The New Standard In Prenatal Care.
One blood test. Direct insights into fetal risk beyond aneuploidies.
UNITY Complete Is Different From The Rest.
The only cell-free genetic screening test that can provide direct insights to fetal risk for both recessive conditions and aneuploidies.
Detect more affected pregnancies
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.1
The only cell-free genetic screening test that can provide a fetal risk for recessive conditions.
UNITY Fetal Risk Screen will first determine if the mother is a carrier for a recessive condition included in the test. If she is determined to be a carrier, single-gene NIPT (sgNIPT) will be performed from the same sample to determine the risk that the fetus is affected for the condition of interest. This is done via cell-free-DNA (cfDNA) and proprietary QCTTM technology. UNITY Fetal Risk Screen is the only screening test that can clarify risk down to 1 in 5,000 or up to 9 in 10 for maternal carriers.
Reassure 99% of pregnant patients, early in their pregnancy
The majority of patients will learn they are at a significantly reduced risk of an affected fetus.
Less than 1% of patients will receive a high fetal risk report, as early as the first trimester.1
One blood draw. One patient bill. Fetal risk for both chromosomal and recessive conditions recommended by ACOG*.
All conditions on our panels are aligned to ACOG recommended conditions REF, with the option to add-on fetal antigens for clinically appropriate patients. No matter which test combination is right for your patient, clear reporting and direct insights to fetal risk make it easy to interpret results.
Designed for a general obstetric population
Conditions align to ACOG recommendations for a general OB population.2,3
Cell-free DNA analysis eliminates need of a male partner's sample.
UNITY complete requires one blood draw from mom, as early as 10 weeks.
UNITY Complete leverages circulating cell-free DNA to provide direct fetal insights for both aneuploidies and recessive conditions. This equates to not only more informative insights, it also overcomes workflow complexities associated traditional carrier screening.
Relying on a male partner’s sample, as is the case with traditional carrier screening has its challenges in clinical practice as it is impacted by factors such as misattributed paternity (10%) or lack of partner follow up (58%).
UNITY Complete
Fetal Risk Screen.
UNITY Complete offers genetic insights for both recessive and chromosomal conditions aligned to recommendations by ACOG.2,3 Patients who are alloimmunized or are RhD- may also benefit from UNITY Fetal Antigen tests.
UNITY Fetal RiskTM Screen
- Cystic fibrosis
- Spinal muscular atrophy
- Sickle cell disease
- Alpha Thalassemia
- Beta Thalassemia
- Fragile X (Optional)
UNITY AneuploidyTM Screen
- Trisomy 21
- Trisomy 18
- Trisomy 13
- Sex Chromosome Aneuploidies:
- X, XXY, XYY, XXX - Zygosity (included for twins)
- 22q11.2 microdeletion (optional)
- Fetal Sex (optional)
UNITY Fetal AntigenTM Tests
(for non-alloimmunized RhD- pregnancies)Stratify which pregnancies may not need Rho(D) immune globulin.
Learn More
(for alloimmunized pregnancies)
Stratify which pregnancies will most benefit from additional monitoring for Hemolytic Disease of the Fetus and Newborn (HDFN).
- Big C, little c, D, E, Fya (Duffy), K (Kell)
Access a Sample Report.
Direct Insights To The Fetus Are Possible With QCT Technology.
Prior to UNITY Fetal Risk Screen, it has not been technically possible to evaluate single-gene disorders from cell-free DNA (cfDNA). Instead, the only option was to determine a reproductive risk from the parents (traditional carrier screening), rather than provide a true fetal risk.
Quantitative Counting TemplatesTM, proprietary to BillionToOne, quantify fetal DNA molecules from cfDNA down to a single base pair. This makes it possible to determine the fetal genotype in maternal blood, providing an individualized fetal risk for each pregnancy.
The Latest Data With UNITY Complete.
Additional Provider Resources.
Product Information
MFM Perspective: UNITY Fetal Antigen NIPT
Test Requisition Form
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 multiple genetic insights from a single maternal blood sample. The results you receive will depend on which tests your healthcare provider orders. UNITY Aneuploidy NIPT screens pregnancies for chromosome conditions caused by extra or missing chromosomes including trisomy 21, trisomy 18, trisomy 13, and monosomy X. This part of the test can also tell you the predicted sex of the baby and if there is a different number of sex chromosomes (XXX, XXY, XYY).
Depending on your clinical picture, your doctor may also order UNITY Fetal RhD NIPT for moms who have a RhD- blood type or UNITY Fetal Antigen NIPT for moms who are alloimmunized to certain antigens.
UNITY Fetal Risk Screen determines if a pregnant person is a carrier for cystic fibrosis, spinal muscular atrophy, sickle cell disease, alpha-thalassemia, or beta-thalassemia. If you're found to be a carrier for one of these conditions, the fetal DNA will be screened to determine if there is a high-chance or a low-chance for a pregnancy to be affected with a condition.
