Global biotechnology tools company – Life Technologies Corporation (LIFE - Free Report) along with Quidel Corporation (QDEL - Free Report) recently received a 510(k) clearance from the US Food and Drug Administration ("FDA") to market a new Clostridium (C.) difficile test of Quidel with Life Technologies' Real-Time PCR Instruments. These products will be used together to fight hospital-acquired infections, commonly known as C. difficile bacterial infection (CDI). This approval complements Life Technologies’ ongoing strategy to expand in the growing diagnostics market with innovative clinical assays and molecular testing products.
The life-threatening CDIs are commonly observed among the growing number of elderly population, especially those who are on a prolonged antibiotic regimen and are on extended hospital stays. The recent data by the Centers for Disease Control and Prevention is quite shocking, as it shows that there are as many as 14,000 deaths annually attributed to CDI in the U.S., costing around a billion in excess treatment to the national healthcare system. Thereby, both the companies strongly believe in the need for a speedy and efficient diagnosis and as a result, are optimistic about the prospects of their new venture in this field of development.
Recently, Life Technologies undertook various measures to strengthen its diagnostics franchise. Last September, the company launched Pervenio Lung RS, a lab-developed test distinguishing high-risk from low-risk early stage lung cancer patients. Last month, the company received 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore HLA typing kits.
According to the company, the Applied Biosystems 3500 Dx/3500xL Dx CS2 Genetic Analyzers, Invitrogen SeCore HLA Sequencing Kits and uTYPE Dx HLA Sequence Analysis Software constitute the first 510(k)-cleared, sequence-based system for HLA typing in the U.S. Moreover, the 3500 Dx is the only 510(k)-cleared Sanger sequencer commercially available for the diagnostics market. Relying on the clearance, Life Technologies expects further development of assays using the 3500 Dx. In addition, the company has plans to submit its next-generation sequencing instrument, the Ion Torrent Personal Genome Machine (PGM), for 510(k) clearance.
Recently, Life Technologies entered a Master Development Agreement with Bristol-Myers Squibb for companion diagnostic projects. The collaboration with Bristol-Myers is in line with the company’s strategy of building partnerships with pharmaceutical majors for companion diagnostic development including the participation in early-phase clinical trials.
Earlier, the company formed a companion diagnostic partnership with GlaxoSmithKline's (GSK - Free Report) MAGE-A3 cancer immunotherapy and has an assay development partnership with Gen-Probe.
The company also strengthened its diagnostics franchise with three recent tuck-in acquisitions – Compendia Bioscience (Oct 8, 2012), Navigenics (Jul 16, 2012) and Pinpoint Genomics (Jul 25, 2012). Life Technologies expects a compounded annual growth rate ("CAGR") of 15% for its molecular diagnostic franchise through 2016.
The company now carries a Zacks Rank #3 (Hold). Another medical device stock worth a look is Cyberonics Inc. , which carries a Zacks Rank #2 (Buy).