At home rapid flu test12/4/2023 Delivering this test to patients in their homes is just one more step towards achieving that goal." "Our mission has always been to help patients and healthcare providers test for any infection at any time in any location. "We are honored by BARDA's confidence in our team's ability to develop this test and bring it to market, and we're excited to be a part of the solution to keep kids in school, businesses operational, and minimize the spread of infectious agents," said Adam de la Zerda, PhD, founder and chief executive officer of Visby Medical. In addition to implications for timely treatment, the availability of a highly accurate at-home diagnostic will allow consumers to test, talk to a clinician, and receive the proper treatment in a single visit, which may help reduce the risk of community spread. "To achieve the best outcomes, patients and physicians don't have the luxury of waiting several days for an accurate diagnosis, and this test solves that piece of the puzzle." Gary Schoolnik, Visby Medical's chief medical officer and professor of medicine at Stanford University specializing in infectious diseases. "Antiviral treatments are now available for COVID and both flu strains, but they are most effective when given early in the patient's illness," said Dr. ![]() The new phase will support efforts to develop and obtain FDA clearance to offer the test directly to consumers via prescription develop a digital companion system designed to interpret test results and seamlessly connect the patient with providers and public health reporting systems. In the first phase of the contract, BARDA-supported efforts to obtain FDA emergency use authorization for Visby's rapid, single-use Flu-COVID PCR Test in CLIA-waived point of care settings. This incremental funding builds on the initial contract, announced February 2, 2021.ĭesigned for ease-of-use with minimal set-up time, the test offers a fast sample-to-result time of less than 30 minutes with an expected accuracy rate similar to lab-based PCR tests. SAN JOSE, Calif., Ma/PRNewswire/ - Visby Medical™, a leading medical diagnostic company, today announced that it has received an additional $25.5M in federal funding to develop and validate an at-home combination Flu-Covid test from the Biomedical Advanced Research and Development Authority (BARDA).The developmental-stage Flu-COVID PCR Test is a single-use, handheld, all-in-one PCR device that detects and distinguishes between influenza A, influenza B, and SARS-CoV-2 from one sample, delivers results in less than 30 minutes, and requires no additional equipment. ![]() Note : This are Medicare national limits and the amount of reimbursement for rapid influenza test may vary by State and private insurance carrier.Investigational diagnostic allows patients to test, speak to a provider, and receive proper treatment in a single visit The Consult Influenza test kit is CLIA Waived rapid flu test intended for Professional Use Only and is the responsibility of the medical professional to bill properly using the right ICD-9 and CPT-codes. Rapid diagnosis of influenza with a rapid flu test at the point of care is critical to ensuring that patients are able to receive these antiviral medications as quickly as possible.ĬPT Code and Reimbursement for the CLIA Waived Rapid Influenza Test Kit ![]() These drugs are most effective when administered within 48 hours at the onset of symptoms. Quickly identifying patients who are infectious with influenza will allow for appropriate treatment with antiviral medications such as Tamiflu or Relenza. During the flu season, using a rapid flu test to quickly diagnose influenza can help to reduce antibiotic use, allow for infection control and reduce overall costs related to additional diagnostic investigations. Respiratory tract infections are a common reason for prescribing antibiotics although many of these infections do not require such therapy. Flu season outbreaks occur each year during the fall and winter months.ĭifference Between Influenza and Common Cold It is a communicable disease that is easily transmitted through coughing and sneezing. Influenza is a highly contagious, acute, viral infection of the respiratory tract. Rapid diagnostic flu tests would be useful in clinical practice, especially when treating children and other patients at risk for flu-related complications. ![]() Every year millions of Americans see the doctor with flu like symptoms but only a small percentage will be positive. When the Consult Rapid Flu Test is performed with a nasal swab, it will differentiate between influenza A and influenza B using one simple.
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