Menarini’s non-invasive test can detect genomic abnormalities such as common trisomic conditions and genome-wide microdeletions and microduplications down to a size of at least 600 kilobases. Image Credit: H_Ko / Shutterstock.

Menarini has released results from a study showing that its non-invasive prenatal testing technology can detect foetal abnormalities with higher sensitivity and accuracy, compared to standard non-invasive prenatal cell-free DNA (cfDNA) screening.

The non-invasive prenatal test conducts genomic analysis on the foetal cells isolated from maternal blood. The genomic analysis of these foetal cells showed a high concordance with the analysis of foetal cells obtained from invasive diagnostic procedures, as per Menarini.

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The study enrolled more than 1,000 women, whose blood was then analysed for multiple genomic abnormalities, including common trisomic conditions and genome-wide microdeletions and microduplications, called pathogenic copy number variants (pCNVs). The data from the study was presented at the 21st World Congress of the Fetal Medicine Foundation meeting that took place in Portugal from 23 to 27 June.

The trial demonstrated that Menarini’s non-invasive test could detect genome-wide microdeletions and microduplications down to a size of at least 600 kilobases. The test also detected trisomies, beyond core “common” ones detected by standard non-invasive cfDNA analysis.

“This data is exciting because it shows the potential to deliver clinically relevant and actionable information about fetal genomic abnormalities at higher resolution and accuracy than existing screening tests and at an early gestational age when almost no pCNVs are currently detected,” said Jon Hyett, head of maternal and fetal medicine at Liverpool Hospital.

The women’s health sector has seen an increase in awareness and investment in recent years. Multiple companies have invested in developing diagnostics for pregnancy and prenatal testing.

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Nexen Biotech is developing a rapid point-of-care test for Group B streptococci (GBS), StrepSure. GBS bacteria are commonly found in the rectum and vagina and can cause serious infections in pregnant women, young babies, immunocompromised patients, and the elderly. The company plans to start clinical trials for the device in Q1 2025 and the data from the study will inform a 510(k) application with the US Food and Drug Administration.

Another non-invasive prenatal test clinical trial assay is BillionToOne’s Unity assay. The test can screen for the risk of severe haemolytic disease of the foetus and newborn (HDFN). HDFN commonly occurs when rhesus (RhD)-negative maternal blood with antibodies against the rhesus D antigen enters the foetal bloodstream, leading to an immune attack of foetal or neonatal red blood cells. The Unity assay can qualitatively measure the presence of foetal antigens as early as ten weeks.