Rheumatic Fever

ACOG supports cfDNA testing as a reasonable alternative for fetal RBC testing among alloimmunized patients MENLO PARK, Calif., July 26, 2024 /PRNewswire/ -- BillionToOne, a molecular diagnostics company with a mission to create powerful and accurate tests that are accessible to all, is thrilled to announce a new publication that shows cfDNA analysis is highly sensitive and specific for determining fetal antigen genotype as early as 10 weeks gestation. The new study published online in Obstetrics and Gynecology, the official journal of the American College of Obstetricians and Gynecologists (ACOG), also known as "The Green Journal," supports the implementation of cfDNA testing to manage alloimmunized pregnancies in the United States. This study follows the recent ACOG clinical practice update that supports cfDNA testing as a reasonable alternative to amniocentesis for fetal RBC testing among alloimmunized patients. Hemolytic disease of the fetus or newborn (HDFN) is a potentially life-threatening form of anemia caused by alloimmunization. ACOG recommends testing the reproductive partner's antigen status when alloimmunization is diagnosed in pregnancy. However, rates of reproductive partner screening uptake are low, and results can be misleading in the setting of nonpaternity. In September 2022, BillionToOne's UNITY Fetal Antigen NIPT became the first commercially available cfDNA test in the US, providing highly accurate assessments of the fetal status for RhD, c, C, E, K and Fya antigens. It is the only clinically available NIPT in the US that includes antigens beyond RhD and is offered as an add on to UNITY Complete, the first and only test that uses cell-free DNA to provide precise fetal insights for both recessive and chromosomal conditions. The Green Journal study demonstrates the accuracy of an NGS-based cfDNA analysis assay using BillionToOne's proprietary Quantitative Counting Templates™ (QCT™) for the detection of fetal red blood cell antigen status in a large, diverse U.S.-based cohort. With 100% accuracy and no need for paternal testing or invasive procedures, the study finds that this assay will result in more alloimmunized individuals receiving informative results about fetal risk when compared to the traditional approach. "We commend ACOG for acknowledging the role of NIPT for fetal red blood cell antigen genotyping and are thrilled that this new study highlights the UNITY Fetal Antigen NIPT screen's accuracy across all gestational ages and ethnicities, including complex maternal and fetal genotypes," said Jennifer Hoskovec, Certified Genetic Counselor and Vice President of Medical Affairs at BillionToOne. "The implications of this ACOG update are significant for patients and providers alike, reducing the need for resource intensive pregnancy surveillance for fetal anemia for many patients." ACOG also recently announced that the use of RhD NIPT to conserve supply of Rh immunoglobulin (RhIg), also known as RhoGAM, is a reasonable consideration in the practice setting that is experiencing RhIg shortages. Since becoming available in 2020, BillionToOne's Fetal RhD NIPT has served over 100,000 patients. The test offers a reliable and convenient alternative to traditional methods of determining fetal RhD status via cell-free DNA from maternal blood only as early as 9 weeks gestation. 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 all. The company's patented Quantitative Counting Templates™ (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 . Media Contact: [email protected] SOURCE BillionToOne

FRIDAY, June 7, 2024 -- Mortality related to rheumatic heart disease (RHD) is high and is correlated with the severity of valve disease, according to a study published online June 5 in the Journal of the American Medical Association. Ganesan Karthikeyan, D.M., from the All India Institute of Medical Sciences in New Delhi, and colleagues assessed the risk and predictors of major patient-important clinical outcomes in patients with clinical RHD. Analysis included 13,696 patients in 24 low- and middle-income countries. The researchers found that over a median duration of 3.2 years, 15 percent of patients died overall (4.7 percent per patient-year). Vascular causes accounted for most deaths (67.5 percent), mainly heart failure or sudden cardiac death. Both stroke (0.6 percent per year) and recurrent rheumatic fever was rare. Higher mortality was seen with markers of severe valve disease, including congestive heart failure (hazard ratio [HR], 1.58), pulmonary hypertension (HR, 1.52), and atrial fibrillation (HR, 1.30). Lower mortality was seen with surgical treatment (HR, 0.23) or valvuloplasty (HR, 0.24). Lower mortality was also seen with higher country income level, when adjusting for patient-level factors. "Study findings suggest a greater need to improve access to surgical and interventional care, in addition to the current approaches focused on antibiotic prophylaxis and anticoagulation," the authors write. Several authors disclosed ties to pharmaceutical companies, including Bayer, which funded the study.

Eli Lilly has announced a further commitment of $6.5m to the US Fund for UNICEF during the World Health Assembly (27 May to 1 June 2024) in Geneva to expand UNICEF’s work to improve the health outcomes of children and adolescents at risk of noncommunicable diseases (NCDs) in India. The new funding builds on Lilly’s initial commitment of $14.4m, announced in 2022, bringing the company’s total commitment to more than $20m. In alignment with Lilly’s 30×30 initiative to improve access to quality health care for 30 million people living in resource-limited settings annually by 2030, the collaboration with UNICEF aims to help ten million children and adolescents living with chronic NCDs through 2025 by addressing NCD risk factors, strengthening health systems and enhancing the ability of healthcare workers to care for patients in Bangladesh, Malawi, Nepal, the Philippines, Zimbabwe, and now in health resource-limited settings in India. The burden of NCDs is disproportionately felt by low-income countries, communities and the most vulnerable people, such as children and adolescents. In 2019, NCDs accounted for 66% of all deaths in India, 22% of which were premature, according to the World Health Organization NCD database. In addition, 70% of preventable adult deaths in India from NCDs are linked to risk factors that start in adolescence. The additional funding will support UNICEF when supporting millions of children and their families with diseases such as type 1 diabetes, respiratory illnesses, rheumatic and congenital heart disease and sickle cell disease. Luigi D’Aquino, chief of health, UNICEF India, commented: “UNICEF will work with governments and partners to strengthen health systems to effectively manage NCDs in children and young people” and “help integrate efforts into maternal, newborn and child health programmes, emphasising prevention and management of childhood NCDs”. Cynthia Cardona, head of social impact, Lilly, commented: “These efforts are critical to working towards changing the global landscape of NCDs and improving health outcomes for children and adolescents living in resource-limited areas in India.” Since announcing the collaboration in 2022, UNICEF has screened hundreds of children for NCDs, trained over 2,000 health workers and reached more than 350,000 families with awareness messages on NCD prevention.