Enzymatics Implements ISO 13485:2003, Increases Emphasis on Molecular Diagnostics

Market Wire, October, 2008

Enzymatics ( http://www.enzymatics.com ), specializing in the large-scale production of high quality enzymes, including a wide-range of enzymes for DNA sequencing and diagnostics, has implemented ISO 13485:2003.

"ISO 13485:2003 specifies requirements for a quality management system relating to medical devices," according to Stephen Picone, Enzymatics President. "In order to better meet our customers' evolving regulatory requirements, we have determined that operating to the ISO 13485 standard is in the best long-term interest of the Company. The system has been deployed in conjunction with ISO 9001:2000, and certification to both standards is expected in November, 2008."

New, High Quality Enzyme Production Techniques Propel Enzymatics To Record-Setting Year

According to Chris Benoit, Enzymatics Chief Operating Officer, "In spite of the turbulent conditions and increased competition in the life sciences industry, Enzymatics anticipates finishing 2008 with record levels of business, more employees, expanded facilities and ISO Certifications. We are on track to post triple digit growth for 2008.

"We have applied an innovative approach to the development, optimization, and scale-up of recombinant biomolecule production to increase the reliability and profitability of our customers' consumables business segments. Utilizing newly developed strategies, Enzymatics has refined the biological reagents production process, resulting in a measurable increase in the quality of our products while maintaining the flexibility to be price competitive," he said.

About Enzymatics

Enzymatics is unlocking the potential of consumer genomics by delivering high value molecular biology enzymes to drive cutting edge nucleic acid detection technologies. The Company's technical team applies its world-class skill in the development of biologics to produce a growing suite of enzymes manufactured to analytical specifications under strict levels of compliance. Please visit us at www.enzymatics.com .

FOR FURTHER INFORMATION CONTACT: Christopher Benoit Chief Operating Officer Enzymatics 888-927-7072 x.11 benoit@enzymatics or Steven Swartz SIZZLE PR 978-524-9595 Email Contact

 

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