CDSCO Approved Diagnostic Kits & Nucleic Acid Extraction Products in India

CDSCO (Central Drugs Standard Control Organisation) is the national regulatory authority under India's Ministry of Health & Family Welfare. It regulates the import, manufacture, and sale of drugs, cosmetics, diagnostics, and medical devices in India. CDSCO approval is mandatory for in vitro diagnostic (IVD) kits used in clinical settings, ensuring safety, efficacy, and quality standards are met.

Cambrian Bioworks offers kits for FFPE tissue (Cambrian FFPE gDNA Isolation Kit), whole blood for both DNA (Cambrian Whole Blood gDNA Isolation Kit) and RNA (Cambrian Blood RNA Isolation Kit), as well as cell cultures and bacterial cells. This versatility supports oncology, genetics, infectious disease, and transcriptomics workflows in a single automated platform.

The extracted nucleic acids are validated for PCR, Next-Generation Sequencing (NGS), microarray analysis, RNA sequencing (RNA-Seq), transcriptome profiling, BCR-ABL testing, and mutation analysis. High-purity outputs with A260/280 ratios of 1.8–2.0 and RIN values of 8.6–9.7 ensure reliable performance in sensitive molecular diagnostic and research applications.

The Cambrian FFPE gDNA and Whole Blood gDNA Isolation Kits complete extraction in 28 minutes on the Manta platform after lysis. The Blood RNA Isolation Kit has a 50-minute on-deck time, including a 40-minute lysis step. All workflows are fully automated, significantly reducing hands-on time compared to traditional spin-column methods.

Manta is Cambrian Bioworks' compact, automated nucleic acid extraction instrument that uses a cartridge-based system. All three kits — FFPE gDNA, Whole Blood gDNA, and Blood RNA — are designed to run on the Manta platform. It accommodates 1 to 32 samples per run, features a touchscreen interface, remote monitoring, and fits inside a biosafety hood.

Yes. The pre-filled, non-reusable cartridge design allows processing of even a single sample without wasting buffers or plastics. This is especially valuable in oncology where FFPE samples are scarce, and in clinical settings where batching is not practical. Throughput can scale flexibly from 1 to 32 samples within a single run.