The biotech company is led by Indian Americans Karthik Musunuri and Sandeep Jain.
Advaite, a biotech company led by two Indian American founders, is awaiting FDA approval for Emergency Use Authorization (EUA) of its “RapCov™ COVID-19 Rapid Test Kit” for the detection of IgG antibodies to the COVID-19 virus in human whole blood fingerstick samples.
With Karthik Musunuri, recognized in 2017 by Forbes magazine among its “30 under 30“ young entrepreneurs, as CEO, and Sandeep Jain, MD, a nationally recognized clinical-scientist, as Chief Scientific Officer, Advaite is in the final stages of FDA EUA review under EUA Submission #EUA202686. Approval will allow a national capability for widespread rapid screening for the presumptive detection of IgG antibodies to the COVID-19 virus in human fingerstick whole blood samples.
According to Advaite, the test offers significant advantages over other serology test kits for rapid deployment in ambulatory point of care settings. Many potential test users, from the states, private companies and not-for-profit institutions across the United States, have been looking for advances in innovation and manufacturing capabilities related to pandemic response to come from US based companies. Advaite is a Pennsylvania company, manufacturing in Philadelphia in an FDA registered GMP facility, with clinical data obtained only within the United States and from US patients.
According to Advaite, the RapCov™ test kits have been independently evaluated for their accuracy in multiple studies, with the specificity determined to be 98%, 100% and 98%, in three different rigorous evaluations conducted between April and the end of May.
“At this time”, Advaite CEO, Karthik Musunuri said, “we are regularly working closely with the FDA regarding specifications for the labeling and use of our test when it goes into widespread distribution.”
Musunuri continued, “this is particularly important because there is broad consensus in the public health community of the United States that the country still has a woefully inadequate capacity for testing related to COVID-19 and therefore cannot properly make decisions about businesses, schools and other aspects of our economy and our lives which can be allowed to operate safely, versus making decisions about openings and closings without adequate data.“
Indeed, the mantra of a nearly unanimous public health community across the United States since the early days of the pandemic has been, “test, test, test“ in order to devise strategies to simultaneously contain the virus and it’s progeny of illness and death, while allowing as much as possible of normal economic and social life to go forward in the nation.
The sort of technology being brought to market by Advaite, involving fingerstick blood testing of antibodies rather than reliance on the more invasive collection of venipuncture whole blood, serum or plasma, and, most importantly, offering rapid test results rather than the days’ or even weeks’ backlog we have seen in laboratory-based tests until now, is “just what the doctor ordered” to improve the American public health response to COVID-19.
Leading up to the November elections, public discourse on matters relating to testing, therapies and vaccines has increasingly been weaponized through the lens of politics, often ignoring data strictly based on science, but there are non-partisan advantages in manufacturing test kits in the US, using US-based technology and data, as compared to dependence on foreign nations.
Musunuri said, “We are looking forward to bringing easy to use, quickly scalable, COVID-19 tests, with rapid and reliable results, to the American people.”