HDFN

BILLIONTOONE MITIGATING RHOGAM(R) SHORTAGE WITH UNITY FETAL RhD™ NON-INVASIVE PRENATAL TEST

Retrieved on: 
Mittwoch, April 17, 2024
Fetus, FDA, CTA, Blood, RHD (gene), Anemia, Pregnancy, Wellstar Health System, Health care, HDFN, Placenta, Parent, Scientific Reports, Patient, Amniocentesis, Physician, Immune system, Antibody, Janssen Pharmaceuticals, Plasma, Dietary supplement

MENLO PARK, Calif., April 17, 2024 /PRNewswire/ -- BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, has reached a milestone of testing over 80,000 patients for Rh incompatibility, which develops when a pregnant patient has Rh-negative blood and the baby has Rh-positive blood. In rare cases this incompatibility can lead to a serious issue in which the pregnant patient's immune system will attack their baby's red blood cells as foreign.

Key Points: 
  • However, the FDA recently announced that the most common brand of this medication, RhoGAM(R), is in shortage .
  • Utilizing cell-free DNA in maternal plasma, the UNITY Fetal RhD Non-Invasive Prenatal Test can determine fetal RhD status," said Jennifer Hoskovec, MS, Certified Genetic Counselor and Senior Director of Medical Affairs at BillionToOne.
  • The UNITY Fetal RhD NIPT offers a reliable and convenient alternative to traditional methods of determining fetal RhD status, such as paternal testing and invasive procedures like amniocentesis.
  • The UNITY Fetal RhD NIPT accurately determines the RhD status of the fetus from maternal blood as early as 10 weeks gestation.

BillionToOne Announces Global Collaboration to Provide its UNITY Fetal Antigen™ Clinical Trial Assay in Johnson & Johnson Phase 3 Clinical Trial of Nipocalimab in Hemolytic Disease of the Fetus and Newborn

Retrieved on: 
Dienstag, Dezember 12, 2023
QCT, Food and Drug Administration, AZALEA, Johnson & Johnson, DNA, Food, Risk, Clinical trial, RBC, European, Anemia, LDT, FDA, Blood, IDE, Janssen Pharmaceuticals, Prenatal testing, Doctor of Philosophy, NGS, HDFN, Investigational device exemption, Kell, Fetus, Viscosity, RHD (gene), Vaccine

MENLO PARK, Calif., Dec. 12, 2023 /PRNewswire/ -- BillionToOne (BTO), a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is pleased to announce a global collaboration with Janssen Research & Development, LLC, a Johnson & Johnson company (Johnson & Johnson), in the AZALEA Phase 3 clinical trial of nipocalimab in pregnancies at risk for severe hemolytic disease of the fetus and newborn (HDFN). BTO will provide its UNITY Fetal Antigen Non-invasive Prenatal Test Clinical Trial Assay (UNITY Fetal Antigen CTA), which will serve as a screening assay to help determine the eligibility of pregnant individuals to be included in the trial, which will be conducted in the United States, the European Union, and other select countries in the rest of the world. HDFN is a serious and rare condition which occurs when the blood types of a pregnant individual and the fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.1

Key Points: 
  • "The ability to detect fetal antigens as early as 10 weeks is only made possible due to our expertise in fetal DNA quantification.
  • The UNITY Fetal Antigen CTA is just one of the many applications of our QCT technology's capabilities."
  • Earlier this year, BillionToOne also published clinical validation data of the UNITY Fetal Antigen Laboratory Developed Test (LDT)2.
  • Additionally, the UNITY Fetal Antigen LDT results were 100% concordant with corresponding neonatal antigen genotype/serology for 23 RhD-negative pregnant individuals and 93 antigen evaluations in 30 alloimmunized pregnancies.2

New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)

Retrieved on: 
Montag, Juni 26, 2023
EOS, HDFN, Fetus, Umbilical cord, European Medicines Agency, Janssen, Janssen Pharmaceuticals, Patient, Memorial Hermann–Texas Medical Center, Risk, Immunoglobulin G, Disease, Infant, IUT, Neonatal Fc receptor, UNITY, Tissue, Ohio State University, Hydrops, University, Dell Medical School, Gestational age, EMA, SPRING, Diagnosis, FDA, FC, Placenta, HOUSE, Health, Maternal–fetal medicine, Child, Șaeș, Blood, Immune system, Mortality, Johnson & Johnson, Epidural hematoma, Anemia, Infection, Edema, Clinical trial, Fast Track, Mount Sinai Hospital, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Birth control, Dietary supplement

