Northwell Health Labs, a health-based laboratory in the United States, has recently received federal authorization to immediately begin processing tests for COVID-19. The laboratory is a 100,000-square-foot diagnostic facility in Lake Success, U.S.
Sources familiar with the matter stated that the laboratory can start the manual testing of 90 potential samples of COVID-19 on the 1st day of operation. Northwell Labs is seeking further approval for automated testing from the U.S. Food & Drug Administration. The automated tests could manage an increased number of tests per day, up to 100 daily tests.
According to Northwell Labs’ executive director, Dr. Dwayne Breining, the validation of accuracy levels of the testing process has added impetus to the company’s plans to notify patients and providers with the accurate lab results and to achieve the capability to process thousands of tests per day through the automated testing process, that is currently awaiting FDA approval.
Prior to gaining federal approval, Andrew M. Cuomo, the Governor of New York, had visited Northwell Labs amid concerns regarding the delayed approval to process COVID-19 tests in the facility that could possibly perform high-throughput automated testing.
Mr. Cuomo expressed his criticism of the U.S. Disease Control & Prevention Centers for not speeding up the testing of the deadly virus at their own laboratories, right after the confirmation of the first coronavirus case in the region, earlier this year. He further stated that the approval of more state and private clinical laboratories is a necessary step towards increased capacity of virus detection in the region. It will greatly enhance the ability to manage COVID-19 spread, by rapidly identifying the infected people and isolating them to contain the coronavirus.
The only clinical laboratories that could initially process the samples of the possible cases, before Northwell Labs gained approval, were the Wadsworth lab or the Public Health lab in New York City.