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Luminex-Mayo Pact to Develop Thalassemia Dx Could Spawn Future xMAP Applications

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Luminex and Mayo Clinic have signed a development-licensing agreement in which Mayo will use Luminex’s xMAP flow-based assay technology to provide enhanced thalessemia testing services for its patients, officials from both organizations said recently.
 
As part of the agreement, Mayo researchers will continue to use the xMAP technology to develop improved diagnostic tests for other diseases, which Luminex will examine and possibly commercialize, Luminex said.
 
Under the terms of the licensing agreement, Mayo Clinic will add to its thalassemia genetic testing services for thalassemia a new molecular diagnostic test based on multiplex ligation-dependent probe amplification and bead-based liquid microarray technology using Luminex’s xMAP.
 
Financial terms of the agreement were not disclosed. However, according to Russell Bradley, vice president of business development and strategic planning for Luminex, the deal is akin to a “supply and development” agreement, in which Luminex licenses the use of the xMAP technology to Mayo in exchange for Mayo developing new applications for the platform.
 
“There was the fundamental licensing agreement, but there were some more aspects of it that were more collaborative, where [Mayo is] going to be looking at applying the platform for certain types of genetic tests,” Bradley told BTW. “We’re going to look on a case-by-case basis at the mutual interest from Luminex’s point of view of potentially working with Mayo to round out the development and potentially commercialize some of those [applications] outside of their institution or wherever we choose to take them.”
 
The first application and the subject of the recently announced agreement is a test for thalassemia, also known as Mediterranean anemia. According to Brian Dawson, chair of the division of laboratory genetics and associate professor at the Mayo Clinic College of Medicine, thalassemia may be caused by the loss of either the beta-globin or alpha-globin chains that make up hemoglobin.
 
In its mildest forms, the disease may not require any treatment, Mayo said. However, more severe forms may require regular blood transfusions, making early and accurate detection of the disease essential.
 
Dawson said that Mayo has been providing a molecular diagnostic for thalassemia for almost 20 years and that the Luminex technology has allowed it to develop a more advanced test.
 
“This assay is specific for looking for large deletions or duplications that lead to either the loss or gain of alpha-globin genes,” Dawson wrote in an e-mail to BTW. “These deletions or duplications are of various sizes, and this technology allows for the use of multiple DNA probes throughout the region to more easily determine the extent of the deletion or duplication, provides a much quicker time from receipt of sample to report, and avoids the use of radioactivity.”
 
Dawson also said that deletions within the promoter region that eliminate the production of alpha-globin mRNA can also be detected due to the use of additional DNA probes specific for that region.
 
Mayo said that the enhanced test has a turnaround time of two to three days, whereas previous methods required as many as 10 days.
 
Scientists in the clinical molecular genetics laboratory within Mayo’s department of laboratory medicine and pathology initially developed the thalassemia application; however, multiple Mayo Clinic laboratories and researchers, including Dawson, are now using the technology to ready it for clinical use, Dawson said.
 

“We’re going to look on a case-by-case basis at the mutual interest from Luminex’s point of view of potentially working with Mayo to round out the development and potentially commercialize some of those [applications] outside of their institution or wherever we choose to take them.”

Dawson also said that the early promise of using xMAP for a thalassemia diagnostic has attracted the interest of other research groups at Mayo that may want to develop diagnostics for other genetic diseases.
 
“Recent research has indicated that many diseases may be caused by the presence of large deletions or duplications [that] disrupt a gene or genes” Dawson said. “This technology allows for the rapid, accurate detection of these large deletions and duplications.”
 
He said that other Mayo researchers are using the technology to determine the presence of large deletions and duplications in other genes associated with diseases such as beta-thalassemia, primary hyperoxaluria, and polycystic kidney disease.
 
It is unclear whether Luminex will commercialize the thalassemia diagnostic or any other tests resulting from its agreement with Mayo, but the company is happy to have Mayo aboard as a potential application developer, Bradley said.
 
“The bottom line is that Mayo had done a lot of work on our platform, and developed an assay that they felt was an advantage that offered better care for patients,” Bradley said.”That was the basic driver. But it’s only one example. There are other types of tests that are similar [for which] places like the Mayo have unique access to patient samples, and are recognized testing facilities in the US.
 
“We had some specific examples of things we could work on today, and that they wanted to commercialize on the platform,” Bradley added. “And we left the rest open to, ‘Hey, if we can do this thing again in other areas, let’s do that.’”
 
Luminex has done some initial assessments on the commercial opportunity for the thalassemia test outside of Mayo, and Bradley said that the disease had already been “on Luminex’s radar screen” prior to the Mayo collaboration.
 
The commercial market for thalassemia testing is “healthy” in North America, Bradley said, but probably not the bulk of the opportunity. There is a “definite geographic component to where the opportunity is,” he added, and as such, it would be premature to call Luminex’s commercialization of the test a done deal. It is estimated that approximately 1,000 people live with thalassemia in the US, and the actual worldwide number of patients is unknown, thought it is estimated that an estimated 60 million to 80 million people in the world carry the thalassemia trait.
 
“The Mayo has a real need right now – real patients they want to test, and a process they want to improve, and we’re helping them do that with access to the platform,” Bradley said. “As they increase the menu there and look at other opportunities once the test is in place, we want to be there and work with them to see what we can do to support them. A lot of that is open – our crystal ball is not as good as it needs to be. It just seemed like a great opportunity to work with a very prestigious institution that can do the discovery, validation, and applied testing.”

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