Non-Invasive Test Solution Determines Fetal RhD Status from Maternal Plasma

Individuals who lack RhD on their red blood cells are classified as RhD-negative. These individuals may produce antibodies against RhD if they come into contact with RhD-positive red blood cells. RhD incompatibility between a mother and her fetus is the leading cause of fetal and neonatal hemolytic disease (HDFN), and it is the only preventable cause. Since the introduction of anti-RhD prophylaxis in the 1960s, the prevalence of HDFN has significantly decreased. In many countries, all RhD-negative mothers receive treatment to prevent alloimmunization. However, about 40% of these women are carrying an RhD-negative fetus, making prophylaxis unnecessary for many. Determining the fetal RhD status allows clinicians to tailor anti-RhD treatment, ensuring it is administered only when necessary to prevent the risk of hemolytic disease. Now, a reliable, highly sensitive, and accurate test offers non-invasive screening for fetal RhD in pregnant women, helping to avoid unnecessary prophylactic treatments.

The Devyser RHD assay, developed by Devyser (Stockholm, Sweden;) is a highly sensitive CE-IVD labeled QPCR test that provides accurate non-invasive screening for fetal RhD, allowing clinicians to avoid unnecessary treatment. This unique test determines fetal RhD status from maternal plasma as early as the 10th week of pregnancy. The single-exon kit has a turnaround time of less than five hours and requires less than 60 minutes of hands-on time. With early screening, clinicians can assess the risk of HDFN before proceeding with invasive tests like amniocentesis or pregnancy termination. Anti-D prophylaxis can be administered before any procedure that could lead to fetal-maternal hemorrhage or withheld with confidence based on the fetal RhD status. This approach ensures that RhD-negative women avoid receiving unnecessary anti-D prophylaxis about 40% of the time.

The Devyser RHD test has demonstrated high clinical relevance through routine use over the past ten years. It has a diagnostic sensitivity and specificity of ≥99.86%, based on correlation with newborn rhesus serology. The CE-IVD test kit is designed for ease of use, with quick implementation. Only a small amount of genomic DNA is required, and the streamlined laboratory workflow and analysis are ideal for screening purposes. Devyser has received IVDR approval for this non-invasive fetal RhD screening product, marking the first Class D product approval under the new European regulations that came into effect in May 2022. This approval confirms that the Devyser RHD product meets rigorous safety, efficacy, and quality standards.

"National and regional screening programs present significant opportunities for Devyser RHD, one of our fastest-growing products, with an increasing number of users in Europe,” said Devyser CEO Fredrik Alpsten. “We are confident that this approval will further enhance the growth potential of this product. The certification guarantees that our pioneering product continues to deliver trusted results of highest quality to clinicians and patients."

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