A recent publication in the Journal of Precision Medicine highlights QIAGEN’s companion diagnostic business development and Modaplex platform.
The July 2016 issue of the Journal_of_Precision_Medicine (JPM) features an article by Jessica Johnson called “Companion Diagnostics – a Burgeoning Market” (1). In this article, Johnson provides a brief account of the recent history of companion diagnostics (CDx) developments and market growth, and mentions the importance of CDx in the ability for ‘niche-busters’ such as trastuzumab and imatinib to hold their market share, despite being marketed to a rather small population. By helping identify the precise patient population most likely to respond to a given drug, CDx enables greater market stability for that drug, and contributes to the marketability of many therapies. In 2006, only five companion diagnostic tests were FDA-approved (1, 2), and all were for cancer therapies. Ten years later, oncology drugs still comprise >40% of all marketed CDx products (2) but the 63 drug-CDx combinations serve a broader range of therapeutic areas, including cardiovascular disease, mental illness and infectious disease. See here for a complete list of FDA-cleared or approved CDx devices.
The article highlights that there is still a lot of work to do regarding the development of new companion diagnostic tests, and mentions some platforms which could be instrumental in such developments. One such platform mentioned is QIAGEN’s Modaplex platform. Modaplex is used as a research platform in CDx test development by companies such as Eli Lilly, and enables them to consolidate disparate types of testing onto a single platform. By allowing simultaneous analyses of DNA and RNA biomarkers, Modaplex helps research teams developing CDx tests to more easily identify the potential success or failure of different therapies using a single test, a capability which could positively impact a clinical lab with limited resources and personnel.
Johnson uses the companion diagnostics businesses of QIAGEN and Myriad Genetics as examples of the growing strength of the CDx market. QIAGEN’s Personalized Healthcare/Oncology franchise, which includes its CDx partnering business, leverages multiple technology platforms and sample technologies, a growing menu of CDx assays and a global commercial presence to contribute to the organization’s stability and growth. Platforms such as Modaplex for real-time multiplex PCR and GeneReader for next generation sequencing (NGS) are currently suitable for research use only (RUO), but can also be used for CDx assay development. Other technologies are approved for in vitro diagnostic (IVD) use, such as pyrosequencing (with kits approved for use in Europe) and real-time PCR (with kits approved for use worldwide).
QIAGEN currently has 2 PMA- approved CDx tests for use in tissue: KRAS_(CRC), and EGFR_(NSCLC) . In 2015, QIAGEN announced the CE-IVD marking of its novel liquid biopsy-based companion diagnostic (3), the therascreen_EGFR_Plasma_RGQ_PCR_Kit to assess EGFR mutations from circulating DNA (cfDNA) in patients with non-small cell lung cancer (NSCLC).
QIAGEN plans to register and submit more companion diagnostics tests for regulatory approval, such as CE-IVD of the therascreen ALK RGQ RT- PCR kit for use in Europe. This test detects anaplastic lymphoma kinase (ALK) fusion gene expression, which can help determine whether treatment with ALK tyrosine kinase inhibitors (TKIs) such as crizotinib and ceritinib may be beneficial (6). QIAGEN also has a companion diagnostic assay in development to detect alterations in mesenchymal-epithelial transition factor proto-oncogene (MET), which accompanies Mirati Therapeutic’s MET inhibitor glesatinib, now in Phase II trials (find out more here).
Johnson concludes that the companion diagnostics market is unlikely to falter anytime soon, stating as evidence the nearly 100 drugs in phase II, III and IV clinical trials with CDx tests listed as potentially integral to their prescription and labeling. Despite no guarantee that all of these drugs and CDx tests will make it to market, drug developers who can identify patient segments in which their drug is more likely to be efficacious, or which have an increased risk for adverse events or non-responsiveness, have higher chances of obtaining regulatory approval. Companion diagnostics is one of the few tools available to drug developers that can generate this information.
While companion diagnostics holds the promise of improving the predictability of the drug development process, CDx also benefits patients, healthcare providers and health systems (4, 5). Companion diagnostics provides extremely valuable information which allows patients and health practitioners to decide, with a higher level of certainty, the potential benefits of a treatment or care pathway. This can result in less time and money spent on treatment plans which don’t work. Patients who test positively to receive a targeted therapy are often in a more positive emotional state, gaining hope of a longer and higher quality of life. Fundamentally, personalized healthcare and companion diagnostics have the power to ‘give each patient hope for a better life by ensuring they receive the best individualized care’.
All of these benefits of companion diagnostics are what QIAGEN is dedicated to, and invested in delivering. QIAGEN continues to expand its portfolio of Sample to Insight technologies for oncology through collaborations with pharma partners to help them identify the right treatment for the right patient. QIAGEN is ideally positioned to provide comprehensive, customized programs for co-development of individual companion diagnostics. Find out more about QIAGEN’s partnerships and oncology companion diagnostics solutions in the US and oncology solutions available throughout Europe.
- 1. Johnson, JP. (2016) Companion Diagnostics – a Burgeoning Market. The Journal of Precision Medicine 07/16:12–13. (Link)
- 2. Agarwal, A., Ressler, D. and Snyde G. (2015) The current and future state of companion diagnostics. Pharmgenomics Pers Med. 8: 99–110. (Link)
- 3. Press release PR newswire Jan 12, 2015: QIAGEN Announces First-ever Regulatory Registration of a Lung Cancer Companion Diagnostic Based on Liquid Biopsies. (Link)
- 4. Wurcel, V., et al. (2016) The Value of Companion Diagnostics: Overcoming Access Barriers to Transform Personalised Health Care into an Affordable Reality in Europe. Public Health Genomics 19(3):137–143. (Link)
- 5. Olsen, D. and Jørgensen, J.T. (2014) Companion Diagnostics for Targeted Cancer Drugs – Clinical and Regulatory Aspects. Front Oncol. 4(105): 1–8. (Link)
- 6. Besse, B. et al. (2014) 2nd ESMO Consensus Conference on Lung Cancer: non-small-cell lung cancer first-line/second and further lines of treatment in advanced disease. Annals of Oncology 25: 1475–1484. (Link)