Microbiologics Inc., St. Cloud, Minn, has announced a partnership with global antigen supplier Microbix Biosystems Inc, Mississauga, Ontario, Canada, to source inactivated viruses and incorporate them into a line of process controls under its Helix Elite molecular standards brand. The controls will also be used in instrument-specific quality control sets.
“We are pleased to use Microbix materials in Microbiologics products, as they have a strong, global reputation for high quality viral preparations for the vaccine and immunodiagnostics markets,” says Brian Beck, PhD, Microbiologics vice president for molecular products and services. “Incorporation of Microbix viral materials into our lyophilized, molecular-compatible formats complements our existing synthetic standards and extends our catalog to include extraction controls for gastrointestinal, respiratory, blood borne, and sexually transmitted viral pathogens.”
While molecular diagnostic assays offer sensitivity and speed, clinical laboratories may encounter challenges in locating adequate biomaterials for optimal test performance characteristics and staff proficiency. As a result, labs frequently use clinical samples that may not be consistent or well characterized. However, with the looming possibility of increased regulatory oversight for laboratory-developed tests, and new criteria to satisfy regulations for nonwaived tests under the Clinical Laboratory Improvement Amendments of 1988, clinical labs must carefully consider the source, quality, and format of their molecular and culture-based control materials.
The collaboration between Microbiologics and Microbix aims to combine both companies’ expertise in biomaterials development, preservation, and distribution to create highly stable viral controls for molecular testing worldwide.
“We are pursuing a multipronged approach to exploit the high-growth molecular diagnostics marketplace,” says Phil Casselli, senior vice president for business development at Microbix. “Microbiologics has relationships with instrument manufacturers, as well as large-scale distribution capabilities, making them an ideal partner to help expand the reach of our developing molecular program. Our unique isolates offering complements Microbiologics’ strengths. We will both be focused on what we do best in this relationship.”
Microbiologics continues to partner with industry leaders to develop advanced, yet practical controls that support the evolving field of molecular microbiology, says Brad Goskowicz, Microbiologics CEO. “We look forward to working with molecular diagnostic manufacturers to ensure that clinical laboratories have the appropriate and highest quality control material for their instruments and assays.”
Helix Elite molecular standards are listed as CE marked in-vitro diagnostic medical devices, allowing their use in clinical diagnostic applications globally. For a complete list of available standards, visit Microbiologics.