ALPHARETTA, GA — Bako Diagnostics has expanded its molecular test portfolio to meet the U.S. need for the coronavirus testing, with results completed in 24 hours. The BakoDx COVID-19 test meets Centers for Disease Control and Prevention guidelines and will be offered under the U.S. Food and Drug Administration’s Emergency Use Authorization, with final approval pending.
The diagnostic laboratory, based in Alpharetta, began molecular testing for coronavirus on Monday. BakoDx is able to perform more than 2,000 tests per day, with plans to increase that capacity.
“Our development team has been working diligently to make COVID-19 testing more widely available and with 24 hour turnaround time for results,” said Ted Hull, CEO of BakoDx.
The BakoDx test was developed based on years of molecular experience and under CDC guidelines. The real-time polymerase chain reaction test has been validated to identify the virus from samples collected via nasal, nasopharyngeal, and oropharyngeal swabs.
“Utilizing nasal swabs to collect potential COVID-19 specimens will allow healthcare providers to oversee a patient collecting their own sample, while preserving personal protective equipment that has seen a major shortage across the country,” said Dr. Wayne L. Bakotic, Chief Medical Officer and co-founder of BakoDx.
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Healthcare centers with need for additional coronavirus testing capacity are asked to contact the lab through its website.
BakoDx is a biosafety level two lab and follows strict personal and environmental hygiene protocols, which have been further strengthened and reinforced with all employees since the early days of the coronavirus outbreak.
Specimens for coronavirus testing are not collected at the lab. For anyone who believes they may have contracted the virus, BakoDx urges them to seek medical advice to determine if testing is appropriate.
“We will work closely with state health officials and healthcare facilities needing additional testing for COVID-19, and increase test capacity in response to this public health crisis,” Hull said. “We understand the importance our lab plays in the safety of the public, patients, healthcare providers and our employees.”
If you are a clinician, call 1-855-422-5628 or visit bakodx.com for more information.
As of noon on Monday, there have been 229 deaths, 7,314 confirmed cases, and 1,332 hospitalized from coronavirus in Georgia. This is an increase of 18 deaths, 49 hospitalizations and 667 new cases since Sunday at noon.
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