About the Siemens Healthineers SARS-CoV-2 Molecular Test
Siemens Healthineers also announced that the FDA issued an EUA on May 5 for its molecular PCR Fast Track Diagnostics (FTD) SARS-CoV-2 Assay6 test kit, which can detect the virus that causes COVID-19. The FTD SARS-CoV-2 Assay also is CE marked for diagnostic use in the EU since April 24. In method comparison studies, the real-time PCR test has shown 100 percent positive agreement and 100 percent negative agreement7. The molecular test, of which more than 500,000 have already been sold in Europe, is compatible with many lab platforms and evaluates two targets in one test tube, detecting two genes with less test preparation. Sample-to-answer time, including extraction and generating the result, takes 2-3 hours, depending on the molecular system and lab resources employed.
"I'm proud of our team who saw the societal need and mobilized very quickly to bring this high-quality, diagnostic test to the U.S. market," said Deepak Nath. "Siemens Healthineers now offers the broadest portfolio of high-quality tests for SARS-CoV-2 to help address the global pandemic. Our tests arm healthcare professionals with the information they need to accurately detect SARS-CoV-2, assess disease severity and therapeutic response, and aid care management for patients with comorbidities or complications such as escalated immune response or sudden development of coagulation disorders. These tests will assist clinicians with more timely interventions that can result in better patient outcomes."
To meet demand, the company plans to ship more than 2.5 million molecular PCR tests per month worldwide as production capacity increases in May and June. The FTD SARS-CoV-2 Assay can be run on equipment widely used in laboratories worldwide and may be run simultaneously with Siemens Healthineers FTD Respiratory Pathogens 218 and FTD FLU/HRSV8 molecular syndromic testing panels that identify a wide range of pathogens that can cause acute respiratory infections.
About Siemens Healthineers Commitment to COVID-19 Testing
In addition to the antibody and molecular tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow up of COVID-19 patients. The company's broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for
COVID-19 patients.
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