Unity Fetal RhD™ NIPT
UNITY Fetal RhD NIPT is the only non-invasive test in the U.S. that assesses fetal RhD status.
>90,000+ patients tested since 2020.
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Diagnostic level accuracy, enabling safe and reliable clinical decision making.
Next Generation Sequencing + proprietary molecular counting with QCT™ technology results in unparalleled detection and accuracy of fetal RhD
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500+
clinical samples
with confirmed concordant outcomes, including fetal D-antigen
<0.1%
no-call rate
an informative result for nearly all patients
Diagnostic level accuracy, enabling safe and reliable clinical decision making.
- Up to 1 in 5 screen positive
- Male partner needed to provide a generic reproductive risk of 1 in 4
- >58% of male partners do not follow up with testing
- Most patients will not pursue diagnostic testing especially without a reproductive partner’s results
- Newborn screening can take weeks and requires follow up diagnostic testing
- Neonates are potentially missing the window of opportunity for many critical treatments
UNITY Fetal Risk™ Screen
~40% not detected
~40% not detected
40% of patients will receive a fetal RhD “not-detected” result, indicating that Rho(D) immunoglobulin will not be beneficial for the pregnancy
“Noninvasive determination of fetal Rh status is now possible through the analysis of cell-free DNA in maternal plasma. Up to 40% of Rh D-negative pregnant women will carry an Rh D-negative fetus. In this clinical situation, antenatal anti-D immune globulin [e.g., RhoGAM] administration is unnecessary”
- ACOG Practice Bulletin #181
Current clinical recommendations
- WEEK 10
- Gather paternal sample and analyze genotype. (assuming partner is available)
- WEEK 12
- Partner is negative for K and heterozygous for D (RhD) antigens. Amniocentesis is offered but declined due to risk of complications.
- WEEKS 12–36
- Blood drawn for antibody titer every 2-4 weeks.
- WEEK 37
- Deliver baby and check
UNITY Fetal Risk™ Screen
- WEEK 10
- UNITY Complete with Fetal Antigen NIPT ordered for K (Kell) & D (RhD) antigens.
- WEEK 10
- UNITY Complete with Fetal Antigen NIPT ordered for K (Kell) & D (RhD) antigens.
| Trisomy 21 | Trisomy 18 | Trisomy 13 | Combined Autosomes | |
|---|---|---|---|---|
| Sensitivity | 99.7% | 99.5% | >99.9% | 99.7% |
| Specificity | 99.7% | >99.9% | >99.9% | 99.9% |
| PPV | 90.5% | 97.6% | 73.3% | 90.8% |
| NPV | >99.9% | >99.9% | >99.9% | >99.9% |
>99.9% accuracy across the diverse United States population
UNITY Fetal RhD NIPT determines the presence or absence of rare variants such as RHD(Ѱ) and RHD-CE-D hybrid genes. THIS MATTERS.
These rare variants are more common in non-European populations:
clinical samples
with confirmed concordant outcomes, including fetal D-antigen
no-call rate
an informative result for nearly all patients
of the Black population
carries the RHD(Ѱ) or RHD-CE-D hybrid gene that presents as Rh negative5
of Asians
carry the RHD-CE-D hybrid gene6
100% concordance to neonatal outcomes across multiple studies.
Confidence in results with UNITY Aneuploidy
500+
clinical samples
with confirmed concordant outcomes, including fetal D-antigen
<0.1%
no-call rate
an informative result for nearly all patients
Interested in learning more about
Unity Fetal RhD™ NIPT
?
Contact us for more information by filling out the form and our team will be in touch with you soon.
Frequently Asked Questions
UNITY Complete takes advantage of a pregnancy's DNA (circulating cell-free DNA, ccfDNA) floating in the maternal bloodstream to assess for genetic changes. Some of these genetic changes are extremely small - like changes to single genes that can cause recessive conditions. Some of these genetic changes involve the presence of an entire extra chromosome (aneuploidies).
Our specialized QCT technology enables us to be able to count the genetic information we see from both mom and baby in a blood sample, and determine if there are differences that could indicate a baby has a higher chance of being affected with one of these conditions.
UNITY Complete offers comprehensive genetic screening from a single maternal blood sample - no partner sample required. The specific insights you receive depend on the tests you order based on your patient’s clinical needs.
UNITY Aneuploidy™ Screen checks for chromosomal conditions caused by extra or missing chromosomes, including Trisomy 21, Trisomy 18, Trisomy 13, Monosomy X, XXX, XXY, and XYY. This test also provides fetal sex determination and, for twin pregnancies, identifies whether the twins are identical or fraternal.
Depending on your patient's clinical history, you may also order:
• UNITY Fetal RhD NIPT for patients with RhD-negative blood type.
• UNITY Fetal Antigen NIPT for patients who are alloimmunized to certain antigens.
• 22q11.2 microdeletion analysis
UNITY Fetal Risk™ Screen offers two panels to assess carrier status for up to 14 recessive and x-linked conditions:
• ACOG Guideline Panel (5 conditions): Screens for conditions recommended by the American College of Obstetricians and Gynecologists (ACOG), such as cystic fibrosis, spinal muscular atrophy, sickle cell disease, alpha-thalassemia, and beta-thalassemia.
• ACOG Guideline PLUS Panel (14 conditions): Includes all conditions from the ACOG Guideline Panel, plus additional conditions prevalent in Ashkenazi Jewish and pan-ethnic populations such as Tay Sachs Disease, DMD-Associated Dystrophinopathies, Phenylalanine Hydroxylase Deficiency (PKU), and others.
If a patient is found to be a carrier for any of these conditions, fetal testing will automatically be performed using cell-free DNA to assess the likelihood of the fetus being affected. The fetal risk result will indicate whether the risk is low or high for each condition. Please note that fetal risk assessment may not be available for certain cases, such as twin pregnancies or those involving egg donation.
Additionally, you may choose to order carrier screening for Fragile X syndrome. If the patient is a carrier, our assay can perform cell-free DNA analysis to determine the fetus's sex, as male fetuses are at a higher risk of developing Fragile X syndrome.
We believe all pregnant patients should have access to UNITY Complete.
We accept ALL insurances, including Medicaid, and are in-network with the majority of insurance plans across the U.S. We understand that each patient's insurance and financial situation is unique. Our dedicated patient services team is available to assist with payment plans or financial assistance for eligible patients. If you have any questions about costs or how to support your patients, please email us at support@unityscreen.com or call 650-460-2551.
UNITY Complete is ordered by your healthcare provider. If you decide you want UNITY Complete, please call us at 650-460-2551 or email us at support@unityscreen.com and we can get your provider the information they need to get started.
UNITY Aneuploidy Screen results are typically reported as either low-risk or high-risk.
Low-Risk Fetus: This indicates a very low chance that the pregnancy is affected by the conditions tested, though it does not completely eliminate the possibility.
High-Risk Fetus: This indicates an increased likelihood that the pregnancy may be affected by a specific condition. In the case of a high-risk result, follow-up testing such as chorionic villus sampling (CVS), amniocentesis, or post-birth evaluations is generally recommended.
Important: A high-risk result does not guarantee an unhealthy pregnancy and does not rule out other genetic conditions or birth defects.
UNITY Fetal Risk Screen evaluates maternal carrier status for various conditions. If the patient is identified as a carrier, fetal risk assessment will be automatically performed using cell-free DNA. The results will provide either a low-risk or high-risk determination for each condition tested.