CDC Influenza kit achieves FDA clearance

Quanta BioSciences, Inc., announced on Monday that its CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel Kit has received FDA clearance.

The announcement of FDA clearance comes after the CDC kit was granted emergency use authorization by the FDA on April 22. This authorization was granted for the CDC kit's characterization and detection of the H7N9 influenza.

The CDC kits, which are used for influenza testing, use Quanta's qScript One-Step qRT-PCR Low ROX, which is part of a portfolio regents developed to enable sensitive and specific performance of RT-qPCR and qPCR. This allows the CDC kit to keep working in the presence of inhibitors common in most public health samples.

Since samples from one source cannot always be reliable, the CDC kit is capable of working RNA and DNA that comes from stool, blood, saliva, mucus, soil and plant samples.

Quanta BioSciences, Inc., is located in Gaithersburg, MD. Quanta supplies reagents for RT and PCR applications in science, drug discovery and public health laboratories. Quanta's PCR and cDNA reagent portfolio is known for its reproducibility, specificity and sensitivity in the quantitative PCR market.