Sera Prognostics Announces Publication Of Data Confirming The Performance Of The IBP4/SHBG Biomarkers In Diverse Non-U.S. Populations
Sera Prognostics Announces Publication Of Data Confirming The Performance Of The IBP4/SHBG Biomarkers In Diverse Non-U.S. Populations
SALT LAKE CITY, Dec. 1, 2021 /PRNewswire/ -- Sera Prognostics Inc., The Pregnancy Company® (NASDAQ: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the publication of a study funded by the Bill & Melinda Gates Foundation and in collaboration with AMANHI (Alliance for Maternal and Newborn Health Improvement), a multinational effort to improve health for pregnant and postpartum women and their babies in sub-Saharan Africa and South Asia. The newly published article presents the performance of the IBP4/SHBG biomarker pair in predicting spontaneous preterm birth (sPTB) in low and middle income geographies, with prespecified adjustment for demographic differences between the populations.
"Sera is committed to addressing the global challenges of premature births," said Gregory C. Critchfield, MD, MS, Chairman and CEO of Sera Prognostics. "The data published today demonstrate that our biomarkers can be used to predict sPTB in patient populations with baseline demographics and health care access that are distinct from those of U.S. populations in which they were initially validated. We believe that these data warrant careful consideration by all stakeholders who seek to improve maternal and neonatal outcomes and support the further evaluation of these biomarkers in additional populations."
The PreTRM® test was developed and validated for prediction of spontaneous preterm birth (sPTB) broadly in the U.S. in the Proteomic Assessment of Preterm Risk (PAPR) study. The biomarkers were subsequently shown to be predictive of very early preterm birth of any cause, length of neonatal hospital stay, and neonatal morbidity and mortality in a second large prospective U.S. study, the Multicenter Assessment of a Spontaneous Preterm Birth Risk Predictor (TREETOP) study. Now, analysis of biomarker performance in AMANHI samples, published in the peer-reviewed Journal of Maternal-Fetal & Neonatal Medicine in an article entitled "Performance of a validated spontaneous preterm delivery predictor in South Asian and sub-Saharan African women: a nested case-control study": https://www.tandfonline.com/doi/full/10.1080/14767058.2021.2005573 demonstrates confirmation of PreTRM biomarker predictive performance for prematurity with prespecified adjustment for expected demographic differences in populations outside of the United States.
The AMANHI biobanking study enrolled 10,001 pregnant women in Bangladesh, Pakistan, and Tanzania from whom a nested case control analysis was conducted in 298 representative pregnancies. This work demonstrated that IBP4 and SHBG, the biomarkers utilized by the U.S. PreTRM® test, after prespecified adjustment for expected demographic differences between the populations, significantly predicted sPTB. As was demonstrated in the U.S. studies, the biomarkers performed well for prediction of sPTB <37 weeks and for earlier more severe preterm births. The new publication further demonstrates the strength of Sera's artificial intelligence pipeline by the identification of a limited number of additional biomarkers that complement IBP4 and SHBG biomarker in predictive performance for prematurity in this diverse cohort with blood draws earlier in gestation. The IBP4/SHBG biomarker pair may have broader application for predicting sPTB in diverse non-U.S. populations.
About Sera Prognostics, Inc.
Sera Prognostics is a leading health diagnostics company dedicated to improving the lives of women and babies through precision pregnancy care. Sera's mission is to deliver early, pivotal information in pregnancy to physicians, enabling them to improve the health of their patients, resulting in reductions in the costs of healthcare delivery. Sera has a robust pipeline of innovative diagnostic tests focused on the early prediction of preterm birth risk and other complications of pregnancy. Sera's precision medicine PreTRM® test reports to a physician the individualized risk of spontaneous premature delivery in a pregnancy, enabling earlier proactive interventions in women with higher risk. Sera Prognostics is located in Salt Lake City, Utah.
About Preterm Birth
Preterm birth is defined as any birth before 37 weeks' gestation and is the leading cause of illness and death in newborns. The 2020 March of Dimes Report Card shows that of approximately 3.8 million babies born annually in the United States, more than one in ten is born prematurely. Prematurity is associated with a significantly increased risk of major long-term medical complications, including learning disabilities, cerebral palsy, chronic respiratory illness, intellectual disability, seizures, and vision and hearing loss, and can generate significant costs throughout the lives of affected children. The annual health care costs to manage short- and long-term complications of prematurity in the United States were estimated to be approximately $25 billion for 2016.
