Financings In Brief

Molecular diagnostics firm AutoGenomics Inc. seeks to raise up to $65 million in an initial public offering, according to a Sept. 26 prospectus filed with the Securities and Exchange Commission. The firm had initially filed for an IPO in July 2008, before the full impact of the global financial crisis, but formally withdrew those plans in May 2011. (See Also see "AutoGenomics IPO Will Support Trial Of HPV Test On Infiniti Analyzer" - Medtech Insight, 4 August, 2008..) AutoGenomics makes the 510(k)-cleared Infiniti automated molecular diagnostics analyzer system, which debuted in 2007 and currently performs 50 different mid- to high-volume tests on a single patient sample at the same time, commonly referred to as multiplexing. While the bulk of the tests are available only for research use in the U.S., the firm has 510(k) clearance for five of its genetic tests. AutoGenomics is working to finalize a clinical trial protocol to support a PMA application for two Infiniti tests for high-risk human papillomavirus – HPV-HR Quad and HPV-HR Hex – and plans to begin the trial in 2013. The firm also plans to pursue 510(k) clearance of an HPV genotyping test.

AutoGenomics expects to use the proceeds from the IPO to support the PMA filing and other regulatory submissions, for R&D, expansion of its sales force and manufacturing capacity, and for...