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Around the nation: FDA authorizes first at-home screening test for syphilis


FDA has authorized the first at-home, over-the-counter screening test for syphilis, in today's bite-sized hospital and health industry news from Illinois, Maryland, and North Carolina. 

  • Illinois: Walgreens announced that it signed a $100 million partnership with the U.S. government to conduct clinical trials to help with future emergency preparedness. Through the five-year partnership, which begins next month, the U.S. government aims to find new ways to reach diverse populations and help with future public health emergencies through the Decentralized Clinical Operations for Healthcare and Research program. "It is a privilege to continue our partnership with BARDA [Biomedical Advanced Research and Development Authority] to strengthen clinical research in the U.S. through a decentralized model in a community pharmacy setting like Walgreens," said Ramita Tandon, Walgreens' chief clinical trials officer. "Our network of community pharmacies and our compliant and secure clinical trial platform enables us to pioneer a comprehensive solution to make clinical research an integral part of a patient's healthcare journey, especially when it is most critical for the well-being of our country, during a public health emergency." (Japsen, Forbes, 8/19)
  • Maryland: FDA has granted market authorization for the first at-home, over-the-counter syphilis screening test from NOWDiagnostics. The test, which is called the First To Know Syphilis Test, detects Treponema pallidum antibodies in blood samples collected through a finger prick. The test takes 15 minutes to perform, and if it is positive, additional testing will be needed to confirm a diagnosis. According to NOWDiagnostics, the test was evaluated against three FDA-cleared laboratory tests in a clinical study with 1,270 participants. The First To Know test had a negative percent agreement of 99.5% and a positive percent agreement of 93.4%. According to MedPage Today, the authorization of an at-home syphilis test follows last year's authorization of the first at-home sample collection test for chlamydia and gonorrhea. "We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home," said Michelle Tarver, acting director of FDA's Center for Devices and Radiological Health. (Kahn, MedPage Today, 8/16)
  • North Carolina: According to a new poll from Premier, device and drug shortages have forced health systems to delay care and forgo revenue. In the poll, which included 102 hospitals, health systems, and suppliers, more than half of respondents said they had to cancel or reschedule procedures multiple times last year because of product shortages. Some items in shortage include syringes, IV fluids, saline, aortic balloon catheters, and surgical tourniquets. These shortages have also negatively impacted organizations' revenues, with mid-sized health systems seeing their care delivery costs increase by $3.5 million and revenue decrease by an average of $350,000. In response to these shortages, providers are planning to expand their supplier networks, work with more domestic manufacturers, and automate their supply chain technology. (Kacik, Modern Healthcare, 8/15)

3 steps for health systems to effectively leverage femtech in sexual and reproductive health

Femtech has emerged as a key opportunity for health systems to advance the health of women and nonbinary people. Explore our expert insights to learn how your organization can leverage femtech to bridge the gaps in sexual and reproductive healthcare.


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