’s assay remains effective against detecting the new variants.
Manufacturers of molecular assays are required to submit a monthly report to the MHRA, containing a risk assessment of their assay’s molecular biology, including an assessment of the primer, probe/ other oligonucleotide target sequences versus newly identified variants. The report should:
1) Provide information on whether any gene targets in the diagnostic assay is affected by the variant.
2) Provide references so that data used in the assessment can be independently identified, for example by the MHRA.
3) if the performance of the Manufacturer’s assay is directly and negatively impacted by new variant(s) then the MHRA needs to be immediately alerted.
Your report
As a developer and manufacturer of molecular assays where new variants are expected to emerge, for example, SARS, Influenza, etc., you are regulatory obliged to develop a workflow for a Post Market Surveillance Plan (PMSP), including reporting to and alerting regulators.
The plan should include:
1. Biweekly in-silico assessment against new variants.
2. Continuous scientific and literature post-market intelligence gathering.
3. External Quality Assessment, which can be performed by ZP/Biostella.
4. Use of reference materials to test the assay against.
5. A plan to report potential safety concerns to regulators, such as MHRA, FDA, etc.
Biostella Monthly Manufacturers Variant Report Generator (MMVRG)
Biostella has a bespoke monthly report generator that mines the literature, compares against the specific molecular biology of the manufacturers molecular assay, and produces a report specific to the manufacturers assay and the emergence of monthly variants. This report is intended to support the manufacturer to stay compliant with the monthly reporting requirements.
