Rh factor

The UNITY Fetal Antigen Clinical Trial Assay has received Investigational Device Exemption (IDE) as part of this initiative 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 "We are extremely proud to play a critical role in this clinical trial with the UNITY Fetal Antigen CTA test" said Oguzhan Atay, PhD, CEO of BillionToOne. "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." In April 2023 U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE), to enable the UNITY Fetal Antigen CTA to be used in this trial, an important milestone to support the start of the Phase 3 AZALEA study of nipocalimab in HDFN in the U.S. BillionToOne will also seek regulatory clearance by health authorities around the world for the UNITY Fetal Antigen CTA. The UNITY Fetal Antigen CTA is a next-generation sequencing (NGS) non-invasive prenatal test intended for the qualitative detection of cell-free fetal DNA (cffDNA) encoding for fetal antigens RhD, RhC, Rhc, RhE, or Kell (K) in the blood of pregnant adults who are alloimmunized against the corresponding fetal red blood cell (RBC) antigen and at risk of HDFN. Earlier this year, BillionToOne also published clinical validation data of the UNITY Fetal Antigen Laboratory Developed Test (LDT)2. In this validation study, the UNITY Fetal Antigen LDT correctly determined the antigen status for 1,061 preclinical samples resulting in >99.9% concordance and a sensitivity and specificity of >99.9% (95% CI: 99-100%). 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 About Hemolytic Disease of the Fetus and Newborn (HDFN) HDFN is a serious condition that occurs when a pregnant patient's antibodies cross the placenta and attack the fetal red blood cells.1 When most severe, HDFN can cause life-threatening anemia in the fetus.3 There are currently no approved non-surgical interventions for pregnancies at high risk of HDFN.4 Pregnancies affected by severe HDFN may necessitate repeated intrauterine transfusions (IUTs), an invasive, technically complex surgical procedures performed by specialists at specialized medical centers, and these procedures may be associated with an increased rate of fetal mortality and premature births.4,5,6 About the UNITY Fetal Antigen CTA The UNITY Fetal Antigen CTA was developed to support the AZALEA study in the phase 3 clinical trial of nipocalimab in HDFN. In April 2023 U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE), to enable the UNITY Fetal Antigen CTA to be used in this trial. The UNITY Fetal Antigen CTA is a next-generation sequencing (NGS) non-invasive prenatal test intended for the qualitative detection of cell-free fetal DNA (cffDNA) encoding for fetal antigens RhD, RhC, Rhc, RhE, or Kell (K) in the blood of pregnant adults who are alloimmunized against the corresponding fetal red blood cell (RBC) antigen and at risk of HDFN. The UNITY Fetal Antigen CTA has not been cleared by the FDA for commercial use. About the UNITY Fetal Antigen LDT UNITY Fetal Antigen LDT was first made available in September 2022 for pregnant patients alloimmunized against RhD, C, c, E, K (Kell), and Fya (Duffy) red blood cell (RBC) antigens. Using BillionToOne's proprietary molecular counting technology or Quantitative Counting Templates™, this NGS-based assay detects the presence or absence of the genetic variants that code for corresponding fetal antigens to accurately identify which patients are truly at highest risk for developing HDFN. Since the test was made available, more than 1,300 UNITY Fetal Antigen NIPTs have been ordered in a commercial setting. About 60% of those patients received a "Not Detected" Fetal Antigen result, potentially sparing the expecting families from follow-ups and undue anxiety2. The UNITY Fetal Antigen LDT is available for clinical use through BillionToOne's CLIA-certified and CAP-accredited clinical laboratory. About BillionToOne Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for everyone. The company's patented Quantitative Counting Technology™ (QCT™) molecular counting platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, please visit For more information about the trial or the collaboration, please contact [[email protected]] SOURCE BillionToOne

