Skip to main content
Premium Trial:

Request an Annual Quote

Kapa Bio Lands ISO Certification

This story has been corrected to reflect that Roche has agreed to acquire Kapa Biosystems but has not yet completed the acquisition.


NEW YORK (GenomeWeb) – Kapa Biosystems today announced that it has received ISO 13485:2003 certification for the design, development, and manufacturing of molecular diagnostic kits and reagents for in vitro diagnostic applications.

To achieve the certification, Kapa expanded its quality management system, streamlined processes, implemented a validation program, and introduced additional risk-management steps, the firm said in a statement.

Luan Webber, Kapa Quality Assurance Manager, said that achieving ISO certification was a "critical step" for the Wilmington, Massachusetts-based firm. The firm can now begin producing reagents for use beyond the research market.

The certificate was granted by Lloyd's Register Quality Assurance.

Kapa supplies reagents to optimize enzymes in next-generation sequencing and PCR research applications. In August, Roche announced an agreement to acquire the firm for an undisclosed amount.

The Scan

Steps for Quick Review

The US Food and Drug Administration is preparing for the quick review of drugs and vaccines for the Omicron variant, according to the Wall Street Journal.

Moving Away From Using Term 'Race'

A new analysis finds that geneticists are using the term "race" in their papers less than in years past, as Science reports.

Point of the Program

The Guardian writes that some scientists have called the design of a UK newborn sequencing program into question.

Science Papers Present Multi-Omic Analysis of Lung Cells, Regulation of Cardiomyocyte Proliferation

In Science this week: a multi-omic analysis of lung cells focuses on RIT1-regulated pathways, and more.