Biotome Launches Helitope RUO, Its First Commercial Peptide ELISA Diagnostic Kit
- Aug 3
- 3 min read
Biotome has launched its first commercial product, the Helitope® RUO Rapid Human anti-CagA Epitope IgG ELISA Kit.
Helitope is a peptide ELISA developed for the detection of IgG antibodies to Helicobacter pylori CagA epitopes in human serum. The research-use-only kit is manufactured in Australia by Biosensis and is now available internationally through Antibodies Incorporated.
The launch takes Helitope from years of biomarker discovery and assay development into the hands of researchers for the first time.
Why Helicobacter pylori CagA antibodies matter
H. pylori infects a large proportion of the global population, but different strains are associated with different levels of gastric disease risk.
CagA is a major virulence factor expressed by a subset of H. pylori strains. Infection with CagA-positive strains is associated with more severe gastric disease and an increased risk of gastric cancer. Antibodies to CagA can also remain detectable after the infection has been treated or cleared, making them useful markers of previous exposure to CagA-positive H. pylori.
Existing CagA serology tests often use whole or recombinant proteins. These antigens contain many potential antibody-binding regions, which can introduce cross-reactivity and make it more difficult to distinguish specific anti-CagA responses.
A peptide-based approach to Helicobacter CagA diagnostics
Helitope uses selected CagA-derived peptide epitopes rather than the complete CagA protein. The epitopes originate from multiple strains of H. pylori and were selected for strong recognition by antibodies in CagA-positive samples and low reactivity in negative samples.
Each serum sample is tested against both the CagA peptide surface and a proprietary peptide-based control surface. The control measures sample-specific background binding, helping distinguish anti-CagA antibody reactivity from nonspecific signal.
The resulting assay provides researchers with a more targeted method for studying antibody responses to CagA-positive H. pylori.
Two protocols for different research needs
Helitope is an indirect ELISA that takes less than two hours of operating time. It supports two protocols.
Protocol 1 classifies serum samples as CagA-positive or CagA-negative using an assay-specific cut-off. Up to 22 samples can be evaluated in duplicate against both antigen-coated and control wells.
Protocol 2 provides a semi-quantitative measurement of anti-CagA IgG. A standard curve is generated using the supplied calibrator, and relative antibody levels are reported in arbitrary units. Up to 16 samples can be evaluated using this protocol.
The kit is available in one-plate and two-plate formats. It includes the coated assay strips, a chimeric anti-CagA calibrator, anti-human IgG HRP conjugate, assay and wash buffers, TMB substrate, stopping solution and plate sealer.
According to the published product specifications, Helitope has demonstrated 96% sensitivity and greater than 95% specificity.
From biomarker discovery to market
Helitope is built on patented CagA peptide epitopes discovered and developed by Biotome. Turning those discoveries into a commercial kit required assay optimisation, performance validation, scalable manufacturing, stability testing, quality documentation and an international distribution pathway.
Biosensis provided the manufacturing expertise and quality systems needed to produce the finished kit in Australia. Antibodies Incorporated provides the commercial platform and international distribution network through which researchers can now order it.
Helitope also marks the first commercial use of Biotome’s PepLock™ technology. PepLock-tagged peptides bind directly to the assay surface, improving epitope presentation and sensitivity while reducing the nonspecific background commonly encountered with other conjugation systems.
For Biotome, the launch represents an important step from peptide biomarker discovery to practical research products. Helitope is no longer simply a development program. It is available now for researchers investigating CagA antibody responses, H. pylori infection and gastric disease.
Helitope RUO is for research use only and is not intended for clinical diagnosis.