In some cases, like twin pregnancies or those achieved with an egg donor, we are not able to perform a fetal risk assessment.In some cases, your provider may also order carrier screening for fragile X syndrome. If you are a carrier for this, our assay cannot determine if the baby has fragile X syndrome or not. Additional testing would be recommended.
We accept ALL insurances, including Medicaid. UNITY Complete screens for recommended genetic conditions and are a covered benefit by most insurances, including Medicaid. Since each insurance plan is different, we will contact you with a text message or phone call about your out-of-pocket costs. We also offer financial assistance programs that are quick and easy. We believe every pregnant patient has the right to choose UNITY Complete without worrying about a surprise bill. If you have any questions or concerns with costs, please email us at support@unityscreen.com or call us at 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.
The type and timing of results from your UNITY Complete tests will depend on what your provider orders. Our team of genetic counselors is always happy to review your specific results if you have further questions.
Possible results with UNITY Aneuploidy NIPT typically fall into low-risk fetus or high-risk fetus results.
A Low Risk Fetus Results means that the chance your pregnancy is affected with the screened conditions is significantly reduced, but not eliminated.
Note: this result does not guarantee a healthy child and does not eliminate the possibility of other chromosome abnormalities, birth defects, or other genetic conditions.
A High-Risk Fetus Result means the chance your pregnancy is affected with a specific condition is increased. Confirmatory testing via chorionic villus sampling, amniocentesis, or postnatal evaluation is strongly recommended.
UNITY Fetal Risk Screen provides maternal carrier screening results (reported as a positive carrier or negative carrier). If a pregnant person is found to be a carrier, fetal testing will automatically be performed. Possible sgNIPT fetal results can fall into decreased/low-risk categories or increased/high-risk categories.
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 multiple genetic insights from a single maternal blood sample. The results you receive will depend on which tests your healthcare provider orders.
UNITY Aneuploidy NIPT screens pregnancies for chromosome conditions caused by extra or missing chromosomes including trisomy 21, trisomy 18, trisomy 13, monosomy X, XXX, XXY, and XYY. UNITY Aneuploidy NIPT can also tell you the baby's gender. For twin pregnancies, you will also learn if your twins are identical or fraternal.
Depending on your clinical picture, your doctor may also order UNITY Fetal RhD NIPT for moms who have a RhD- blood type, UNITY Fetal Antigen NIPT for moms who are alloimmunized to certain antigens, and 22q11.2 microdeletion analysis.
UNITY Fetal Risk Screen determines if a pregnant person is a carrier for cystic fibrosis, spinal muscular atrophy, sickle cell disease, alpha-thalassemia, or beta-thalassemia. If you're found to be a carrier for one of these conditions, the fetal DNA will be screened to determine if there is a high-chance or a low-chance for a pregnancy to be affected with a condition. In some cases, like twin pregnancies or those achieved with an egg donor, we are not able to perform a fetal risk assessment.
Your provider may also order carrier screening for fragile X syndrome. If the mom is determined to be a carrier for this, our assay can perform cell-free DNA analysis to determine if the fetus is a male- this would put the fetus at higher risk to develop Fragile X Syndrome.
We believe every pregnant patient has the right to choose UNITY Complete.
We accept ALL insurances, including Medicaid, and are in-network with the majority of insurance plans across the United States. We recognize that every patient's insurance and financial situation is unique. We have a dedicated patient services team to support patient needs, including payment plans or financial assistance for those who qualify. If you have any questions or concerns with costs, please email us at support@unityscreen.com or call us at 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.
Possible results with UNITY Aneuploidy NIPT typically fall into low-risk fetus or high-risk fetus results.
A Low Risk Fetus result means that the chance your pregnancy is affected with the screened conditions is significantly reduced, but not eliminated.
A High-Risk Fetus result means there is an increased chance for your pregnancy to be affected with a specific condition. Confirmatory testing via chorionic villus sampling, amniocentesis, or postnatal evaluation is recommended.
Note: this result does not guarantee a healthy child and does not eliminate the possibility of other chromosome abnormalities, birth defects, or other genetic conditions.
UNITY Fetal Risk Screen provides maternal carrier screening results (reported as a positive carrier or negative carrier). If a pregnant person is found to be a carrier, fetal testing will automatically be performed via cell-free DNA analysis. Possible results from the fetal testing can fall into decreased/low-risk categories or increased/high-risk categories.
Get Started.
Ready to implement a new standard in prenatal care in your practice? Order a test kit to get started.
References
1. Wynn J, et al. Performance of single-gene noninvasive prenatal testing for autosomal recessive conditions in a general population setting. Prenat Diagn. 2023 Sep; 43(10):1344-1354. doi: 10.1002/pd.6427. Epub 2023 Sep 6. PMID: 37674263
2. Carrier screening for genetic conditions. Committee Opinion No. 691.American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e41–55.
3. Practice Bulletin No. 163: Screening for Fetal Aneuploidy. Obstet Gynecol. 2016 May;127(5):e123-e137. doi: 10.1097/AOG.0000000000001406. PMID: 26938574.