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Meridian Bioscience gets the FDA’s green light for its neonatal saliva test Alethia

Its diagnostic test can detect the cytomegalovirus, a congenital infection that can lead to hearing loss
Pediatrician with a baby
The CDC estimates that 10% to 25% of childhood sensorial hearing loss can be attributed to cCMV

Meridian Bioscience Inc (NASDAQ:VIVO) received clearance from the US Food and Drug Administration for its neonatal saliva test Alethia to test for cytomegalovirus, a congenital infection that can lead to hearing loss.

Shares were up less than 1% to US$18.91 in Thursday morning trading.

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Around one out of every 200 babies are born with the cCMV infection, according to the Centers for Disease Control and Prevention.

The CDC estimates that 10% to 25% of childhood sensorial hearing loss can be attributed to cCMV.

Babies are at risk of contracting the infection during pregnancy if the virus in the mother’s blood crosses through the placenta.

“Unfortunately, cCMV infection is more common than other newborn related illnesses, like Group B Strep for example, yet the level of awareness is considerably lower. With Alethia CMV, we not only look to increase awareness, but also provide laboratories with an FDA-cleared test that they can use with confidence when diagnosing newborns with cCMV,” said CEO Jack Kenny in the company’s press release.

The infection can be detected in a baby’s saliva or urine within 2 to 3 weeks from birth.

The test has also been approved to detect a type of herpes virus in newborns.

 

Contact Lenore Fedow at [email protected]

Follow her on Twitter@LenoreMariee

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