The UNITY Fetal Antigen Clinical Trial Assay has received Investigational Device Exemption (IDE) as part of this initiative

作为这项举措的一部分，UNITY胎儿抗原临床试验检测已获得研究设备豁免（IDE）

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).

加利福尼亚州门洛帕克，2023年12月12日/PRNewswire/--十亿通（BTO），一家分子诊断公司，其使命是创建强大而准确的测试，所有人都可以使用，很高兴宣布与强生公司（Johnson＆Johnson）Janssen Research＆Development，LLC进行全球合作，在nipocalimab的杜鹃花3期临床试验中，有胎儿和新生儿严重溶血病（HDFN）风险的孕妇。

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.

BTO将提供其UNITY胎儿抗原非侵入性产前检测临床试验检测（UNITY胎儿抗原CTA），该检测将作为筛查检测，以帮助确定怀孕个体是否符合纳入试验的资格，该试验将在美国，欧盟和世界其他国家进行。

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.

HDFN是一种严重而罕见的疾病，当孕妇和胎儿的血型不相容时，可能会导致胎儿或婴儿致命的贫血。

'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.'.

BillionToOne首席执行官Oguzhan Atay博士说：“我们非常自豪能够在联合胎儿抗原CTA检测的临床试验中发挥关键作用。”由于我们在胎儿DNA定量方面的专业知识，最早在10周内检测胎儿抗原的能力才成为可能。UNITY胎儿抗原CTA只是我们QCT技术功能的众多应用之一。”。

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..

2023年4月，美国食品和药物管理局（FDA）批准了一项研究设备豁免（IDE），以使UNITY胎儿抗原CTA能够用于该试验，这是支持美国HDFN中nipocalimab的3期杜鹃花研究开始的一个重要里程碑。十亿通还将寻求世界各地卫生当局对UNITY胎儿抗原CTA的监管许可。。

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..

UNITY胎儿抗原CTA是一种下一代测序（NGS）非侵入性产前检测，旨在定性检测编码胎儿抗原RhD，RhC，RhC，RhE或Kell（K）的无细胞胎儿DNA（cffDNA），这些胎儿抗原是针对相应的胎儿红细胞（RBC）抗原进行同种免疫并有HDFN风险的孕妇血液中的。。

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%).

今年早些时候，BillionToOne还发布了UNITY胎儿抗原实验室开发的测试（LDT）2的临床验证数据。在这项验证研究中，统一胎儿抗原LDT正确地确定了1061个临床前样本的抗原状态，导致>99.9%的一致性和>99.9%的敏感性和特异性（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.

此外，23例RhD阴性孕妇的统一胎儿抗原LDT结果与相应的新生儿抗原基因型/血清学结果100%一致，30例同种免疫妊娠的93例抗原评估结果一致。

About Hemolytic Disease of the Fetus and Newborn (HDFN)

关于胎儿和新生儿溶血病（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.

HDFN是一种严重的疾病，当孕妇的抗体穿过胎盘并攻击胎儿红细胞时就会发生。1最严重时，HDFN会导致胎儿致命的贫血。3目前尚无批准的非手术干预措施用于HDFN高危妊娠。4受严重HDFN影响的妊娠可能需要重复宫内输血（IUT），由专业医疗中心的专家进行的侵入性，技术复杂的外科手术，这些手术可能与胎儿死亡率和早产率增加有关[4,5,6]。

About the UNITY Fetal Antigen CTA

关于统一胎儿抗原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.

UNITY胎儿抗原CTA的开发是为了支持nipocalimab在HDFN中的3期临床试验中的杜鹃花研究。2023年4月，美国食品和药物管理局（FDA）批准了一项研究设备豁免（IDE），以使UNITY胎儿抗原CTA能够用于该试验。UNITY胎儿抗原CTA是一种下一代测序（NGS）非侵入性产前检测，旨在定性检测编码胎儿抗原RhD，RhC，RhC，RhE或Kell（K）的无细胞胎儿DNA（cffDNA），这些胎儿抗原是针对相应的胎儿红细胞（RBC）抗原进行同种免疫并有HDFN风险的孕妇血液中的。

The UNITY Fetal Antigen CTA has not been cleared by the FDA for commercial use..

统一胎儿抗原CTA尚未被FDA批准用于商业用途。。

About the UNITY Fetal Antigen LDT

关于统一胎儿抗原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.

联合胎儿抗原LDT于2022年9月首次用于针对RhD，C，C，E，K（Kell）和Fya（Duffy）红细胞（RBC）抗原同种免疫的孕妇。使用亿万通专有的分子计数技术或定量计数模板™,这种基于NGS的检测方法检测是否存在编码相应胎儿抗原的遗传变异，以准确识别哪些患者真正处于发展HDFN的最高风险。

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..

自从该测试可用以来，已经在商业环境中订购了1300多种统一胎儿抗原NIPT。这些患者中约有60%接受了“未检测到”的胎儿抗原结果，这可能使预期的家庭免于随访和过度焦虑2。UNITY胎儿抗原LDT可通过BillionToOne的CLIA认证和CAP认证的临床实验室进行临床使用。。

About BillionToOne

关于十亿元

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..

BillionToOne总部位于加利福尼亚州门洛帕克，是一家精密诊断公司，其使命是使分子诊断更加准确，高效，人人都可以使用。该公司的专利定量计数技术™（QCT™)分子计数平台是唯一可以在单分子水平上准确计数DNA分子的多重技术。。

For more information, please visit www.billiontoone.com

欲了解更多信息，请访问www.billiontoone.com

For more information about the trial or the collaboration, please contact [[email protected]]

有关试用或合作的更多信息，请联系[[受电子邮件保护]]

SOURCE BillionToOne

来源：Billiontoone