By Ben Butkus
UK-based molecular diagnostics firm Biofortuna this week introduced what it said is the first-ever complete freeze-dried PCR kit for human leukocyte antigen genotyping applications.
Biofortuna anticipates that the new kit, called SSP Go, will "revolutionize" the PCR market because it can be transported and stored at ambient temperatures and can be used by relatively unskilled technicians, making it suitable for applications on a "global scale," Harry Singh, Biofortuna's commercial director, told PCR Insider this week.
And although Biofortuna will initially target the product at the transplantation market within hospitals and blood banks, Singh said that down the road the kit could benefit a wide range of applications, such as pharmacogenetic test development and administration.
SSP Go is an off-the-shelf, freeze-dried, lyophilized PCR mix containing all buffers, primers, and Taq polymerase. The kit does not require separate buffers or enzymes, which minimizes the risk of user error or contamination, according to Biofortuna.
In addition, SSP Go is stable for more than a year at temperatures up to 37°C, which eliminates the need for thermal packaging, refrigeration, or freezers for kit storage.
"The end user gets a complete PCR reaction, and all they have to do is add the DNA and place it onto a PCR machine," Singh said. Although Biofortuna has not tested the kit on every commercial PCR system available, Singh said that "there is no reason the kit shouldn't be compatible" with any machine.
The company has filed for patents surrounding its freeze drying methodology. "There is a specific way to do it so that the components do not degrade, and so that the Taq is still usable, and the primers are still specific," Singh said.
One recent tweak the company made to the product was to incorporate TriLink BioTechnologies' CleanAmp dNTPs into the SSP Go kits in order to improve specificity (PCR Insider, 9/16/10).
Biofortuna developed SSP Go to address a need in HLA molecular genetics, which is the company's primary area of expertise. Singh said that Biofortuna's CEO Mike Bunce has worked in the HLA market for the past 30 years, and that HLA was a "very straightforward, very clean application" for the freeze-dried PCR kit.
PCR amplification within the HLA market primarily uses sequence-specific primers, hence the "SSP" moniker for the product.
"It's effectively an [amplification refractory mutation system] reaction, so if you have a primer set that matches a mutation in your DNA template, you'll get an amplicon, and therefore you'll see a band," Singh said. "If you do not have a match of your primer and template, you don't get priming and can't see anything."
Singh added that an SSP Go product can "be placed on a gel electrophoresis system and it's pretty robust to determine whether or not you have an amplicon," Singh said. "And there is a need for quick, reliable results within tissue type testing."
Biofortuna will initially target the HLA transplantation market in Europe with SSP Go, since the kit has the CE Mark for such applications but does not currently have US Food and Drug Administration approval. Singh said that the company has just begun the process of seeking 510(k) approval in the US for the kit.
"Of course it could be for research use only, but the labs we want to sell it to are mostly clinical laboratories that need to have 510(k) [approval]," Singh said. "But we are trying to raise our profile in the [US] so that once we do have an approved product we can hit the ground running."
Beyond that, Biofortuna expects that the kit "allows us to open up a market which is already established but allows us to exploit areas on a global scale where maybe countries have limited electricity and therefore [few] fridges and freezers," Singh said. Further, the simplicity of the kit makes it ideal for use by relatively untrained staff at hospitals and blood banks, who can "just give this work to junior technicians, and that’s not just in developing countries," thereby freeing up time for more senior-level healthcare workers, Singh added.
Singh said that tissue-typing labs within the UK's National Health Service trust are currently testing the new kit. In addition, he said that the company will begin targeting organizations such as the UK National Blood Service, and is "in sensitive discussions at the moment … looking at how to promote this on a global scale."
If Biofortuna is able to establish sales of the kit within the HLA market, it will turn its attention to other promising applications, such as pharmacogenetics, which could benefit from the same "global" access to PCR kits. "If you think of our test, which is robust and has a low technical grade in terms of the ability to do the test, you can think of how it can be used on a global, mass scale alongside a drug that will give you reliable consistent results," Singh said.
In addition, the company said last November that it was collaborating with Edinburgh, UK-based Lab901 to develop an automated PCR-based diagnostic system incorporating SSP Go to rapidly detect celiac and other diseases related to HLA status (PCR Insider, 11/17/2009).
Singh said this week that Biofortuna has formally signed a distribution agreement with Lab901 that allows Biofortuna to distribute Lab901's system and associated consumables in the UK. "We have also developed tests on their system which we are currently promoting," Singh said.
Biofortuna itself is also developing a range of HLA diagnostic kits for the transplantation, blood grouping, disease identification, and pharmacogenetic markets.
Singh said that based on the initial interest shown in the new freeze-dried kit, Biofortuna expects that it will experience 25 percent year-over-year growth in sales this year. "The feedback has been tremendous," he said. "We've already got sales, and we're looking at how to develop larger customers and markets."
Biofortuna said that it is demonstrating the new product this week at the British Society for Histocompatibility and Immunogenetics conference in Edinburgh and the American Society for Histocompatibility and Immunogenetics annual meeting in Miami.