About the PreTRM® Test
The PreTRM® test is the only broadly clinically validated, commercially available blood-based biomarker test that provides an early, accurate and individualized risk prediction for spontaneous preterm birth in asymptomatic singleton pregnancies. The PreTRM® test measures and analyzes proteins in the blood that are highly predictive of preterm birth. The PreTRM® test permits physicians to identify, during the 19th or 20th week of pregnancy, which women are at increased risk for preterm birth, enabling more informed, personalized clinical decisions based on each woman's individual risk. The PreTRM® test is ordered by a medical professional.
Sera Prognostics, the Sera Prognostics logo, The Pregnancy Company, and PreTRM are trademarks or registered trademarks of Sera Prognostics, Inc in the U.S. and/or other countries.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to broader application of the IBP4/SHBG biomarker pair for predicting sPTB in diverse non-U.S. populations; and the company's strategic directives under the caption "About Sera Prognostics, Inc." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: net losses, cash generation, and the potential need to raise more capital; revenues from the PreTRM test representing substantially all Company revenues to date; the need for broad scientific and market acceptance of the PreTRM test; a concentrated number of material customers; our ability to introduce new products; potential competition; our proprietary biobank; critical suppliers; the ongoing COVID-19 pandemic and its impact on our operations, as well as the business or operations of third parties with whom we conduct business; estimates of total addressable market opportunity and forecasts of market growth; potential third-party payer coverage and reimbursement; new reimbursement methodologies applicable to the PreTRM test, including new CPT codes and payment rates for those codes; changes in FDA regulation of laboratory-developed tests; the intellectual property rights protecting our tests and market position; and other factors discussed under the heading "Risk Factors" contained in our Final Prospectus on Form S-1, which was filed with the Securities and Exchange Commission on July 14, 2021, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Contact
Investor Contact
Peter DeNardo, CapComm Partners
[email protected]
+1 (415) 389-6400
Media Contact
Erich Sandoval, Lazar FINN
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+1 (917) 497-2867
SOURCE Sera Prognostics, Inc.
Related Links
https://seraprognostics.com
