Inbiome Nabs IVDR Certification for 'Molecular Culture' Bacteria Test

Original from: 360dx

Dutch diagnostics firm Inbiome said Friday that it has received certification under the EU's In Vitro Diagnostic Regulation for a PCR-based test to aid the identification of more than 200 bacterial species from patient samples, with results within five hours.

The Amsterdam-based firm's Molecular Culture ID test is used for the detection and identification of bacterial species in samples including synovial fluid, cerebrospinal fluid, and tissue biopsies. It said that the results are available within hours compared to two to five days for culture-based test results, allowing earlier decisions on treatments and reductions in unnecessary antibiotic use.

The firm said on its website that Molecular Culture ID consists of two multiplex PCR assays, one specific to Firmicutes, Actinobacteria, Fusobacteria, Verrucomicrobia, and Bacteroidetes and the other specific to Proteobacteria.

The company announced in September that it had also gained US Food and Drug Administration breakthrough device designation for the instrument-agnostic test, and company officials said at the time that they aim to achieve same-day diagnosis for all infectious diseases by 2030. Breakthrough device designation helps firms to move more quickly through the FDA's regulatory processes. Inbiome plans to enter the US market in 2026.

Inbiome said on Friday that its test achieves high specificity by analyzing the length of a conserved genetic region that is present in all bacteria. The firm further explained on its website that its approach relies on the identification of species-specific length polymorphisms of the bacterial interspace region and phylum-specific sequence polymorphisms of 16S rDNA.

Inbiome CEO Dries Budding said in a statement that the test reduces diagnostic delays and identifies pathogens that other tests miss, "enabling targeted treatments from the first critical hours."

The company said that it plans to use the proceeds of an upcoming funding round to accelerate its commercial and R&D operations, and that includes expanding its partnerships with hospitals and labs.

Inbiome noted that the results so far from ongoing clinical trials at Emma Children's Hospital at Amsterdam University Medical Center demonstrate that use of the test can help healthcare providers reduce unnecessary antibiotic administration to newborns with fever.

Source: Inbiome Nabs IVDR Certification for 'Molecular Culture' Bacteria Test