By Ben Butkus
Swiss molecular diagnostics shop Diagnoplex this week received a boost toward commercializing its flagship PCR-based colon cancer blood test in the form of a "substantial" Series A financing extension by fellow Swiss biopharmaceutical conglomerate Debiopharm Group.
Diagnoplex will use the cash influx primarily to complete a 1,400-patient clinical trial of its test, called Colox, which the company launched after closing a CHF 10 million ($8.3 million at the time) Series A financing round in late 2008. The company said that it hopes to provide interim results from the trial by the middle of this year.
Although Diagnoplex and its newest investor Debiopharm did not disclose the amount of the add-on investment, they said that Debiopharm has committed to provide half of its investment up front with the rest subject to the completion of certain undisclosed milestones.
Investors in the original CHF 10 million Series A included Novartis Venture Fund, NeoMed, and Initiative Capital Romandie. The Novartis Venture Fund also provided seed funding to Diagnoplex.
The Colox test is currently based on single-channel quantitative multiplex RT-PCR technology developed by Diagnoplex founder and CEO Stavros Therianos during his tenure at the University of Rochester.
According to Diagnoplex, the platform allows the quantification of up to 60 genes simultaneously and combines some of the advantages of quantitative PCR, such as a high degree of accuracy and reliability, with the ability to analyze multi-gene signatures of different cancers.
"Unlike other PCR-based approaches to blood-based cancer screening, [which] focus on methylation [or] mutations arising from the developing tumor and released in the blood stream, Diagnoplex focuses on the so-called hot response, occurring at very early stages of tumor formation," Maurice Wagner, director of corporate affairs and communications at Debiopharm, told PCR Insider this week.
"The first advantage, therefore, lies in the fact that host-tumor interactions already occur at earliest stages of the tumor progression," Wagner added. "Another advantage is that the PCR methodology used allows a significantly shorter time to result compared to methylation approaches — such as bisulfite treatment — in a more routine setting for clinical laboratories."
Another of the platform's strengths is the fact that unlike most multiplex PCR methods, the number of genes that can be quantified in parallel using the Diagnoplex approach is not limited by the number of fluorescence channels available on a PCR instrument. As such, the test should be platform-agnostic.
Diagnoplex has not yet settled on the final number of biomarkers it will use for the Colox test, which is designed to be a non-invasive blood-based test for the early detection of colon cancer.
Wagner said that the final number of biomarkers used will determine whether the single-channel quantitative multiplex RT-PCR technology will be used in the final commercial product, suggesting that Diagnoplex may eventually migrate its assay to another nucleic acid amplification and detection technology.
In addition, "different technologies may be considered for future licensing if they meet the Colox requirements and the business strategy," Wagner said.
Diagnoplex is currently conducting a clinical validation study of Colox in 1,400 individuals at nine centers in Switzerland, Germany, and South Korea. Although it hopes to present interim results in mid-2011, Diagnoplex said that early results from a training set of 140 individuals showed that Colox can detect adenomatous polyps, which represent the pre-cancerous stage of colon cancer.
Like others developing blood-based molecular tests for colon cancer, such as Exact Sciences, Genomic Health, Agendia, Epigenomics, Enzo, and GeneNews, Diagnoplex is hoping that its test can provide early detection of the disease with subsequent intervention by colonoscopy. Multiple studies have demonstrated that colon cancer survival rates improve by up to 90 percent when the disease is detected early.
In Debiopharm, Diagnoplex gets a potential commercialization partner with a broad network of biopharmaceutical industry ties and experience in licensing, developing, or co-developing products for eventual outlicensing to pharmaceutical companies for sales and marketing.
Based in Lausanne, Debiopharm's goal "is to contribute to an effort which can lead to a significantly more efficient use of public spending for health-related issues" such as earlier disease detection and earlier and therefore less costly treatment, Wagner said, particularly with severe diseases like colorectal cancer.
"Through its existing diagnostic investments and drug-development expertise it will support Diagnoplex in obtaining the best possible results with Colox," he added.
In April, Debiopharm participated in a €30 million ($41.3 million) Series B financing round for fledgling molecular diagnostics firm Biocartis, which is developing an automated molecular diagnostics platform based on proprietary nucleic acid sample prep technology acquired from Royal Philips Electronics (PCR Insider, 4/8/2010).
As part of that investment, Debiopharm said that it would help Biocartis create companion diagnostics for therapies developed by Debiopharm in the areas of oncology and infectious diseases, with Debiopharm contributing biomarker expertise.
Last week, after Biocartis announced a strategic agreement with Janssen Pharmaceutica to co-develop molecular diagnostic assays on its platform, a company executive noted that Biocartis had not yet chosen a specific PCR detection chemistry for its platform.
When asked about the potential for collaboration between the Debiopharm portfolio companies, Wagner noted that Biocartis has "a very attractive and promising diagnostic platform that can change the landscape on how molecular diagnostic will be performed in the near future.
"With Colox, Diagnoplex has a very attractive content and testing approach for colorectal cancer," Wagner added. "Any type of collaboration may therefore well suit both companies' interests. It is, however, a decision that all investors and the respective companies will need to explore and align with their respective strategic plans."
Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.