{"id":759697,"date":"2023-05-19T08:14:46","date_gmt":"2023-05-19T12:14:46","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/thermo-fisher-scientific-announces-fda-clearance-of-breakthrough-immunoassays-to-aid-in-the-risk-assessment-of-preeclampsia\/"},"modified":"2023-05-19T08:14:46","modified_gmt":"2023-05-19T12:14:46","slug":"thermo-fisher-scientific-announces-fda-clearance-of-breakthrough-immunoassays-to-aid-in-the-risk-assessment-of-preeclampsia","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/thermo-fisher-scientific-announces-fda-clearance-of-breakthrough-immunoassays-to-aid-in-the-risk-assessment-of-preeclampsia\/","title":{"rendered":"Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia"},"content":{"rendered":"

<\/p>\n

Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia<\/b><\/p>\n

First and only blood-based biomarkers for the risk assessment and clinical management of preeclampsia with severe features<\/i><\/p>\n

WALTHAM, Mass.–(BUSINESS WIRE<\/a>)–
\nThermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S PlGF plus KRYPTOR and B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.<\/p>\n

\nPreeclampsia is a life-threatening blood pressure disorder that can occur during pregnancy and the postpartum period. Preeclampsia is the leading cause of maternal and fetal mortality and morbidity worldwide, with incident rates that have increased rapidly in the United States over the last decade.<\/p>\n

\nThese new assays are designed to be used along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women who have been hospitalized for hypertensive disorders of pregnancy to determine if they are at risk of progressing to preeclampsia with severe features within the next two weeks.<\/p>\n

\n\u201cThermo Fisher is committed to advancing diagnostic solutions for reproductive health as part of our broader Mission to enable our customers to make the world healthier, cleaner and safer,\u201d said Alan Sachs, chief medical officer at Thermo Fisher Scientific. \u201cToday\u2019s clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the U.S.\u201d<\/p>\n

\nTesting of the blood-based biomarkers, B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S sFlt-1 KRYPTOR and B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S PlGF plus KRYPTOR, aids in the detection of the development of severe preeclampsia as validated by the PRAECIS study, which examined 18 U.S. hospitals, looking at more than 700 pregnant women across the country1<\/sup>. Women who test positive, based on the risk stratification ratio of the two assays (sFlt-1\/PlGF ratio \u2265 40), could receive enhanced surveillance and accelerated care before severe features develop.<\/p>\n

\n\u201cFDA clearance and availability of these novel biomarker tests throughout the country will allow caregivers to better manage and potentially improve outcomes for both mothers and their newborns,\u201d said Ravi Thadhani, MD, MPH, executive vice president of health affairs at Emory University and co-author of the PRAECIS study.<\/p>\n

\n“Patients and providers will benefit from having better tests to predict progression to preeclampsia with severe features, especially for those patients at risk of severe, early-onset disease or for whom there is some diagnostic uncertainty,” said Eleni Tsigas, chief executive officer at the Preeclampsia Foundation. “Our organization celebrates this result after many years of advocacy with leaders in research and regulatory bodies, such as the FDA, to accelerate the development and adoption of better clinical tools.”<\/p>\n

\nThese new assays are designed to run on the Thermo Scientific B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S KRYPTOR compact PLUS clinical chemistry analyzer. Using TRACE technology, based on Nobel Prize winning chemistry, the analyzer can deliver results in less than 30 minutes.<\/p>\n

\nFor more information on preeclampsia and the PRAECIS study, please visit: http:\/\/www.thermofisher.com\/preeclampsia<\/a><\/p>\n

\nReferences:
\n
[1] Thadhani R, Lemoine E, Rana S, et al. Circulating angiogenic factor levels in hypertensive disorders of pregnancy. NEJM Evid 2022; 1:EVIDoa2200161.<\/p>\n

About Thermo Fisher Scientific<\/b><\/p>\n

\nThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com<\/a>.<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20230519005071\/en\/<\/a><\/span><\/p>\n

\nMedia Contact Information:
\n
Sandy Pound
\n
Thermo Fisher Scientific
\n
Phone: 781-622-1223
\n
E-mail: sandy.pound@thermofisher.com
\n<\/a><\/p>\n

Investor Contact Information:
\n
Rafael Tejada
\n
Thermo Fisher Scientific
\n
Phone: 781-622-1356
\n
E-mail: rafael.tejada@thermofisher.com<\/a><\/p>\n

KEYWORDS:<\/b> Massachusetts United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> FDA Health Other Science Clinical Trials Research Science<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
Logo<\/b><\/font><\/td>\n<\/tr>\n
\"Logo\"<\/td>\n<\/tr>\n
<\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia First and only blood-based biomarkers for the risk assessment and clinical management of preeclampsia with severe features WALTHAM, Mass.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S PlGF plus KRYPTOR and B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication. Preeclampsia is a life-threatening blood pressure disorder that can occur during pregnancy and the postpartum period. Preeclampsia is the leading cause of … <\/p>\n

Continue reading “Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-759697","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nThermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/thermo-fisher-scientific-announces-fda-clearance-of-breakthrough-immunoassays-to-aid-in-the-risk-assessment-of-preeclampsia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia First and only blood-based biomarkers for the risk assessment and clinical management of preeclampsia with severe features WALTHAM, Mass.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S PlGF plus KRYPTOR and B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication. Preeclampsia is a life-threatening blood pressure disorder that can occur during pregnancy and the postpartum period. 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(NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S PlGF plus KRYPTOR and B\u00b7R\u00b7A\u00b7H\u00b7M\u00b7S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication. Preeclampsia is a life-threatening blood pressure disorder that can occur during pregnancy and the postpartum period. 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