FDA Issues Draft Guidance for Pathogen-Detection IVDs
The US Food and Drug Administration last week released a draft guidance for industry on the types of information the agency would consider during the premarket review of nucleic acid-based in vitro devices that detect exposure to pathogens.
The draft document, which represents the FDA's current thinking on nucleic acid-based in vitro diagnostic devices, comes at a time when the US government and many companies are actively engaged in developing microarrays and diagnostics tools to detect and manage such pathogenic diseases as bird flu and anthrax (see story, this issue).
The FDA acknowledged the recommendations are "purposefully" general as they are intended to be a "framework" for the types of data that should be addressed in the premarket review of these devices.
The 26-page document, which can be found on the agency's website, outlines its recommendations under four headings: Risks to Health, Device Descriptive Characteristics, Performance, and Labeling.
The section on risks recommends providing sufficient detail to indicate the device has been designed to reduce errors in performance or in interpreting test results. Device Characteristics seeks information on the patient population to be tested, targeted disease and organism, testing methods, reagent components, instruments to be used, and safety aspects.
Under performance, the recommendations specify data indicating reliability, diagnostic accuracy, and reproducibility. Finally, labeling requests information on how specimens were collected and the types of collection devices used.
The guidance document is intended to offer the "least burdensome" approach, the FDA said. The agency invites comments and suggestions regarding the recommendations outlined in the draft document within 90 days.
PerkinElmer Completes Sale of Aerospace Unit
As part of its divesture of non-life science businesses, PerkinElmer completed the sale of its aerospace business to Eaton, the Boston-based company said last week.
Amounts were not disclosed, although the company said in October that the aerospace business would yield $333 million (see BAN 10/12/2005).
That month, PerkinElmer said it would sell its aerospace, fluid sciences, and semiconductor businesses to shift its focus to the health sciences and photonic markets. PerkinElmer has said it expects to gain approximately $77 million from the sale of the semiconductor and fluid sciences businesses. The company is still in discussions to sell its semiconductor business.
According to PE, the divestitures reveal the company's emphasis on genetic screening, medical imaging, molecular medicine and service. Daniel Sutherby, PE's vice president of investor relations, told BioArray News in October that due to the sales, PE will have more cash next year to funnel into its life and analytical science businesses.
Stratagene and Strand to Co-Develop Software That
Analyzes Systems Bio Pathways, GeneChip Arrays
Stratagene and Strand Life Sciences plan to develop bioinformatics software to analyze systems biology-focused pathways and Affymetrix's new GeneChip microarrays, the companies said last week.
Terms of the agreement call for the companies to co-design and -develop software, which will include Strand's Avadis technology. Stratagene will exclusively market and sell the two products"shortly," the companies said.
Both Stratagene and Strand were among the initial 14 companies to join Affymetrix's Gene Chip compatible program in September (see BAN 9/14/2005).
Affymetrix also agreed in February that it would use Stratagene software for GeneChip data analysis, and as part of that non-exclusive license, Stratagene developed its ArrayAssist Lite package, which has been offered as a standard statistical analysis tool for Affy arrays (see BAN 2/9/2005).