CLN Article

Industry Playbook

West African Outbreak Spurs Development of Rapid Ebola Tests 

Worldwide efforts have increased to develop rapid point-of-care Ebola tests as the deadly outbreak in West Africa has brought this disease to the forefront of international consciousness. Most recently, Luminex Corporation announced that the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Diagnostics Division is developing rapid diagnostics for the Ebola virus using Luminex’s xMAP technology. Other organizations working to develop similar tests include Corgenix Medical Corporation and Uganda’s Makerere University.

Because there is currently no vaccine or cure for Ebola, quickly identifying infected patients is crucial to treating and stopping the spread of the disease. However, Ebola is difficult to diagnose because many of its early signs and symptoms resemble those of other infectious diseases such as typhoid and malaria. Current testing for the Ebola virus also requires biohazard handling, with test samples traveling long distances to special labs—a process that can delay diagnoses by several days.

The tests being developed by USAMRIID’s Diagnostics Division, Corgenix, and Makerere University could help to combat future outbreaks by detecting Ebola in minutes at the point-of-care. USAMRIID’s assays run on Luminex’s xMAP-based MAGPIX multi-analyte detection platform and use serum samples to detect the presence of viral antigens as well as Ebola antibodies. The latter provides information about the immune response of the host, which could aid in the development of treatments for the disease.

In June, the National Institutes of Health also awarded Corgenix a 3-year, $2.9 million grant to advance the development of a rapid, portable Ebola test kit. This test detects Ebola in human blood in 10 minutes using lateral flow immunoassay technology, which enables test results to be obtained without any instrumentation and read with the naked eye. This means that individuals without extensive medical training could easily perform the test in resource-limited settings. Like Corgenix, Makerere University in Uganda—a country that has experienced several Ebola outbreaks in the past—has also been working on a paper strip test for the disease. Makerere began this project in 2013 with the help of a $95,600 Canadian grant, and is expected to continue work on it through the end of this year. 

Illumina Partners With Pharma Giants to Develop Universal Oncology Co-Diagnostic

Illumina has joined forces with several leading pharmaceutical companies to develop a universal next-generation sequencing (NGS)-based oncology test system. This partnership aims to lead a transition from single-analyte companion diagnostics, in which one drug is paired with one test, to panel-based assays that select for “companion therapeutics,” where numerous drugs are paired with the same test. An estimated 800 oncology drugs are currently in development, many of which are designed to target specific mutations. As new targeted therapies continue to emerge, this universal system could fill the growing need for new co-diagnostic tests.

Illumina’s initial partners include AstraZeneca, Janssen Biotech, and Sanofi. To start, Illumina is developing assays that detect and measure multiple genetic mutations simultaneously to support partners’ clinical trials of targeted cancer therapies, with the eventual goal of developing and commercializing a multi-gene panel for therapeutic selection. In parallel, Illumina is also working with key thought leaders to define regulatory frameworks that would enable this new testing paradigm.

Roche, Garvan Institute Collaborate on Methods to Analyze the Epigenome

Roche and the Garvan Institute of Medical Research have inked a 2-year discovery agreement to develop new technologies for targeted epigenomic analysis using DNA sequencing. The medical community has recently recognized that epigenetic modifications play an important role in a host of biological processes, and researchers have increasingly investigated their role in cancer in particular. Due to the sheer number of epigenomic events responsible for influencing the expression of genes, though, more advanced methods are needed to analyze these myriad changes and further this research. This collaboration aims to leverage the Garvan Institute’s genomics expertise and infrastructure along with the Roche Sequencing Unit’s products for target enrichment to develop new methods to accurately analyze regions of the epigenome. Additionally, scientists at the Garvan Institute will use the SeqCap Target Enrichment System from Roche to advance their research in epigenetic influences on human diseases.

AstraZeneca, Qiagen to Develop Non-Invasive Lung Cancer Co-Diagnostic

AstraZeneca and Qiagen are working to develop a non-invasive­ test to identify non-small cell lung cancer patients who have an epidermal growth factor receptor (EGFR) mutation that makes them suitable for treatment with AstraZeneca’s drug Iressa. Iressa is an EGFR-tyrosine kinase inhibitor that blocks the signals from EGFR that lead to tumor growth. Currently, the main method of assessing EGFR mutation status involves the collection of tumor tissue by needle biopsy or during resection. Qiagen’s test, however, can be performed using a blood sample, and detects EGFR mutations in the small fragments of circulating tumor DNA found in plasma. “Liquid biopsies are an exciting new field in sample technology,” said Peer M. Schatz, CEO of Qiagen. “Our novel solutions for processing tumor DNA and RNA from body fluids are being widely validated for clinical use with existing and new assays and have the potential to improve outcomes for patients for whom invasive surgery is not an option.”

Regulus, Biogen Search for MicroRNA Biomarkers for Multiple Sclerosis

Regulus Therapeutics has entered a collaboration with Biogen Idec to identify microRNA biomarkers in the blood of patients with multiple sclerosis (MS). More than one-third of all human genes are believed to be regulated by micro­RNAs, and studies have shown that microRNA function becomes significantly altered or dysregulated in many disease states. Regulus believes that this makes microRNAs clinically relevant therapeutic targets and suitable biomarkers for diseases like MS. If microRNA biomarkers for MS are found, they might be used to select optimal patient segments in clinical trials, develop companion diagnostics, and monitor disease progression or relapse.

“Utilizing innovative technology such as biomarkers can help us make more informed decisions earlier in clinical development,” said Steven Holtzman, executive vice president of corporate development at Biogen Idec. “We are hopeful it can speed the work we’re doing to bring new, effective treatments to market for patients with MS.”

New Technologies, Emerging Markets Stimulate Diagnostic Market Growth 

In a new report, Kalorama Information estimates that the world market for diagnostics was worth $54.6 billion in 2013, and that it will continue to grow 4% annually, reaching $65 billion by 2018. This includes all laboratory and hospital-based products, as well as over-the-counter product sales.

According to the report, new technology is contributing substantially to the market’s expansion. Diagnostic laboratory technology has changed dramatically in the past few years, due to the publication of the Human Genome Project and advances in functional genomics, bioinformatics, miniaturization, and microelectronics. In turn, this has led major vendors of next-generation­ technologies such as genome sequencing and mass spectrometry to enter the diagnostic market. The report also found that emerging markets have taken off. All of the major diagnostic companies reported, at minimum, a 25% increase in their sales in China, as well as growth in the top seven emerging markets: Brazil, Turkey, Korea, India, Russia, and Mexico.

The full report, “The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition,” is available for purchase,