According to its recently amended preliminary prospectus for its initial public offering, the company hopes to submit a 510(k) pre-market notification to the FDA for an automated test by the fourth quarter of 2011, and to have such a test on the market in the first half of 2012.
Magna is spearheading a public-private consortium to develop a point-of-care molecular testing platform based on magnetic nanoparticles and PCR amplification. Other partners in the consortium include the Fraunhofer Institute and Siemens.
The study supports the idea of more widespread nucleic acid-based HIV diagnostic testing, which could be a boon for Gen-Probe and Novartis Diagnostics, which offer the only approved NAT for qualitative HIV diagnosis in the US.
Siemens filed the rehearing request in response to a February ruling that Enzo's patent application covering its nucleic acid signal amplification technology predates and invalidates a patent owned by Siemens and relating to its branched DNA diagnostic systems.
Marine Biochem's enzymes are being used in diagnostic kits sold by Siemens and sample-prep kits being tested by another unnamed company — relationships Marine Biochem hopes will help spark its transition from a B2B vendor to a company that sells research tools directly to end users.