RHD (gene)

Natera Reports First Quarter 2024 Financial Results

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Giovedì, Maggio 9, 2024
Biotechnology, Genetics, Health, Oncology, Nucleic acid thermodynamics, Nephrology, NTRA, Investment, RHD (gene), Uterine cancer, Research, UBS, Genetic testing, Growth, Disease, DNA, Patient, Kidney transplantation, Chronic kidney disease, Bladder cancer, Breast cancer, Pharmaceutical industry

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today reported its financial results for the first quarter ended March 31, 2024.
  • Generated total revenues of $367.7 million in the first quarter of 2024, compared to $241.8 million in the first quarter of 2023, an increase of 52.1%.
  • Generated gross margins of 56.7% in the first quarter of 2024, compared to gross margins of 38.7% in the first quarter of 2023.
  • Processed approximately 735,800 tests in the first quarter of 2024, compared to approximately 626,200 tests in the first quarter of 2023, an increase of 17.5%.

Natera Launches Fetal RhD NIPT Supporting Ob/Gyn Physicians and Patients During RhIg Shortage

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Mercoledì, Maggio 1, 2024
Health, Consumer, Women, Genetics, Baby, Maternity, Clinical Trials, Biotechnology, Fetus, Nucleic acid thermodynamics, Gamma globulin, Episcopal conference, American College, NTRA, Laboratory, RHD (gene), Anemia, Risk, Pregnancy, Blood, Northwell Health, Quality, Genetic testing, Obstetrics, DNA, SNP, ACOG, ASHG, NIPT, Patient, Human genetics, Society, Physician, Antibody, Panorama, Dietary supplement

Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test.

Key Points: 
  • Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) and genetic testing, today announced the launch of a new cfDNA-based fetal RhD test.
  • This comes at a critical time for the healthcare industry, helping physicians navigate patient care given nationwide shortages of Rho(D) immune globulin therapy (RhIg).
  • Natera’s test can be performed as early as nine weeks gestation and determines fetal RhD status from the blood of a pregnant patient, including complex pseudogene and RhD-CE-D hybrid variants.
  • The vast majority of other NIPT laboratories do not offer fetal RhD assessment, which makes it a key differentiator in addition to Natera’s core SNP-based technology.

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

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Mercoledì, Aprile 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

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Martedì, Dicembre 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

 Rallybio Announces Proof-of-Concept Results and Development Updates for RLYB212, a Novel Monoclonal anti-HPA-1a Antibody to Prevent Fetal and Neonatal Alloimmune Thrombocytopenia

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Sabato, Giugno 24, 2023
Entertainment, Health, Film & Motion Pictures, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Natural history study, PK, Red, Pregnancy, Bleeding, Half-life, RHD (gene), SC, Fetus, European Medicines Agency, Woman, Congress, Corporation, Patient, Intracranial hemorrhage, Data, Risk, Webcast, Transfusion medicine, Thrombosis, Ageing, Rare, Regulation of tobacco by the U.S. Food and Drug Administration, International Society, Food, Pharmaceutical industry, Dietary supplement, Copper, ISTH

Mean platelet elimination half-life was 5.8 hours (0.09mg) and 1.5 hours (0.29mg) for RLYB212 compared to 71.7 hours for placebo.

Key Points: 
  • Mean platelet elimination half-life was 5.8 hours (0.09mg) and 1.5 hours (0.29mg) for RLYB212 compared to 71.7 hours for placebo.
  • The study included 11 males aged 18 to 65 years, randomized to RLYB212 0.09mg (n=4), RLYB212 0.29mg (n=5), or placebo (n=2).
  • Rallybio will host an investor and analyst meeting on Saturday, June 24, 2023 from 4:00 to 6:00 p.m. Eastern Time.
  • The webcast and corresponding slides can be accessed through the Events and Presentations section of Rallybio’s website at http://www.rallybio.com .