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UPDATE: Thermo Fisher Claims First to Meet Draft ISO Guidelines to Prevent Forensic DNA Contamination

This article has been updated with comments from Qiagen and Promega.

NEW YORK (GenomeWeb) – Thermo Fisher Scientific announced today that it is the first firm to meet draft guidelines being developed by the International Organization for Standardization to minimize the risk of human DNA contamination in forensics products.

The firm's Warrington, UK manufacturing site was confirmed to be in adherence to the draft standard by a forensic quality and validation expert, the firm said.

Although uncommon, DNA contamination in a forensic DNA analysis laboratory can lead to erroneous results and negatively affect the outcome of criminal investigations, Thermo noted in a statement.

The standard, called ISO 18385, will apply to products used to collect, store, and analyze biological material for forensic purposes. The draft manufacturing standard was the result of a collaboration among forensic practitioners and industry experts, and included the participation of Thermo Fisher.

The company also recently launched a new system for targeted sequencing with a list of applications that included forensics.

Human DNA contamination occurring during the manufacturing process is rare. In one notable incident, called The Phantom of Heilbronn case, German authorities searched for a female serial killer whose DNA was recovered from 40 crime scenes and who was believed to have killed six people between 1993 to 2009, only to discover the lab was using sterilized cotton swabs that were likely contaminated during manufacturing and never recommended for DNA collection.

Historically, Thermo Fisher is one of two major manufacturers of reagents for PCR-based forensics testing. Promega also makes a line of forensics products, and in a recent white paper available online that firm noted that it, too, has contributed to the development of the new guidelines. "Once ISO 18385 is published, we will take any additional steps necessary to manufacture in alignment with the standard," the firm wrote.

In June of this year, Qiagen also launched a line of STR typing kits, an expansion that the firm said would build on its expertise in sample prep. 

The development process of ISO 18385 was originally initiated by Australia, Germany, the UK, and several other European and Asian countries in 2012, Qiagen told GenomeWeb in an email. "The company assisted with quality experts throughout the entire development process of ISO 18385 and is looking forward to its publication over the next few weeks," it said.

However, Qiagen said that due to the draft status, it believes no vendor at this point can claim to comply with the new standard, but it will have its entire Investigator PCR product portfolio and corresponding manufacturing sites compliant with the standard once it is published.

Likewise, Promega said in a statement sent to GenomeWeb that "self-declaration of compliance to the draft standard is premature."

It added, "Third-party certification by an accredited body will be a critical milestone for manufacturers and will be the best way for consumers to ensure that products claimed to be produced under ISO18385 are meeting consumer expectations. ... Promega looks forward to having the standard published and engaging both the self-declaration and third-party certification processes."