By Manas Mishra
Dec 4 (Reuters) - Israeli startup Sight Diagnostics said on Wednesday the U.S. Food and Drug Administration had cleared its device that can process results for the most commonly needed blood test in about ten minutes.
The regulator's nod means that laboratories that run relatively lesser tests on a day to day basis may also be able to conduct the complete blood count (CBC) test with just two drops of blood.
"This could be a big change because at the moment a traditional analyzer can be placed in laboratories that run thousands of tests every week," said Sarah Levy, chief technical officer at Sight Diagnostics.
CBC is a blood test that gives a snapshot of one's overall health and can also used to detect leukemia.
Sight said the FDA clearance could bring down costs at laboratories with lower volumes, as traditional CBC tests which use a technology known as flow cytometry, normally require dedicated personnel to maintain the device, adding to costs.
The device, Olo, digitizes blood samples taken from either the finger or the veins, into images that are then interpreted by algorithms to process results in minutes, a procedure that can take as long as a day through traditional tests.
With the clearance, Sight is set to take on Quest Diagnostics and Laboratory Corp of America Holdings , the biggest players in the lab market.
Sight, which also has a system to detect malaria on the market, raised nearly $28 million in a series C funding in February.
The medical device maker keeps getting compared to Theranos Inc, infamous for making false claims about its blood tests, over and over again, Levy told Reuters in a phone interview.
Levy said the company was taking a step-by-step approach to diagnosing conditions with Olo unlike Theranos, which claimed it could use just one drop of blood to diagnose a range of conditions.
Theranos' founder Elizabeth Holmes was indicted https://www.reuters.com/article/us-theranos-ceo/theranos-founder-holmes-former-president-indicted-for-fraud-idUSKBN1JB2WP on charges of engaging in schemes to defraud investors and doctors in June last year. (Reporting by Manas Mishra in Bengaluru; Editing by Amy Caren Daniel)