Unity Fetal Risk™ Screen
UNITY Fetal Risk Screen leverages cell-free DNA to provide direct insights to the fetus, translating to ~3x increase in detection of affected pregnancies compared to traditional carrier screening.
Fetal risk for recessive conditions via cell-free DNA
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Traditional Carrier Screen
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
Learn more
Less than 1% screen high risk
With earlier insights, diagnostic testing including Chorionic Villus Sampling, can be considered
Know More. Know Early. Timely treatment leads to optimal outcomes. Provide peace of mind for 99% of pregnancies.
42,000+
study cohort
cases collected from 811 unique practices across 45 US states 17.9% reflexed to sgNIPT
96.0%
key result
accurately detect affected pregnancies
Traditional Carrier Screen
- 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
Less than 1% screen high risk
With earlier insights, diagnostic testing including Chorionic Villus Sampling, can be considered
Know More. Know Early. Timely treatment leads to optimal outcomes. Provide peace of mind for 99% of pregnancies.
100% correlation of highest risk cases
100% correlation of highest risk cases
All cases identified as a 9 in 10 risk were confirmed to have an affected child via neonatal outcomes
Proven to maximize detection of affected pregnancies in a general obstetric population
The risk identified with UNITY Fetal Risk Screen is strongly correlated with the likelihood of an affected pregnancy
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% |
Maximize Detection. Minimize Risk.
This study builds upon earlier findings to confirm that carrier testing with reflex to sgNIPT is highly accurate for general population screening. Given this high accuracy and an NPV of 99.8%, this workflow should be considered as an option for most of the general pregnant population.
These rare variants are more common in non-European populations:
study cohort
cases collected from 811 unique practices across 45 US states 17.9% reflexed to sgNIPT
key result
accurately detect affected pregnancies
neonatal outcomes obtained
at least 75 outcomes per condition
negative predictive value (NPV)
trust in a negative result
100% concordance to neonatal outcomes across multiple studies.
Confidence in results with UNITY Aneuploidy
Provide reassurance to 99% of patients
- Detect more affected pregnancies than traditional carrier screening in a real life scenario
- Does not require a male partner sample so is not limited by factors such as misattributed paternity (10%)14 or lack of partner follow up (58%)
42,000+
study cohort
cases collected from 811 unique practices across 45 US states 17.9% reflexed to sgNIPT
96.0%
key result
accurately detect affected pregnancies
Detect ~3x more affected pregnancies with UNITY Fetal Risk compared to traditional carrier screening
Interested in learning more about
Unity Fetal Risk™ Screen
?
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.