In a clinical validation study published on Scientific Reports, UNITY RhD NIPT and Fetal antigen NIPT demonstrated 100% sensitivity, 100% specificity, 99.9% precision with 0.1% no-call rate across 3,921 NIPT assays. MENLO PARK, CA / ACCESSWIRE / August 11, 2023 / BillionToOne, experts in fetal DNA quantification, announced today that Scientific Reports published a study1 of the UNITY Fetal Antigen Noninvasive Prenatal Test (NIPT). The validation study marks an inflection point for patients who are at risk of Hemolytic Disease of the Fetus and Newborn (HDFN) due to the assay's unmatched accuracy coupled with its novel approach. Validation of a non-invasive prenatal test for fetal RhD, C, c, E, K and Fya antigens In this validation study co-authored by scientists at BillionToOne and Brigham and Women's Hospital and senior-authored by Dr. Kathryn Gray, MD, PhD, the UNITY Fetal Antigen NIPT correctly determined the antigen status for 1,061 preclinical samples resulting in 100% sensitivity and specificity and achieved 99.9% precision on 1,683 clinical samples. Clinical samples with known outcomes (neonatal antigen genotype/serology) were also evaluated with 100% concordance across 93 antigen evaluations in 30 alloimmunized pregnancies. Impressively, 100% accuracy was achieved while maintaining a low no-call rate of 0.1%. HDFN is a serious condition that occurs when a pregnant patient's antibodies cross the placenta and attack the fetal red blood cells. When most severe, HDFN can cause life-threatening anemia in the fetus. Prior to the availability of UNITY Fetal Antigen NIPT, identifying patients at highest risk of HDFN was error-prone and cumbersome, necessitating a partner's sample and invasive diagnostic testing. This new approach with UNITY Fetal Antigen NIPT is set to revolutionize identification and management for patients at risk of severe HDFN due to the assay's greater accuracy and convenience compared to existing tests like amniocentesis, which comes with many risks, particularly for patients at risk of HDFN. The publication also highlights how UNITY Fetal Antigen NIPT can also be used to nearly eliminate unnecessary prophylactic treatment for 40% of RhD-negative pregnancies. The assay's unique capability to accurately assess non-deletion RHD gene variants, which are more prevalent in non-European populations, underscores the test's applicability and validity across ethnically diverse populations. This capability reduces the assay no-call rate to 0.1%, significantly lower than any previous RhD assays and addresses any potential concerns against front-line RhD NIPT screening. "At BillionToOne, we are uniquely positioned to do the unthinkable with genetic testing due to our QCT technology," said Oguzhan Atay, PhD, CEO of BillionToOne. "The published validation data for UNITY Fetal Antigen NIPT is a perfect example of this, ultimately setting a new standard for patients and providers in the management of HDFN." As stated in the publication, "the clinical implementation of NIPT can significantly improve the standard of care for both prevention of RhD alloimmunization and management of alloimmunization in pregnancy." About the UNITY Fetal Antigen NIPT The UNITY Fetal Antigen Test Screen was first launched in September 2022 for pregnant patients alloimmunized against RhD, C, c, E, K (Kell), and Fya (Duffy) red blood cell (RBC) antigens, and can be performed as early as 10 weeks of gestation. Using BillionToOne's proprietary molecular counting technology or Quantitative Counting TemplatesTM (QCTs), this NGS-based assay detects the presence or absence of the genetic variants that code for corresponding fetal antigens to accurately identify which patients are truly at highest risk for developing HDFN. Since its launch, over 1,000 UNITY Fetal Antigen NIPT have been ordered for clinical use. About 60% of those patients received a "Not Detected" Fetal Antigen result, sparing the expecting parents from unnecessary follow-ups and undue anxiety. About UNITY Fetal RhD NIPT The UNITY RhD NIPT was launched in 2020 for pregnant patients with RhD-negative blood type at the gestational age of 10 weeks or higher. Up to 40% of RhD-negative pregnant individuals carry an RhD-negative fetus and do not need the administration of Rho(D) immune globulin. The QCT technology-based quantitative approach with NGS enables the assay to detect fetal RhD status both for the common RHD gene deletion and other RHD variants such as RHDΨ, significantly reducing the no-call rate while maintaining 100% sensitivity and specificity. About BillionToOne Headquartered in Menlo Park, California, BillionToOne is a precision diagnostics company on a mission to make molecular diagnostics more accurate, efficient, and accessible for everyone. The company's patented QCT™ molecular counter platform is the only multiplex technology that can accurately count DNA molecules at the single-molecule level. For more information, please visit . For more information about the trial or the collaboration, please contact media@billiontoone.com. 1 Alford, B., Landry, B.P., Hou, S. et al. Validation of a non-invasive prenatal test for fetal RhD, C, c, E, K and Fya antigens. Sci Rep 13, 12786 (2023). Contact Information Courtnay Davis Events Marketing Manager media@billiontoone.com 6504602551 SOURCE: BillionToOne Inc. View source version on accesswire.com:

STOCKHOLM, May 11, 2023 /PRNewswire/ -- Devyser is today announcing that its product for non-invasive fetal RHD testing has been granted regulatory approval in Canada. Devyser already has a contract with Canada's Héma-Québec to deliver RHD tests. The product approval by Health Canada means that it meets the established safety, efficacy and quality requirements for products marketed and sold in Canada. Devyser has had MDSAP approval for the quality management system since 2020, which is a requirement for product registration in Canada. The RHD test is Devyser's first approved Class III IVD product in Canada. "Approval is needed so that we can deliver on our contract with Héma-Québec, which is an important part of our investment in the North American market. Héma-Québec will shortly launch tests to verify and validate the product, and then start placing orders. Approval for registration will hopefully pave the way for increased sales of RHD tests in Canada", says Fredrik Alpsten, CEO at Devyser. The regulatory approval application was submitted as part of the procurement process connected with the company's 2022 contract with Héma-Québec, an exclusive supplier of blood products in the Quebec region. The contract will initially run for three years, and may potentially be extended for another two years. The total potential order value amounts to just over SEK 16 million. Devyser's RHD product is used by diagnostic laboratories for the non-invasive determination of the RHD status of fetuses from maternal blood samples. It is important to determine the RHD status of fetuses for pregnant women who are RHD negative to avoid hemolytic disease, a condition that can be life-threatening for newborns. Hemolytic disease can be prevented through the early determination of fetal RHD status and prophylactic treatment during pregnancy. The information was submitted for publication, through the agency of the contact persons below, on May 11, 2023 at 16:15 CET. For more information, please contact: Fredrik Alpsten, CEO Email: [email protected] Telephone: +46 70 667 31 06 Sabina Berlin, CFO Email: [email protected] Telephone: +46 73 598 07 76 About Devyser Devyser develops, manufactures and sells diagnostic solutions and analysis services to clinical laboratories in more than 50 countries. Our products are used for complex genetic testing in the hereditary disease, oncology and transplant fields, to enable targeted cancer treatment, the diagnosis of a large number of genetic diseases, and transplant patient follow-up. Devyser's products, and unique, patented solution requiring only one test tube, simplify genetic testing processes, improve sample throughput, minimize hands-on time and deliver rapid results. Our goal is for every patient to receive a correct diagnosis in the shortest possible time. Devyser was founded in 2004 and is based in Stockholm, Sweden. The company has eight in-house sales offices in Europe and the US, and a CLIA laboratory in Atlanta, Georgia. In August 2022, Devyser's quality management system and Devyser Compact were certified according to the IVDR. Devyser's shares are listed on the Nasdaq First North Premier Growth Market Stockholm (ticker: DVYSR). The company's Certified Adviser is Redeye AB. For more information, visit . SOURCE Devyser Diagnostics AB