By Turna Ray
PGXL Labs recently announced a partnership with diagnostics developer AutoGenomics that is part of a larger strategy to expand further into the personalized medicine space by developing tests in the cardiovascular, oncology, and psychiatry markets.
The Louisville, Ky.-based firm will use AutoGenomics' Infiniti analyzer for various personalized medicine applications. Specifically, PGXL plans to migrate genetic tests for warfarin sensitivity and Plavix response onto Autogenomics' Infiniti analyzer platforms, which have been cleared through the US Food and Drug Administration. Currently, PGXL offers CYP2C9 and VKORC mutation testing for warfarin dosing and CYP450 2C19 to gauge Plavix response on Luminex's xTAG and Tag-IT systems, respectively.
Migrating these "existing tests over to the [Infiniti] platform [will] give us greater flexibility in what we can offer our clients," PGXL President Roland Valdes Jr. told PGx Reporter this week.
The partnership with AutoGenomics will also allow the lab to expand the scope of its research offerings by adding new biomarkers to existing tests. For example, Valdes said that PGXL plans to add paraononase1, or PON1, testing for the anticoagulant Plavix, as well as IL-28B for interferon response to its research and early-stage clinical service menus.
In its portfolio, AutoGenomics also has a number of other research-use tests for pharmacogenomic mutations, such as KRAS, BRAF, and a host of CYP450 variants, which will be of interest to PGXL in its personalized medicine efforts.
This latest collaboration with AutoGenomics is part of PGXL's overall push to be a more visible player in the precision medicine space. "Personalized medicine is making the jump from theory to practice," Valdes said. "The AutoGenomics platform will help us rapidly adopt new tests and maintain the service level that is our focus."
To this end, in January, the company received a $200,000 forgivable loan from the Kentucky Economic Development Finance Authority, which PGXL will use to purchase equipment and grow its capacity. At the end of last year, the company announced it was tripling its laboratory space, which will house offices for its growing business staff.
Launched in 2005, PGXL garnered CLIA certification specifically for conducting pharmacogenetic testing. Now, recognizing that more and more personalized medicine products are moving from the research space to the commercial market, PGXL is gearing up to position itself at the center of PGx product development and market adoption.
Going forward, the firm plans to bring more tests into its product portfolio by partnering with in vitro diagnostics companies and work with doctors and hospitals to drive utilization of pharmacogenetic tests in the real-world setting.
In October last year, PGXL received a $3 million small business innovation research grant from the National Institutes of Health to conduct clinical trials of PerMIT: Warfarin, a software package that aims to help doctors use genetic data to determine the right dose of the anticoagulant for patients. PerMIT, being developed by ARUP and PGXL, previously received $2 million from the NIH for its initial development. The companies plan to seek FDA clearance for the software.
"It’s time to take the benefits of molecular diagnostic testing directly to physicians," Valdes added. "One of our strategic thrusts this year is to evangelize diagnostic testing to doctors who have never used molecular diagnostics before – to, in effect, get out into the broader medical market."
Last year, CVS/Caremark’s genetics benefits management subsidiary Generation Health selected PGXL to be one of its preferred genetic testing providers. As a lab working within CVS/Caremark's personalized medicine program, PGXL will provide testing services for people whose doctors are applying PGx strategies, approved by Generation Health to be clinically useful, to make treatment decisions.
PGXL also conducts contract research for drug companies. While companion diagnostics partnerships with pharmaceutical firms will be key to PGXL's growth in the personalized medicine space, Valdes could not name any drugmakers the company currently has relationships with due to confidentiality agreements.
Valdes also noted that PGXL has inked several unannounced partnerships with "companies that are developing assays to improve patient outcomes in areas of very specific need."
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