Clinical laboratory diagnostics has become an important area of investment and business transactions. Recently, Mesa Laboratories, a biotech company focused on quality control solutions for pharmaceutical, healthcare, and medical devices, announced the acquisition of Agena Bioscience for a cash purchase price of $300 million. According to the press release, Mesa is expected to pay for the acquisition through cash on hand and credit. The acquisition is expected to be completed by the end of the year pending regulatory approval and met conditions of the agreement. With current yearly revenues around $65 million and an additional $3-$5 million in COVID-19 revenues, Agena Bioscience is expected to greatly contribute to Mesa Laboratories’ solutions lineup.
An important consideration in this deal was the MassArray system, a combination platform of MALDI-TOF mass spectroscopy and multiplex PCR. Built to test for and identify clinically relevant mutations, the MassArray system has found a host of important applications in the clinical diagnostics setting, including a Dx Lung Panel, a Dx colon panel, and more recently an Emergency Use Authorization (EUA) for the iPLEX Pro SARS-CoV-2 Panel for qualitative detection of the coronavirus that causes COVID-19. The upside for this system is throughput, with the system able to run more than 6,000 samples in one day.
The success of the MassArray system in clinical diagnostics is indicative of a broader trend for MALDI-TOF systems that have been approved for clinical use in several regions including the United States, Europe, and China. Clinical diagnostics has been addressed by MALDI-TOF with offerings from several companies besides Agena Bioscience. bioMérieux offers the VITEK-MS, an FDA cleared, and CE marked device that excels at microbial identification and has a large library of clinically relevant tests. Bruker offers the MALDI Biotyper CA, another automated system like the VITEK-MS that excels at bacterial identification, with constant updates to their reference libraries for new species of a variety of bacteria, anaerobes, and yeast.
Further data and analysis relating to this active market can be found in SDI’s latest publication, the 2021 Mass Spectrometry Market for Clinical Applications, which provides an in-depth look at the rapidly growing clinical market for mass spectrometry. This report contains market size, growth rates, vendor shares, and commentary for select technologies operating in the clinical mass spectrometry marketplace. These technologies include GC/MS, LC/MS-MS, Q-TOF LC/MS, FT/MS & Ion Trap, and ICP-MS. The report also provides the latest information on new IVD approvals of mass spec products, new system introductions, and supplier collaborations.