鹽湖城,2021年12月1日美通社/--血清預測者致力於通過向醫生和患者提供創新的懷孕生物標記物信息來改善孕產婦和新生兒健康的懷孕公司®(納斯達克股票代碼:SERA)今天宣佈發表一項研究,該研究由比爾和梅林達·蓋茨基金會資助,並與改善母嬰健康聯盟(AMANHI)合作,是一項旨在改善撒哈拉以南非洲和南亞孕婦和產後婦女及其嬰兒健康的跨國努力。這篇新發表的文章介紹了IBP4/SHBG生物標誌物對在低收入和中等收入地區預測自發早產(SPTB)的表現,並對人羣之間的人口差異進行了預先指定的調整。
SERA預測公司董事長兼首席執行官格雷戈裏·C·克里奇菲爾德(Gregory C.Critchfield)説:“SERA致力於解決早產帶來的全球性挑戰。今天公佈的數據表明,我們的生物標記物可以用來預測基線人口學和衞生保健可獲得性與最初驗證的美國人羣不同的患者羣體中的肺結核。我們相信,這些數據值得所有尋求改善產婦和新生兒結果並支持在更多人羣中進一步評估這些生物標記物的利益相關者仔細考慮。“
PreTRM®測試是在蛋白質組學早產風險評估(PAPR)研究中開發並在美國廣泛用於預測自發早產(SPTB)的。隨後,在美國第二項大型前瞻性研究-自發早產風險預測多中心評估(Treettop)研究中,這些生物標誌物被證明可以預測任何原因的極早早產、新生兒住院時間以及新生兒發病率和死亡率。現在,AMANHI樣本的生物標記物性能分析發表在同行評議的母胎與新生兒醫學雜誌在一篇題為“南亞和撒哈拉以南非洲婦女自發早產預測因子在南亞和撒哈拉以南非洲婦女中的表現:嵌套病例對照研究”的文章中:https://www.tandfonline.com/doi/full/10.1080/14767058.2021.2005573證實了通過對美國以外人口的預期人口差異進行預先指定的調整,對早產兒進行了TRM前生物標記物預測性能的確認。
AMANHI生物庫研究在孟加拉國招募了10001名孕婦,巴基斯坦和坦桑尼亞,對298例有代表性的妊娠進行了嵌套病例對照分析。這項工作證明,美國PreTRM®測試使用的生物標記物IBP4和SHBG,在對人羣之間的預期人口差異進行預先指定的調整後,可以顯著預測sPTB。正如美國的研究所證明的那樣,這些生物標誌物在預測肺結核方面表現良好。
關於Sera Prognostics公司
Sera Prognostics是一家領先的健康診斷公司,致力於通過精確的妊娠護理改善婦女和嬰兒的生活。SERA的使命是向醫生提供懷孕早期的關鍵信息,使他們能夠改善患者的健康,從而降低醫療保健提供的成本。SERA擁有強大的創新診斷測試管道,專注於早產風險和其他妊娠併發症的早期預測。SERA的精密醫學PreTRM®測試向醫生報告妊娠期間自然早產的個性化風險,使高危婦女能夠更早地進行主動幹預。Sera Prognostics位於猶他州鹽湖城。
關於早產
早產被定義為懷孕37周前的任何出生,是新生兒患病和死亡的主要原因。2020年3月的迪梅斯成績單顯示,在美國每年出生的大約380萬名嬰兒中,超過十分之一的嬰兒是早產的。早產與重大長期醫療併發症的風險顯著增加有關,包括學習障礙、腦癱、慢性呼吸系統疾病、智力殘疾、癲癇發作以及視力和聽力損失,並可能在受影響兒童的一生中產生巨大的成本。年管理早產兒短期和長期併發症的年度醫療費用美國2016年估計約為250億美元。
關於PreTRM®試驗
PRETRM®檢測是唯一一種經過廣泛臨牀驗證的、商業化的基於血液的生物標誌物檢測,可為無症狀單胎妊娠的自發性早產提供早期、準確和個體化的風險預測。PRETRM®測試測量和分析血液中高度預測早產的蛋白質。PRETRM®檢測使醫生能夠在懷孕第19周或第20周確定哪些婦女早產的風險增加,從而能夠根據每個婦女的個體風險做出更知情、更個性化的臨牀決定。PRETRM®檢查是由醫學專業人員開具的。
Sera Prognostics、Sera Prognostics徽標、懷孕公司和PreTRM是Sera Prognostics,Inc.在美國和/或其他國家和地區的商標或註冊商標。
安全港聲明
本新聞稿包含1995年“私人證券訴訟改革法案”所指的“前瞻性陳述”,包括有關IBP4/SHBG生物標記對在不同的非美國人羣中更廣泛地應用於預測sPTB的陳述,以及該公司題為“關於Sera Prognostics,Inc.”的戰略指示。這些“前瞻性陳述”是基於管理層目前對未來事件的預期,會受到一些風險和不確定因素的影響,這些風險和不確定因素可能導致實際結果與前瞻性陳述中陳述或暗示的結果大相徑庭。這些風險和不確定性包括但不限於:淨虧損、現金產生和籌集更多資本的潛在需要;來自PreTRM測試的收入幾乎代表了迄今為止公司的所有收入;PreTRM測試需要被科學和市場廣泛接受;重要客户的集中數量;我們推出新產品的能力;潛在的競爭;我們的專有生物庫;關鍵供應商;正在發生的新冠肺炎疫情及其對我們的運營以及與我們有業務往來的第三方的業務或運營的影響;對總的可尋址市場機會和預測的估計。適用於PreTRM測試的新報銷方法,包括新的CPT代碼和這些代碼的付款率;FDA對實驗室開發測試的監管變化;保護我們測試和市場地位的知識產權;以及在我們於2021年7月14日提交給美國證券交易委員會(SEC)的S-1表格最終招股説明書中“風險因素”標題下討論的其他因素, 以及我們在Form 10-Q季度報告、Form 10-K年度報告或Form 8-K當前報告中不時對這些風險因素進行的任何更新。本新聞稿中的所有信息都是截至發佈之日的信息,除非法律要求,否則本公司不承擔更新這些信息的責任。
聯繫人
投資者聯繫方式
彼得·德納爾多(Peter DeNardo),CapComm Partners
[受電子郵件保護]
+1 (415) 389-6400
媒體聯繫人
埃裏希·桑多瓦爾(Erich Sandoval),Lazar Finn
[受電子郵件保護]
+1 (917) 497-2867
來源:Sera Prognostics,Inc.
相關鏈接
Https://seraprognostics.com
譯文內容由第三人軟體翻譯。
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