Clinicians, request UNITY Screen kits.

About the Genetic Conditions

RhD & other red blood cell fetal antigens

fetal antigens C, c, D, E, Duffy (Fya), Kell (K)

Screen for the presence of fetal antigens, non-invasively, early in pregnancy

At 10+ weeks in pregnancy, UNITY Screen can look for the presence of specific fetal antigens associated with severe Hemolytic Disease of the Fetus and Newborn (HDFN) including C, c, D, E, Duffy (Fya), and Kell (K) with one blood sample from the pregnancy patient. Results do not rely or depend on obtaining a sample from the partner or undergoing invasive diagnostic testing. 

RhD is a more well known red blood cell antigen as Rho (D) immune globulin, or RhoGAM, is available as a preventative treatment to reduce the risks associated with red blood cell antigen incompatibility. There are currently no similar treatments for other red blood cell antigens. Therefore, most of these pregnancies are monitored closely during pregnancy for signs of Hemolytic Disease of the Fetus and Newborn (HDFN). 

For Rh-negative patients, UNITY can look for the presence of the fetal RhD antigen to help inform whether or not the pregnancy would benefit from RhoGAM. For alloimmunized patients, UNITY can look for C, c, D, E, Duffy (Fya) or Kell (K) to understand whether or not close monitoring is indicated. 

What is HDFN?

HDFN is caused by incompatible blood types between the pregnant patient and baby. HDFN is a rare disorder that causes red blood cells of a baby to break down too quickly during a pregnancy or shortly after delivery. This can lead to symptoms like an enlarged liver and spleen, anemia, jaundice, and additional complications. Extra monitoring and ultrasounds during pregnancy are recommended for patients at risk.

What is alloimmunization?

In addition to the main blood types (A, B, AB, and O), there are other blood groups, or “antigens” attached to red blood cells. When these antigens are present, a person is considered “antigen positive.” If antigens are not present, they are considered “antigen negative.” First pregnancies are typically not at risk for HDFN. In future pregnancies, if the pregnant patient and baby have different antigen types again, the pregnant patient’s immune system can attack the baby’s red blood cells, putting the pregnancy at risk for HDFN.

Resources

UNITY™ Carrier Screen
with Reflex Cell-Free DNA

for Common Recessive Conditions

recessive-conditions-workflow-09102021-2
Recessive conditions graph

UNITY™ sgNIPT has shown > 98.5% sensitivity and >99% specificity in a peer reviewed publication.

It has also shown 100% concordance with newborn screen results in NIH-sponsored clinical study with Baylor College of Medicine and a study with University of Alabama Birmingham.

Single-Molecule Accuracy Powered by QCT™

Using QCT™ molecular counting technology, UNITY™ is able to differentiate homozygous affected fetus (colored bars) from carrier fetus (gray bar). In addition, UNITY™ performs a paternal allele assay to detect a fetus at-risk to be compound heterozygous for CFTR or HBB at >98% detection rate.

UNITY™ Aneuploidy NIPT

UNITY™ Aneuploidy NIPT Chart

Exemplary Readout. Chromosome 21 Ratio: euploid vs trisomy 21

UNITY™ sgNIPT and Aneuploidy + RhD NIPT use synthetic molecules and computational decoding in the bioinformatics stage to reduce the assay amplification noise down to the theoretical limit. Thanks to these proprietary technologies, UNITY™ can uniquely offer reflex sgNIPT and Rh NIPT solutions.

UNITY RhD NIPT

Traditional vs UNITY Workflow for RhD NIPT

NEW! For alloimmunized patients, UNITY now screens for the presence of RBC fetal antigens associated with severe HDFN

While rare, Hemolytic Disease of the Fetus and Newborn (HDFN) can be deadly. Screening for C, c, D, E, Duffy (Fya), and Kell (K) antigens can now be added to any UNITY aneuploidy order.