FDA Clears Meridian's B. Pertussis Test - Analyst Blog

Meridian Bioscience, Inc. VIVO revealed that its new molecular diagnostic test for Bordetella pertussis has been cleared by U.S. Food and Drug Administration (FDA). It is the fifth assay on the company's illumigene platform and becomes the first FDA-cleared molecular stand-alone assay for Bordetella pertussis. Following the announcement, shares of the company went up 0.2% till the last trading session.

What is Bordetella Pertussis?

Bordetella pertussis is generally known as "whooping cough" and affects infants, children and adults. Each year, roughly 16 million people become affected by the disease leading to about 200,000 deaths.

In 2012, U.S. recorded more than 48,000 cases of pertussis infections. It is the highest number of cases reported in the nation since 1955.

How Advanced is Illumigene Pertussis?

Meridien's Illumigene Pertussis is superior to conventional Bordetella pertussis bacterial culture. The former presents a definitive result helping the patients to receive the antibiotic treatment on time.

The test also takes less time to deliver the reports (fewer than 60 minutes) and requires no expensive capital equipment. Its cost-efficient and fast delivery technology makes it a superior testing platform for rapid diagnosis.

In contrast, the conventional bacterial culture lacks sensitivity and takes more than a week for delivering the reports, endangering the life of the patient due to delayed treatment.
 
Meridian's Recent Launches

Last month, Meridian's wholly-owned subsidiary, Bioline, announced the global launch of SensiFAST cDNA synthesis kit. The synthesis kit is meant for scientists looking for consistent, unbiased, first-strand cDNA synthesis. It generates real-time ready first strand cDNA from viral RNA or total RNA.

In the same month, Bioline also announced the launch of its first kits in the new EPIK product range; EPIK Fast Quantification Kit and EPIK Amplification Kit. The development of the kits is aimed at meeting the needs of researchers employing PCR and real-time PCR analysis in Epigenetics.

Zacks Rank

Currently, Meridian carries a Zacks Rank #2 (Buy).  Investors interested in the medical products industry can also look at other stocks including Enzymotec Ltd. ENZY, St. Jude Medical Inc. STJ, and SurModics, Inc. SRDX. Enzymotec sports a Zacks Rank #1 (Strong Buy), while both St. Jude Medical and SurModics carry a Zacks Rank #2 (Buy).