Clinical Validation Study for First Triage Test Completed
Medical research company Exact Diagnostics has announced the successful completion of its first clinical validation study for a new rapid diagnostic test for Covid-19.
The genomic testing company partnered with private labs and clinics in the United States to conduct a real-world clinical validation for the new diagnostic test, which was designed to provide timely and reliable results for Covid-19. According to a statement from the company, the clinical validation study was conducted over a one-month period and involved screening 60 patients and more than 1,000 samples.
The diagnostic test was validated to detect the SARS-CoV-2 virus, the virus that causes Covid-19. It has a unique three-component model of bio-signal capture, sample capture and result interpretation that provides near-real-time results. The study’s results showed that the sensitivity of the test was nearly 98 percent and its specificity was 99.7 percent.
Exact Diagnostics CEO Steve Gendel said the study results were “very encouraging” and demonstrated “the excellent diagnostic performance that our technology provides.”
The company said it plans to move forward with further trials and eventual commercialization of the test as additional studies are conducted. The test is already being used in clinical settings so that healthcare providers can better manage the Covid-19 pandemic and better treat patients.
Exact Diagnostics’ Covid-19 diagnostic test is further evidence of the potential of rapid, accurate and cost-effective molecular surveillance capabilities. This type of testing is becoming increasingly important as countries around the world continue to face the ongoing threat of the virus.
The successful clinical validation of Exact Diagnostics’ Covid-19 test could lead to a new wave of advanced molecular diagnostics capable of meeting the demands of modern healthcare. With the successful completion of its first clinical validation study, the company has set a new benchmark in developing rapid diagnostic tests for infectious diseases.
Clinical Validation Study for First Triage Test Completed
Medical research company Exact Diagnostics has announced the successful completion of its first clinical validation study for a new rapid diagnostic test for Covid-19.
The genomic testing company partnered with private labs and clinics in the United States to conduct a real-world clinical validation for the new diagnostic test, which was designed to provide timely and reliable results for Covid-19. According to a statement from the company, the clinical validation study was conducted over a one-month period and involved screening 60 patients and more than 1,000 samples.
The diagnostic test was validated to detect the SARS-CoV-2 virus, the virus that causes Covid-19. It has a unique three-component model of bio-signal capture, sample capture and result interpretation that provides near-real-time results. The study’s results showed that the sensitivity of the test was nearly 98 percent and its specificity was 99.7 percent.
Exact Diagnostics CEO Steve Gendel said the study results were “very encouraging” and demonstrated “the excellent diagnostic performance that our technology provides.”
The company said it plans to move forward with further trials and eventual commercialization of the test as additional studies are conducted. The test is already being used in clinical settings so that healthcare providers can better manage the Covid-19 pandemic and better treat patients.
Exact Diagnostics’ Covid-19 diagnostic test is further evidence of the potential of rapid, accurate and cost-effective molecular surveillance capabilities. This type of testing is becoming increasingly important as countries around the world continue to face the ongoing threat of the virus.
The successful clinical validation of Exact Diagnostics’ Covid-19 test could lead to a new wave of advanced molecular diagnostics capable of meeting the demands of modern healthcare. With the successful completion of its first clinical validation study, the company has set a new benchmark in developing rapid diagnostic tests for infectious diseases.
