This article, originally published April 19, has been updated from a previous version to include comments from an Abbott spokesperson.
Biofortuna said today that it has inked an exclusive manufacturing and distribution agreement with Abbott related to freeze-dried PCR kits for human leukocyte antigen genotyping applications in the transplantation market.
Under the agreement, Biofortuna will design, develop, and manufacture a range of freeze-dried HLA-typing kits with the brand name SSPGo for Abbott's molecular diagnostics business.
Abbott will obtain exclusive distribution rights in the US and all global territories, apart from France, Spain, Portugal, and the Benelux countries, once regulatory approvals are obtained. The agreement includes rights to distribute the SSPGo products, Biofortuna's interpretation software Verdict, as well as kit updates and improvements, Biofortuna said.
Biofortuna said that its kits will be available to laboratories outside the US to purchase and order through Abbott in June. The kits are currently CE-marked and have been submitted for US Food and Drug Administration approval, the company said.
Financial terms of the agreement were not disclosed.
In an e-mail to PCR Insider, an Abbott spokesperson said that Biofortuna's products are commonly used for testing solid organs, such as kidneys, which are the most common transplanted organ.
As such, Biofortuna's kits "complement Abbott's existing line of high-resolution HLA sequence-based typing products, which we distribute as part of an agreement with Celera Diagnostics. These include analyte-specific reagents in the US and CE-marked products outside the US, typically used for HLA testing for bone marrow or peripheral blood stem cell transplant procedures."
The spokesperson added that Biofortuna's products "also fit well with Abbott's overall renal franchise, which includes therapeutics, nutritional supplements, and tests for renal conditions."
Biofortuna introduced SSPGo, the first-ever complete freeze-dried kits for HLA typing, in September (PCR Insider, 9/30/10). The kits include lyophilized PCR mix containing all buffers, primers, and Taq polymerase, and are prepared using proprietary freeze-drying technology that renders them stable at ambient temperature for up to 16 months, eliminating the requirement of refrigerators, freezers, and temperature-controlled shipping.
The kits do not require separate buffers or enzymes; and users need only add DNA to perform PCR, which results in cost and time savings by reducing labor, consumables, and the potential for errors, the company said.
"We are delighted to have signed this agreement with Abbott," Mike Bunce, founder and CSO of Biofortuna, said in a statement. "Biofortuna's expertise in HLA and freeze-drying combined with Abbott's sales and marketing infrastructure and excellent customer support will meet the growing demand for our kits."
Biofortuna said that it is developing other freeze-dried molecular diagnostic products for the transplantation and pharmacogenetic markets, as well as a portfolio of tests "with the aim of providing easy-to-use diagnostics that address complex genotyping issues," the company said in a statement.
In September, BioFortuna said that it would incorporate TriLink BioTechnologies' CleanAmp dNTPs into its SSPGo kits in order to improve specificity (PCR Insider, 9/16/10).
Biofortuna also has in place a collaboration with Edinburgh, UK-based Lab901 to develop an automated PCR-based diagnostic system incorporating SSPGo kits to rapidly detect celiac and other diseases related to HLA status (PCR Insider, 11/17/2009).