IntelligentMDx said this week that it has entered into a multi-year development and licensing agreement with Qiagen to design, develop, and manufacture several undisclosed assays for use on Qiagen's QiaSymphony RGQ automated molecular testing platform.
For IMDx, the agreement is an "important step" toward fulfilling its goal of becoming a "universal provider of gold-standard molecular diagnostic kits" for use on multiple instrument platforms, Alice Jacobs-Nesselrodt, chairman and CEO of the firm, told PCR Insider this week.
For Qiagen, the agreement will help the company "accelerate the expansion" of the QiaSymphony RGQ test menu beyond current offerings for infectious disease prevention and screening and oncology companion diagnostics, the company said in a statement.
Under the terms of the agreement, IMDx will develop several molecular diagnostic assays for the QiaSymphony RGQ that Qiagen will distribute worldwide. Qiagen has also retained the rights to assume manufacturing of the assays "pursuant to volume considerations," IMDx said in a statement.
Additional financial details were not disclosed.
IMDx, based in Cambridge, Mass., uses a bioinformatics process to predict success or failure of molecular diagnostic tests by simulating real-life conditions such as contamination or genetic mutations, which can impact a test’s clinical performance.
"The essence of it is taking into consideration the conditions … and evaluating clinically relevant sequence variants to ensure that the assay will perform well with clinical samples before you even get into the wet lab," Jacobs-Nesselrodt said. "Based on an instrument's requirements … we can input that into our bioinformatics [engine] and predict the likelihood that two pieces of nucleic acid are going to interact at a given temperature."
The upshot of this is that IMDx can significantly reduce assay design and optimization time, "from months to days," Jacobs-Nesselrodt said, allowing its partners who sell molecular testing platforms to more quickly build out their test menus.
"That's really been a great appeal for companies, large and small, that have built great instruments and want to have a set of core assays that they know is important for adoption of their instrument," Jacobs-Nesselrodt said.
Until this week, just one company had officially seen the appeal of this approach: Abbott, which two years ago entered into an agreement under which IMDx would design, develop, and manufacture molecular tests for Abbott's m2000 platform, which competes with Qiagen's QiaSymphony RGQ.
The tests covered by that agreement were to include assays for Clostridium difficile, vancomycin-resistant Enterococci; Group B Streptococci; herpes simplex virus types 1 and 2; and influenza A/influenza B, on a worldwide basis; and assays to determine viral load for Epstein-Barr virus and BK virus in the US.
Thus far, the Abbott-IMDx collaboration has produced CE marked tests for the first four of those targets, but not influenza. None of the Abbott-IMDx tests has been approved by the US Food and Drug Administration, although in 2009 IMDx received an emergency use authorization from the FDA for a 2009 H1N1 flu virus assay for use on the Applied Biosystems 7500 line of instruments, not the Abbott m2000.
Because IMDx's assay-development experience has primarily been in the infectious disease realm, it's a good bet that it will be developing similar assays for Qiagen under their partnership. However, Qiagen declined to comment further on the nature of the assays, and Jacobs-Nesselrodt was similarly reticent, citing confidentiality agreements.
In a statement, Dirk Zimmermann, vice president and head of global development for molecular diagnostics at Qiagen, noted that the company is "currently developing a range of new tests for use on [QiaSymphony RGQ], expanding beyond the already extensive range of tests covering profiling diagnostics as well as prevention/screening assays for a wide array of diseases. In addition, QiaSymphony is also our core platform for our assays in the area of companion diagnostics to guide treatment decisions."
Zimmermann added that the IMDx partnership "adds to the significant development efforts we are conducting internally and helps us to maximize the value of QiaSymphony RGQ for our customers by giving them the opportunity to consolidate an expanding range of molecular tests on one system."
Qiagen launched QiaSymphony RGQ in 2010 (PCR Insider, 9/1/2010). It is modular platform that comprises QiaSymphony SP for sample preparation, QiaSymphony AS for assay setup, and the Rotor-Gene Q real-time PCR thermocycler. Each module can be used individually or combined into a fully integrated system that incorporates all workflow steps from sample to detection, according to the company.
Qiagen launched the platform with several CE marked real-time PCR assays that it acquired along with Artus in 2005, including tests for detecting HIV, hepatitis C virus, hepatitis B virus, Epstein-Barr virus, herpes simplex virus, varicella-zoster virus, and BK virus. The company also offers CE marked assays for chlamydia/gonorrhea and various oncology-related gene targets.
In April of last year, Qiagen received 510(k) approval from the FDA for the Rotor-Gene Q instrument and the accompanying Artus Infl A/B RG RT-PCR kit (PCR Insider, 4/19/2012). The FDA approval did not include the other components of the QiaSymphony RGQ suite; however, at the time CEO Peer Schatz noted that the clearance paved the way for Qiagen to make its QiaSymphony RGQ assay portfolio available to clinical laboratories in the US.
Also at the time, a company spokesperson noted that Qiagen had filed for FDA approval of its Therascreen KRAS assay as a companion diagnostic for the colorectal cancer drugs Erbitux and Vectibix; and that in 2012 and 2013 it expected to file for approval of a Therascreen EGFR assay, Artus cytomegalovirus assay, and Artus assays for chlamydia and gonorrhea, HIV, and hepatitis C, among others.
It is unclear whether the assays being developed by IMDx will replace any of the above assays or complement them.
As for IMDx, although it has played primarily in the infectious disease space, Jacobs-Nesselrodt said that the company was looking to expand into other disease areas such as oncology, and that it is "in discussions" with potential partners outside the scope of infectious disease.
IMDx also has an ongoing partnership with Biosearch, which has granted IMDx access to its patents related to fluorophores and dark quencher dyes, and which manufactures cGMP oligonucleotides for IMDx's PCR-based diagnostic tests.
"We have a great relationship with Biosearch, and hope to continue working with them for all of our partnerships," Jacobs-Nesselrodt said.