Companion Diagnostics Evolve

Print 19 January 2016
Chelsea Lacey-Mabe / Advanced healthcare Network

Out of seven billion people on this earth, no two people are the same. Companion diagnostics (CDx) providers argue their medicines shouldn't be the same either. In a world where someone can customize their sandwich, sneakers and even their physical appearance, the healthcare industry has realized one-size-fits-all treatments are no longer a good fit.

CDx has been around since the 1980s, with some of the first major successes found in chemotherapy drugs like Imatinib to treat leukemia and Trastuzumab to treat breast, esophageal and stomach cancers. By 2006, three more drugs had joined the ranks, gaining FDA approval, and by 2012, the number of combinations of companion diagnostics with corresponding drugs had increased to 63.¹ Despite the constantly evolving healthcare system, CDx is proving to have staying power. Diagnostic companies today are doing what it takes to survive in the market and help complete the transition to more personalized medicines.

For example, Epic Sciences, a privately held biotech company invested in a CLIA/CAP-certified laboratory and runs immunofluorescence assays on a blood sample to detect specific circulating tumor cells (CTCs) and relevant immune cells.

"Staying abreast with the latest advances in oncology requires being active with cutting-edge research and collaborating with key leaders in the field," said Chris Bernard, chief commercial officer at Epic Sciences. "We've accomplished this by integrating Epic Sciences' CTC technology in a number of clinical trials with 35 biotech and pharmaceutical companies. We also work with prominent academic and medical institutions, to investigate how cancer heterogeneity affects existing therapies and potential novel drugs."

Bernard explained that their "no cell left behind" technology is able to detect CTCs and characterize them by analyzing a regular blood draw from a patient. 

Common limitations for lab companies are that the diagnostic assays often have a narrow scope and one single test gives little information of the location of the target biomarkers. As a result, multiple tests are sometimes necessary in order to predict drug efficacy and assess for potential resistance, adding waste to their lab process.²

Instead of a limited view of underlying cellular heterogeneity that drives cancer though, Epic's unbiased view allows a more complete characterization of the complete tumor cell population over time and in response to successive rounds of therapy.

Other labs are analyzing their processes for potential improvement areas as a way to have an edge over other competition in this expanding market. Some are following suit of more industrial companies who use improvement strategies like Lean and Six Sigma to develop better business practices. Quest Diagnostics, for example, has implemented Six Sigma since 2000 according to their website.³ More recently they introduced Lean to focus on improving the flow and speed of their procedures and to reduce waste or anything that doesn't bring value to a process including added time.

Many labs today are also becoming more efficient by implementing practices that allow them to easily pull an already-collected and subsequently tested sample to run additional testing. North Memorial Health Care in Minnesota is a hospital-based lab that streamlines this operation with the help of the Aptio automation system by Siemens. The equipment allows them to auto-receive samples, has eliminated their work spaces and helped to grow their outreach by 12%.⁴

"Diagnostic tests today discard parts of a sample and prevent such unbiased retrospective analysis," explained Bernard. "Since [Epic Sciences] preserves these cells without a priori selection criteria or bias, partners can investigate a wide variety of biological questions, even for cell types and targets that were not known to science when the patient sample was obtained. This will have a transformative impact on drug development programs and the utility of clinical trials."

The number of partnerships and collaborations Epic has had, the most recent being with ESSA, shows they have a hold in the market. It seems pharmaceutical companies and diagnostic labs are announcing new collaborations every day, showing the strong competition between both drug companies-to develop new medicines-and diagnostic companies-to develop new tests.

This competition spurs pharma and diagnostic companies to develop new procedures, update their equipment., and improve upon their techniques, but ultimately, patients will benefit from the pressure to be more innovative than the next.

References:

1. Agarwal, A, et al. The current and future state of companion diagnostics. Pharmgenomics Pers Med. March 2015;8:99-110. doi: 10.2147/PGPM.S49493.

2. Van Heertum, R, et al. Companion diagnostics and molecular imaging-enhanced approaches for oncology clinical trials. Drug Des Devel Ther. Sep. 2015; 9:5215-5223. doi:10.2147/DDDT.S87561.

3. Quest Diagnostics. What is Six Sigma Quality at Quest Diagnostics. http://tinyurl.com/zjyzyln.

4. Siemens. Aptio Automation. http://tinyurl.com/j7e47lt.

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