6 June 2024

GeneTex’s Recombinant Monoclonal Antibodies for IVD Design

GeneTex’s recombinant antibody production platform and augmented validation strategies are being leveraged to create reagents for diagnostics-related applications, including IHC, lateral flow assay, and ELISA.

In Vitro Diagnostics (IVD) are tests carried out on biological samples acquired from human or veterinary sources to assist in the diagnosis and treatment of biomedical conditions. The sensitivity, specificity, and performance consistency of the reagent components of an IVD assay are therefore crucial for accurate diagnoses and therapeutic decision-making. Utilizing its recombinant monoclonal antibody production platform and “5 + 1 Pillar” validation protocol, GeneTex is expanding its recombinant antibody catalog with reagents thoroughly validated for common IVD applications, which include immunohistochemistry (IHC), lateral flow assay (LFA), and enzyme-linked immunosorbent assay (ELISA).

HistoMAX™ Antibodies

IHC is an indispensable application routinely employed in academic and clinical research as well as in patient care. In addition to the quality of tissue section preparation, the pivotal component determining the reliability of IHC data is the suitability of the antibody used. This can only be assessed through strict and focused reagent validation for this assay.

With this in mind, GeneTex is proud to introduce its HistoMAX™ product line consisting of monoclonal antibodies specifically vetted for IHC (see examples below). All of these reagents were extensively evaluated using formalin-fixed human normal tissues (more than 70 different sections) and cancer tissue arrays to guarantee specificity and best-in-class performance. Only antibodies that have passed these stringent performance criteria for IHC are added to the HistoMAX™ portfolio. Presently, the catalog includes more than 140 products, with new antibodies (and an increasing number of fully recombinant reagents) always being added.

Lateral Flow Assay Antibodies

LFA is an ideal chromatographic technique that offers outstanding advantages in point-of-care testing (POCT) with rapid detection, low cost, and comparatively uncomplicated manufacturing. Nevertheless, both the capture and detection binders (ideally monoclonal antibodies) must be matched empirically with acceptable sensitivity and specificity. GeneTex has focused on manufacturing matched LFA-validated monoclonal antibody pairs (with the majority being recombinant) that target SARS-CoV-2 nucleocapsid, influenza A and B nucleoproteins, respiratory syncytial virus (RSV) nucleoprotein, human papillomavirus type 16 (HPV16) E7 protein, and African swine fever virus (ASFV) p54 protein. These efforts are being expanded to produce additional antibody pairs against other viral pathogens to expedite new POCT device development.

ELISA Antibodies

As with LFA, GeneTex is also growing its catalog of matched monoclonal antibody pairs for sandwich ELISA as well as single antibodies validated for ELISA. Presently, the company offers well over 100 ELISA antibody pairs and kits and new reagents will continue to augment the ELISA product listing, as testing for performance in indirect, direct, and sandwich ELISA is routinely done as part of GeneTex’s antibody characterization program. Recent pairs for IL-6, ANP, and enterovirus D68 VP1 detection highlight the diversity of novel matched monoclonal antibody pairs that are being developed (see specific links below).

In summary, GeneTex’s integrated monoclonal and recombinant monoclonal antibody manufacturing and validation platforms are ideally suited for the creation of sustainable, scalable, and consistent reagents appropriate for different IVD applications widely used in biomedicine.