First-of-its-kind fetal RhD prenatal testing
Unity Fetal RhD™ NIPT is a non-invasive test that assesses a baby's fetal RhD status, as early as 9 weeks.
Know early with one simple blood test.
Unity Complete® screens for common and severe genetic conditions (PLUS fetal antigens for specific patients) all from a single maternal blood sample, no partner testing needed. Results are delivered in about two weeks.
Unity Fetal RhD™ NIPT is a non-invasive test that assesses fetal RhD status (available in the U.S.) and may prevent unnecessary intervention for ~40%* of RhD- pregnant patients. This helps to clarify which patients may benefit from Rho(D) Immune Globulin Human (RhoGAM).
*Practice Bulletin No. 181: Prevention of Rh D Alloimmunization. Obstetrics & Gynecology 130(2):p e57-e70, August 2017. | DOI: 10.1097/AOG.0000000000002232
RhD-Negative Antigen Detection & Treatment
- Unity Fetal RhD™ NIPT offers a reliable and convenient alternative to traditional methods of determining fetal RhD status, accurately determining the RhD status of the fetus from maternal blood as early as 9 weeks gestation.
- Results can help indicate which patients will benefit from RhoGAM and prevent unnecessary intervention for 40% of RhD- pregnant patients
- 100% concordance to neonatal outcomes and >99.9% sensitivity and specificity in detecting fetal D antigen. Read the full publication in Nature's Scientific Report
Unity Complete.
Unity Complete is the only prenatal test that goes from screening to confirmation.
Unity Complete screens for recessive and chromosomal conditions aligned with ACOG screening recommendations.* Patients who are RhD-negative or alloimmunized may also benefit from Unity Fetal Antigen™ tests, which can be added to Unity Aneuploidy™ NIPT at any point during pregnancy.
Unity Fetal RiskTM Screen
- Cystic Fibrosis‡
- Sickle Cell Disease
- Beta-Thalassemia
- Spinal Muscular Atrophy
- Alpha-Thalassemia
- 5-Gene Panel
- Canavan Disease
- MCAD Deficiency
- Tay-Sachs Disease
- Familial Dysautonomia
- Smith-Lemli-Opitz Syndrome
- PMM2-Congenital Disorder of Glycosylation
- DMD-Associated Dystrophinopathies*
- Phenylalanine Hydroxylase Deficiency (PKU)
- Fragile X Syndrome*† (optional)
Unity AneuploidyTM NIPT
- Trisomy 21*
- Trisomy 18*
- Trisomy 13*
- Sex Chromosome Aneuploidies:
X, XXY, XYY, XXX - Zygosity (included for twins)
- 22q11.2 Microdeletion Syndrome (optional)*
- Fetal Sex (optional)*
Unity Fetal AntigenTM Tests
- Big C, little c, D, E, e, Fya (Duffy), Fyb (Duffy), jka (Kidd), jkb (Kidd), K (Kell), k, M, N, Big S, little s, U
- *M and N antigens must be selected at ordering and cannot be added after the test is submitted
- HPA-1a (with HLA-DRB3*01:01 when applicable), HPA-1b, HPA-2a, HPA-2b, HPA-3a, HPA-3b, HPA-4a, HPA-4b, HPA-5a, HPA-5b, HPA-9a, HPA-9b, HPA-15a, HPA-15b
Unity ConfirmTM
Non-invasive confirmatory testing for patients who receive high-risk Unity Aneuploidy NIPT results.*
Powered by Fetal Cell Capture™ technology, Unity Confirm uses whole genome sequencing of intact circulating fetal cells.
Only with Unity Aneuploidy NIPT
Access a Sample Report.
The Latest Data With Unity Complete.
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Additional Provider Resources.
Unity Complete Brochure
Test Requisition Form
Unity Confirm Brochure
Carrier Frequencies
MFM Perspective
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™ NIPT 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 NIPT 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.
Received a high-risk result? Speak with your healthcare provider to find out if Unity Confirm — a non-invasive blood test that can provide important information to help guide your care — is right for your pregnancy.
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.
References
Carrier screening for genetic conditions. Committee Opinion No. 691.American College of Obstetricians and Gynecologists. Obstet Gynecol 2017;129:e41–55.
Practice Bulletin No. 163: Screening for Fetal Aneuploidy. Obstet Gynecol. 2016 May;127(5):e123-e137. doi: 10.1097/AOG.0000000000001406. PMID: 26938574.
Unity tests can produce false-positive and false-negative results. Results are not a guarantee. Amniocentesis should always be considered with high risk results. Important medical decisions should not rely on Unity test results alone. Clinical correlation is necessary, including but not limited to the results of prior and further prenatal testing. Unity tests are laboratory-developed tests performed in a CLIA-certified and CAP-accredited laboratory. They are not FDA-approved or FDA-cleared diagnostic tests. Test performance may vary based on gestational age and other factors.