SPRING HOUSE, Pa., June 26, 2023 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY clinical trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) hemolytic disease of the fetus and newborn (HDFN).1 A statistically significant (54 percent [n=7/13]) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational age of 32 weeks without intrauterine transfusions (IUTs)1,a compared to the historic reference point of 10 percent, which was derived from published and unpublished data.2-5,b Among the seven participants who achieved the primary endpoint, the median gestational age at delivery was 37 and 1/7 weeks.6 This study demonstrates the potential for nipocalimab to help address the underlying disease mechanism of EOS HDFN.1 If approved, nipocalimab would be the first anti-neonatal Fc receptor (FcRn) treatment and the first approved non-surgical intervention for pregnancies at high risk of HDFN in the U.S.7 These data will be presented for the first time at the Fetal Medicine Foundation World Congress in Valencia, Spain on June 26, 2023.1 Janssen is planning a pivotal Phase 3 trial for nipocalimab in pregnancies at risk for severe HDFN.

Key Points: 
  • "There is a significant unmet need to help address the serious and life-threatening health consequences of HDFN.
  • "These Phase 2 UNITY data in high-risk pregnancies demonstrated the important role that nipocalimab, an FcRn blocking antibody, may play in preventing the transfer of maternal alloantibodies through the placenta, thereby offering a potential treatment option for this devastating disease."
  • A conservative benchmark of 10 percent of patients not requiring an IUT was chosen to account for uncertainties in the accuracy and representation of the underlying data.2
    d.  Dr. Kenneth Moise is a paid consultant for Janssen.
  • He has not been compensated for any media work.

Rallybio Announces Publication of Data Highlighting the Ability of HPA-1a-Specific Antibodies to Prevent Alloimmunization in an Authentic Mouse Model of FNAIT

Retrieved on: 
Donnerstag, Dezember 15, 2022
Research, Finance, Clinical Trials, Professional Services, Biotechnology, Health, Pharmaceutical, General Health, Science, Editorial, Biotechnology, HDFN, Female, Corporation, Pregnancy, Society, Partnership, Hematology, Patient, Macrocytic anemia, Degenerative disease, Research, Disease, Zhi, Incidence, Transfusion medicine, Antibody, Placenta, University, Fetus, Risk, Vaccine, Pharmaceutical industry, Blood

Rallybio Corporation (Nasdaq: RLYB) today announced publication of preclinical study results for two human HPA-1a-specific antibodies in development for the prevention of FNAIT.

Key Points: 
  • Rallybio Corporation (Nasdaq: RLYB) today announced publication of preclinical study results for two human HPA-1a-specific antibodies in development for the prevention of FNAIT.
  • These results also establish the concentration-effect relationship and threshold exposure targets for effective prophylactic treatment with HPA-1a specific antibodies to prevent FNAIT.
  • FNAIT is a rare, life-threatening bleeding disorder where maternal alloantibodies cross the placenta and lead to depletion of fetal platelets.
  • provide proof-of-concept that prophylactic administration of HPA-1a-specific antibodies could be similarly effective at preventing anti-HPA-1a alloimmunization in pregnant women at risk for FNAIT.

BillionToOne Launches Novel Fetal Antigen NIPT as Part of UNITY Screen™ to Help Streamline Management of Pregnant Patients Who Are Alloimmunized

Retrieved on: 
Freitag, September 30, 2022
QCT (Quanta Cloud Technology), Risk, Kell, Fetus, RBC, NIPT, Antibody, Company, Macrocytic anemia, UNITY, Bilirubin, Risk assessment, Patient, Pregnancy, Technology, Moses Austin, Dell Medical School, HDFN, Anxiety, PMID, Manuscript, Death, DNA, QCT, Multimedia, Health, University, Placenta, Anemia, Vaccine, Medical imaging

This novel fetal antigen NIPT may help streamline management of most alloimmunized pregnant patients.

Key Points: 
  • This novel fetal antigen NIPT may help streamline management of most alloimmunized pregnant patients.
  • The UNITY fetal antigen NIPT report will show if the fetal antigen of interest is detected or not detected, providing stronger clinical conviction for those patients who require rigorous monitoring.
  • Oguzhan Atay, BillionToOne CEO, added, "We are thrilled to launch our UNITY fetal antigen sgNIPT.
  • The UNITY fetal antigen NIPT is available now for order by any provider managing pregnant patients who are alloimmunized.