Gene Solutions

Track record

With over three million genetic tests delivered worldwide since 2017, Gene Solutions is recognised for its proprietary research, CAP-accredited laboratories, and contributions to advancing precision medicine through clinical studies, technology development, and regional collaborations.

Where it sits in the Genique stack

Gene Solutions covers library preparation, analysis and reporting for cell-free DNA applications. It is the liquid-biopsy line of the stack, and it is delivered as a defined test rather than as a platform to build on.

• The tests: SPOT-MAS for multi-cancer early detection, K-TRACK and K-4CARE for tumour-informed ctDNA monitoring, oncoGS for tumour profiling, and triSure for non-invasive prenatal screening and carrier screening.
• Sample type: plasma for the cell-free tests, which is what puts them beside rather than inside a tissue-based NGS menu.
• What a monitoring test needs first: a baseline from the tumour, through oncoGS or through the tissue-based targeted panels elsewhere in the stack, from SOPHiA GENETICS or Paragon Genomics.
• Statutory constraint: the prenatal line is subject to the PCPNDT Act, 1994. The notice on this page is not marketing copy.

How Genique supports it in India

Supplied and supported by Genique in India as the official distributor.

• Lead time: four weeks from purchase order to delivery.
• Service: handled remotely, by the field application and engineering team in India.
• Training: on site, for as many people as the laboratory needs trained rather than a fixed number of seats. One to two days.
• Consumables: four weeks to replenish.

Regulatory status in India

Gene Solutions supplies the triSure and SPOT-MAS assays, labelled by the manufacturer for research use.

• Labelling: Research Use Only. That holds even where a product carries CE-IVD, CE-IVDR or FDA marking in another jurisdiction, because an approval granted elsewhere does not travel to India.
• CDSCO: nothing on this page is approved or licensed by the Central Drugs Standard Control Organisation as an in-vitro diagnostic device.
• What accreditation does and does not cover: accreditation of a laboratory evidences the quality system and the method validation under which work is performed. It does not change the regulatory status of an assay.
• What this means for a NABL laboratory: the assay is run under a validated method belonging to the laboratory, and the PCPNDT position stated elsewhere on this page applies to triSure in full.