IVD contract development & manufacturing
Immunoassay development and manufacturing to IVD standard
Nova Dx develops and manufactures lateral flow, ELISA and chemiluminescence immunoassays under ISO 13485 and WHO-GMP. We operate as a CDMO, a contract manufacturer and an OEM supplier.
- ISO 13485
- ISO 9001
- CE-IVD
- WHO-GMP
- 3Immunoassay platforms: LFIA, ELISA, CLIA
- 179Catalog assays across four ELISA ranges, LFIA and CLIA
- 2Sites: R&D in North Carolina, USA; GMP manufacturing in Hyderabad, India
- ISO 13485Design control applied from feasibility through manufacture
Services
Partnering models
Three engagement models, each operated under the same quality management system.
Contract development (CDMO)
Assay development from feasibility through design verification and transfer into GMP manufacture, for a defined analyte and intended use.
Read more 02Contract manufacturing (CMO)
Technology transfer of a validated assay design into WHO-GMP production, with lot release documentation for every batch.
Read more 03OEM and private label
Catalog assays supplied under your brand: LFIA rapid tests, four ELISA ranges and CLIA reagents, packaged and labeled to your specification.
Read moreProducts
Product catalog
ProLISA™
Clinical IVD · CDSCO
ELISA for infectious disease serology, TORCH, MMR immunity and thyroid function in clinical laboratories.
28 assaysProKINE™
Research Use Only
Cytokine ELISA for human and mouse, using matched antibody pairs on a single platform.
24 assaysProCISION™
Bioanalytics · RUO
Bioprocess QC and residuals, biosimilar PK / ADA / NAb, and GLP-1 bioanalytics.
74 assaysProSENTRY™
Agri-food & veterinary
Residue, mycotoxin and allergen screening for export testing, plus poultry flock serology.
36 assaysLFIA
Rapid tests · IVD
Lateral flow rapid tests for clinical and field use: infectious disease, cardiac markers, hormones and drugs of abuse.
11 assaysCLIA
Chemiluminescence · IVD
Quantitative chemiluminescence immunoassays for open CLIA analyzers: cardiac, fertility and tumor markers.
6 assaysPlatforms
Three immunoassay formats
Development and manufacturing capability across the principal immunoassay formats, selected to match the intended use setting and required analytical performance.
LFIA
Lateral flow immunoassay
Qualitative and semi-quantitative rapid tests for point-of-care and field use. Whole blood, serum, plasma, urine and swab matrices; results in 10 to 20 minutes.
ELISA
Enzyme-linked immunosorbent assay
96-well microplate assays in sandwich, indirect, competitive and bridging formats for clinical, research, bioprocess and food safety laboratories.
CLIA
Chemiluminescence immunoassay
Quantitative reagents for open chemiluminescence analyzers, with the wide dynamic range and sensitivity required for cardiac, fertility and tumor marker panels.
Discuss a development or supply requirement
Submit a brief describing the analyte, format and expected volumes. Our development team will respond with an initial feasibility assessment.