Precision Biosensor's US subsidiary receives FDA clearance for RSV test kit

Precision Biosensor, a Kosdaq-listed clinical diagnostics company specializing in in-vitro diagnostics (IVD), said on Wednesday that its U.S. subsidiary, Nano-Ditech Corp., has received official FDA 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver  for its respiratory syncytial virus (RSV) diagnostic product, the Nano-Check RSV Test.

The Nano-Check RSV Test is a rapid diagnostic product designed to detect RSV infections. It involves collecting a sample from the patient's nasal cavity and providing a visual result within 15 minutes. With its official FDA approval and CW, the test can now be used not only in professional laboratories but also in pharmacies and point-of-care testing (POCT).

This test is particularly important for diagnosing RSV in infants under six months and older adults, who are more susceptible to severe symptoms and may require hospitalization, Precision Biosensor said. Early diagnosis is crucial, as immunocompromised adults are also at risk of severe complications.

According to the Centers for Disease Control and Prevention (CDC), RSV is the leading cause of bronchiolitis and pneumonia in children under one year of age in the U.S. Annually, between 58,000 and 80,000 children under five are hospitalized due to RSV, with an estimated 100 to 300 fatalities. Additionally, 60,000 to 160,000 adults aged 65 and older are hospitalized each year, with approximately 6,000 to 10,000 deaths. 

Precision Biosensor’s Nano-Check RSV Test has expanded its application to include adults over 60, the company said, demonstrating its versatility through local clinical trials.

Earlier this year, Nano-Ditech Corp. secured FDA 510(k) clearance for its Nano-Check COVID-19 Antigen Test in January, followed by CW in June. The company also received emergency use authorization (EUA) for its Nano-Check Influenza+COVID-19 Dual Test, positioning it to address the anticipated rise in respiratory illnesses this fall. 

Kim Han-shin, CEO of Precision Biosensor, said that obtaining FDA approval for the Nano-Check RSV Test is a “significant milestone that highlights Nano-Ditech Corp.'s advanced technology and product excellence.”

With a strategic market launch beginning in California and Texas, Han added that the company plans to strengthen its market presence in the U.S. and expand its portfolio of infectious disease diagnostic products.