By Ben Butkus
BD Diagnostics and Swiss pharmaceutical products and services firm Lonza said this week that they have inked an agreement to develop and commercialize Lonza's molecular assays on the BD Max system for pharmaceutical quality-control testing.
The deal marks the first time BD Max, BD's microfluidic-based, fully automated PCR testing platform, will be used in a pharmaceutical QC setting as the company looks to expand the market for the system outside in vitro diagnostic applications, according to a company executive.
Under the terms of the agreement, the financial details of which were not disclosed, Lonza has a worldwide exclusive license to co-market the BD Max system with its microCompass product line in selected fields.
Lonza' microCompass assays incorporate a variety of technologies, such as filter-based microorganism capture, cell lysis, RNA extraction, and reverse transcriptase PCR, to target ribosomal RNA to detect bacteria, yeast, and molds.
"They currently have some assays available on a manual PCR platform," David Panneton, worldwide vice president for industrial microbiology in BD's diagnostic systems division, told PCR Insider this week. "They are looking to port those assays and develop additional assays to put them on the BD Max, which is a fully automated, walkway PCR platform."
According to the companies, running microCompass assays on the BD Max will provide an automated platform with same-day results for quality-control testing in the pharmaceutical and personal care product markets.
BD and Lonza will face competition from several other players who have developed or are developing PCR-based testing platforms for pharmaceutical QC, including Life Technologies (PCR Insider, 7/8/10), Millipore (1/28/10), and Pall (9/23/10). Most of these companies are focusing primarily on Mycoplasma detection.
In a statement, BD and Lonza noted that the microCompass assays will facilitate rapid detection for total bioburden load, sterility testing, Mycoplasma, and a variety of specific, undisclosed organisms.
Panneton said that he could not disclose a full list of assays being developed under the collaboration due to their continued development. However, he said that they would likely be testing "for the usual list of [United States Pharmacopeia] objectionable organisms; other quality indicator organisms; and finally, I know they're also working on quantitation," Panneton said.
Once developed, Lonza will be responsible for marketing the assays through its direct sales channels, Panneton said.
BD brought the BD Max platform, née Jaguar system, under its umbrella when it acquired HandyLab last fall for $275 million. BD rejiggered and rebranded the platform with a plan to adapt its BD GeneOhm assays for methicillin-resistant Staphylococcus aureus, Clostridium difficile, and vancomycin-resistant Enterococcus to the instrument.
"We purchased BD Max for application in the IVD market," Panneton said. "We're building out a [hospital-acquired infection] testing platform. Meantime we're continuing to build the system out with target-specific assays for specific infectious disease organisms. But the first group we're looking at is HAIs."
In addition, in June BD Diagnostics received 510(k) clearance to market its BD Max GBS Assay for Group B Streptococcus on BD Max (PCR Insider, 6/3/10); and in August the test received "moderate complexity" designation from the US Food and Drug Administration under the Clinical Laboratory Improvement Amendments act (PCR Insider, 8/5/10).
Also in June, BD licensed from Exiqon Locked Nucleic Acid technology for use in infectious disease diagnostics (PCR Insider, 6/24/10).
Concurrent to these IVD pursuits, however, it appears the company is willing to explore other markets for the platform.
"We are an IVD company," Panneton said. However, he added, "we have a lot of rapid technologies and we're looking to leverage those technologies in adjacent market spaces, such as industrial microbiology."
BD is also embroiled in an ongoing legal battle with Gen-Probe regarding BD Max: In the past year Gen-Probe has filed a pair of lawsuits against BD alleging that BD Max infringes upon several patents owned by Gen-Probe and related to its Tigris molecular diagnostics blood-screening system (PCR Insider, 3/25/10).