CDSCO Approved Nucleic Acid Extraction & Molecular Diagnostic Devices

Yes. Cambrian Bioworks holds CDSCO IVD certification (MFG/IVD/2025/000069) as well as an IVD certification (Cambri-Benga-KA/M/IVD/-17175), confirming regulatory approval for manufacturing and supplying in vitro diagnostic devices in India. The company is also ISO 13485 and CE-IVD certified.

The product range supports FFPE (Formalin-Fixed Paraffin-Embedded) tissue for gDNA extraction, whole blood for both gDNA and RNA isolation, and additionally cell cultures and bacterial cells. This broad compatibility makes the kits suitable for oncology, infectious disease, and transcriptomics workflows.

Extraction times are optimized for speed: the FFPE gDNA and Whole Blood gDNA kits complete on-deck processing in 28 minutes, while the Blood RNA Isolation Kit takes 50 minutes including lysis. All workflows run on the automated Manta cartridge-based system, minimizing hands-on time significantly.

Extracted DNA and RNA are suitable for a wide range of applications including Next-Generation Sequencing (NGS), PCR and qPCR assays, microarray analysis, mutation analysis, RNA-Seq, transcriptome profiling, gene expression studies, and oncology biomarker research. High-quality purity ratios and RIN values are validated for these sensitive workflows.

The Manta system supports flexible throughput of 1 to 32 samples per run, allowing labs to process a single sample without wasting reagents or process up to 32 samples simultaneously. This eliminates batching pressure and is ideal for both low-volume clinical labs and high-throughput diagnostic centers.

Cambrian Bioworks' CamSelect Long™ magnetic bead technology delivers higher nucleic acid recovery, cleaner extracts, and more consistent yields compared to traditional spin-column methods. It produces high molecular weight DNA with A260/280 ratios of 1.8–2.0 and RNA with RIN values of 8.6–9.7, validated on the Agilent Tapestation System.