MaterniT® 21 PLUS cfDNA (NIPT): Proven performance at nine weeks across different patient weights

Prenatal cell-free DNA screening (cfDNA), also known as noninvasive prenatal testing (NIPT), has reshaped how clinicians approach prenatal genetic screening. For providers caring for pregnant patients, the ability to offer reliable cfDNA (NIPT) screening early in pregnancy is critical for guiding care. MaterniT^® 21 PLUS, one of the most established cfDNA (NIPT) tests, continues to demonstrate strong performance, including high success rates at nine weeks’ gestation and regardless of maternal weight.

Strong cfDNA screening performance at nine weeks’ gestation

Early access to cfDNA (NIPT) screening supports timely counseling and informed decision-making. In a 2022 analysis, Labcorp researchers found that MaterniT 21 PLUS delivers:

• A 98.69% success rate at 9.0–9.9 weeks gestation, supporting early cfDNA (NIPT) testing with a high likelihood of results on first draw
• Consistent cfDNA (NIPT) test success regardless of maternal weight, addressing a perceived barrier in prenatal genetic screening
• Improved performance compared to a 2018 review of cfDNA (NIPT) samples drawn at nine weeks' gestation, based on ad hoc provider feedback and follow-up obtained from diagnostic samples received in our lab

These findings highlight that cfDNA (NIPT) test performance at nine weeks’ gestation can closely align with results from tests performed later in pregnancy, giving providers greater flexibility in when to screen and earlier insight into pregnancy health when time is critical.

Why early prenatal genetic screening matters

Offering cfDNA (NIPT) screening at nine weeks’ gestation has clear clinical benefits:

• Earlier counseling opportunities for patients and families
• More time for follow-up diagnostic testing, when needed
• No significant increased need for redraws compared to >10 weeks’ gestation
• Faster clinical decision-making in pregnancy management

Studies have consistently shown that cfDNA (NIPT) screening provides high sensitivity and specificity for detecting conditions such as trisomy 21, 18, and 13, making it a cornerstone of modern prenatal screening practice.

Addressing fetal fraction and maternal weight challenges

While cfDNA (NIPT) demonstrates strong clinical performance, one of the primary concerns is fetal fraction. Lower fetal fraction, more common earlier in pregnancy or in patients with higher weight, can lead to test failures or redraws. However, updates in technology and bioinformatics have improved performance and success rates at earlier gestational ages.

MaterniT 21 PLUS demonstrates strong performance in this area, helping reduce variability in cfDNA (NIPT) screening success rates across different gestational ages. This is especially important as clinical guidelines evolve. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend offering prenatal screening to all patients, regardless of baseline risk. In addition, both societies support cfDNA as a highly effective screening tool for common aneuploidies.

For clinicians, this means greater confidence in offering cfDNA (NIPT) screening early in pregnancy, even for patients who were previously considered at higher risk for test failure.

Expanding access to reliable prenatal screening

As expectations for prenatal testing for all patients increase, consistent performance across diverse populations becomes essential. MaterniT 21 PLUS helps clinicians deliver on this goal across a broader patient population than other cfDNA (NIPT) screening tests.

Recognizing that early prenatal insights can guide education and pregnancy management, Labcorp remains focused on delivering clinically robust solutions for every patient.