logo
#

Latest news with #EXPAND

Natera Launches Fetal Focus™: A Noninvasive Prenatal Test for Inherited Conditions
Natera Launches Fetal Focus™: A Noninvasive Prenatal Test for Inherited Conditions

Yahoo

time07-08-2025

  • Health
  • Yahoo

Natera Launches Fetal Focus™: A Noninvasive Prenatal Test for Inherited Conditions

Launch supported by strong assay performance in first milestone readout of the landmark EXPAND clinical trial AUSTIN, Texas, August 07, 2025--(BUSINESS WIRE)--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA (cfDNA) testing and precision medicine, today announced the launch of Fetal Focus, a noninvasive prenatal test (NIPT) for inherited conditions. When a pregnant patient is identified as a carrier of a recessive single-gene condition, medical guidelines recommend partner testing in order to determine the risk for the baby to be affected by the condition1; however, in some cases the biological father is unavailable for testing. The Fetal Focus test was designed to address this unmet need. Now if a pregnant patient tests positive with Natera's Horizon™ carrier screen for one of the five most commonly tested genes, and if the father is unavailable for testing, Fetal Focus can screen the fetus directly for that gene by simply analyzing a sample of the mother's blood. Fetal Focus is validated for the analysis of five genes: CFTR (cystic fibrosis), SMN1 (spinal muscular atrophy), HBA1 and HBA2 (alpha-thalassemia), and HBB (beta-hemoglobinopathies, including sickle cell disease). The launch is supported by data from EXPAND, a large, prospective, blinded clinical trial. The study, which was initiated in 2023, has enrolled approximately 1,300 participants to date, reflecting a diverse, multi-ethnic population from leading academic medical centers and maternal fetal medicine clinics. EXPAND is designed to be the defining clinical trial in the category, with all outcomes, including both positive and negative results, confirmed by genetic truth using prenatal or postnatal diagnostic testing. In its first milestone readout (n=101) from EXPAND, the Fetal Focus test demonstrated 91% sensitivity and successfully identified 5/5 fetuses affected by homozygous variants.2,3 Homozygous cases, where the fetus inherits the same condition-causing variant from both parents, are especially challenging to detect. Fetal Focus uses Natera's proprietary LinkedSNP™ technology to improve detection of these cases across diverse populations. "Having access to a noninvasive option like Fetal Focus can provide critical information to support decision-making during pregnancy, especially in situations where partner testing isn't possible," said John Williams, M.D., chief principal investigator for EXPAND and director of reproductive genetics at Cedars-Sinai. "Fetal Focus adds another important offering within our comprehensive reproductive health portfolio – furthering our commitment to launching products that address clinical gaps in care and are supported by rigorous clinical validation," said Sheetal Parmar, M.S., CGC, senior vice president of medical affairs for women's health at Natera. "The EXPAND study has been underway for several years, and we're pleased to release this first milestone readout." References ACOG Committee Opinion #690, Mar 2017. Internal data on file. In EXPAND, the study participants and investigators are blinded to the Fetal Focus™ test results. EXpanding Prenatal Cell Free DNA Screening Across MoNogenic Disorders (EXPAND). Accessed July 2025. About Natera Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women's health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera's tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera's plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera's expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera's recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at and View source version on Contacts Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@ Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@ Sign in to access your portfolio

Comm Min's export promotion mission may have 12-point plan to push exports, help MSME exporters
Comm Min's export promotion mission may have 12-point plan to push exports, help MSME exporters

Time of India

time01-05-2025

  • Business
  • Time of India

Comm Min's export promotion mission may have 12-point plan to push exports, help MSME exporters

The commerce ministry's Export Promotion Mission (EPM), with a Rs 2,250 crore outlay, is set to launch with up to 12 components. These include easy credit schemes for MSMEs and e-commerce exporters, overseas warehousing facilitation, and global branding initiatives. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads The commerce ministry's Export Promotion Mission (EPM) is expected to feature up to 12 components, including easy credit schemes for MSME e-commerce exporters , facilitation of overseas warehousing, and global branding initiatives , to tap emerging export opportunities and strengthen trade tools for small businesses, an industry official said. The Directorate General of Foreign Trade (DGFT) showed a presentation on this mission to the representatives of export promotion councils and other key stakeholders on April DGFT has also sought the views of the councils on this before finalising the schemes under this EPM is divided into two broad categories - Providing Trade Finance Support ( NIRYAT PROTSAHAN ); and Driving International Holistic Market Access (NIRYAT DISHA) NIRYAT PROTSAHAN, six sub-schemes are under consideration; the Niryat Rin Vikas (NIRVIK) Sub-Scheme for MSMEs and new exporters; Support for Emerging Export Opportunities; Support for Trade Instruments for MSMEs; Collateral Support for Export Credit for MSME exporters; E-commerce Export Credit Card Sub-Scheme; and BharatTradeNET, the official in the NIRYAT DISHA initiative, there are also six elements. These are Technical Regulations and Compliance Enablement (TRACE); Focussed Market Access Initiative (FMAI); Facilitating Export Logistics and Overseas Warehousing (FLOW); Global Outreach for Branding Exports (GLOBE); Export Planning and Development for Districts and Clusters (EXPAND); R&D Support Sub-Scheme for India Centre for Lab Grown Diamond (InCent-LGD) at IIT Madras, official added that these sub-schemes will be implemented through a digitally enabled application and monitoring system, anchored around an online 'intent to claim' objective of the NIRVIK sub-schemes is to establish a dynamic and responsive interest equalisation support framework that enables MSMEs to access export credit in rupee (INR) at globally competitive rates."This will be achieved through the periodic notification of NIRVIK rates, which will be benchmarked against prevailing interest rates offered to exporters in countries that compete with India in international trade," the official would be applicable to MSME exporters availing export credit, subject to a specified cap limit for interest subvention. However, this cap shall be reviewed periodically based on the actual a negative list of export items would be maintained under the scheme and no interest subvention shall be provided for items included in this negative negative list is prepared based on criteria such as low-value addition and high outgo, raw materials and primary products, high-value and potential items for misuse, and other sensitive Items."There will be an annual notification of NIRVIK rates, which will be benchmarked against prevailing interest rates offered to exporters in countries that compete with India in international trade," another official collateral support for export credit for MSME exporters sub-scheme's objective is to provide back-up collateral upwards of 80 per cent or as decided by the collateral support agency to MSMEs and e-commerce exporters, based on the composite track record of the government on February 1 announced the setting up of an Export Promotion Mission with an outlay of Rs 2,250 crore to promote the country's outbound Minister Nirmala Sitharaman has said that through the mission, the government will facilitate exporters to get easy access to credit, cross-border factoring support, and support MSMEs to tackle non-tariff measures in overseas markets.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store