CLN Article

Industry Playbook

Pancreatic cancer tumor

OHSU, Immunovia Partner to Validate Early Detection Test for Pancreatic Cancer

The Knight Cancer Institute at Oregon Health and Science University (OHSU) and Swedish company Immunovia have teamed to confirm, validate, and commercialize a blood test developed by Immunovia for the early diagnosis of pancreatic cancer. Called IMMray PanCan-d, the test analyzes a patient’s immune system for early signs of disease. The collaboration will also enable researchers to explore biomarkers for a number of other cancer types.

Given that pancreatic cancer patients rarely exhibit symptoms until the disease has progressed, screening tests are needed to find tumors in their initial stages, when removing them surgically has the best chance of improving prognosis. However, screening tests that look for single biological markers of the disease are ineffective because they don’t discriminate between pancreatic cancer and less deadly conditions such as chronic pancreatitis, liver cirrhosis, and other gastrointestinal cancers. In contrast, Immunovia’s test platform creates a biological snapshot of an individual’s immune-response by analyzing serum proteins that change as a sign of disease.

“If we’re going to make a significant impact on patients’ lives and improve their chances of survival, we need to detect cancer earlier when it’s most treatable,” said Brian Druker, MD, director of the OHSU Knight Cancer Institute. “The immune system provides an early warning system that is invaluable in that effort.”

OHSU’s scientists will conduct a retrospective clinical validation study to help confirm the analytes used by IMMray PanCan-d and verify the findings of previous studies from Europe and China examining the test’s performance. OHSU’s study will use about 600 samples collected from consenting patients with different stages of pancreatic cancer and matched controls, as well as from patients with chronic pancreatitis. After the test has been confirmed, the OHSU Knight Diagnostic Laboratories will then validate the test for clinical application.

Chembio Wins Grant to Develop POC Multiplex Test for Dangerous Febrile Illnesses

The Paul G. Allen Ebola Program has awarded Chembio Diagnostics a 12-month, $2.1 million grant to develop a point-of-care (POC) multiplex test to detect malaria, dengue, Ebola, Lassa, Marburg, and chikungunya. Currently available POC diagnostics for these febrile illnesses lack the ability to test for multiple diseases at once. Chembio’s fever panel will use the company’s patented dual path platform, and will include a quality control test band and seven test bands with specific antibodies to detect different pathogens, including multiple serotypes of the same pathogen. “A small, cost-effective, battery-operated digital reader will be used to read the test results and report them electronically,” said Javan Esfandiari, chief science and technology officer of Chembio. “We believe the DPP Fever Panel assay and reader will become important tools in the battle against emerging disease worldwide.”

Siemens Joins Consortium to Establish the Clinical Utility of Liquid Biopsies

Siemens Healthcare has become a member of the Cancer-ID consortium, a project of the European Union’s Innovative Medicines Initiative, to explore the potential of blood-based biomarkers for the detection and treatment of cancer. This consortium currently includes 33 partners from 13 countries working together to establish standard protocols for the clinical validation of blood-based biomarkers such as circulating tumor cells. These partners include experts from academic and clinical research, diagnostic companies such as Siemens, and members of the pharmaceutical industry. “The Cancer-ID fills the substantial gap between basic research focused on novel methods for the detection and characterization of circulating tumor cells and nucleic acids and the development of robust, validated assays required to bring the liquid biopsy into the clinic,” said Klaus Pantel, MD, head of the Department of Tumor Biology at the University Medical Center Hamburg-Eppendorf and one of the academic leads for the consortium.

Symbiodx, Cure Forward to Enhance Patient Access to Genomic Data

Symbiodx, a molecular reference lab in Seattle, and Cure Forward, a multi-sided technology platform to support patient engagement, have entered a partnership to advance precision medicine. This collaboration will provide patients with streamlined access to their genomic data and greater exposure to relevant clinical trials. Symbiodx offers a novel solution for cancer genomics testing through a custom designed next-generation sequencing assay that incorporates histopathology findings, and informs clinical decision-making for both solid and hematologic malignancies. Through Cure Forward’s website, patients can then retrieve molecular diagnostic test results ordered by their physicians from accredited laboratory test providers, and use that data to investigate treatment options including clinical trials.

In addition to the clinical trial exchange, Cure Forward also offers access to educational information to help consumers understand the molecular science of their disease, as well as an online community where patients with the same molecular and clinical factors can connect and collaborate.

Curetis, Acumen Collaborate on Sepsis Test, Sign Distribution Agreement

German company Curetis has obtained a worldwide, non-exclusive license to AcuSept, a proprietary biomarker panel from Singapore-based Acumen Research Laboratories. The panel is in advanced clinical development and will be used by Curetis and Acumen for the joint development and clinical validation of a sepsis host response test on Curetis’s Unyvero Platform. The AcuSept biomarker panel detects changes in a patient’s immune system that are indicative of pathogens in the bloodstream and of systemic inflammatory response syndrome (SIRS) caused by these microorganisms. The ability to make a fast and clear distinction between patients with sepsis and those who only have either infections or SIRS is key to getting patients effective treatment and improving their chances of survival.

Separately, Curetis and Acumen have also signed an exclusive, multi-year distribution agreement for the Unyvero product line in the Southeast Asian market, which will initially include Singapore, Malaysia, Thailand, and Indonesia.

Pressure BioSciences, FIU Join Forces to Improve Rape Kit Test Methods

Pressure BioSciences has entered an agreement with Florida International University (FIU) to develop a rape kit test method using Pressure BioSciences’ pressure cycling technology (PCT)-based sample preparation solutions. Currently, the standard practice for rape kits is to collect biological samples on cotton swabs for forensic analysis. However, isolating high quality DNA from these swabs is difficult, as the biological sample is often trapped in the cotton fibers, resulting in a loss of evidence. 

Recently, researchers from FIU published a study showing that a novel, PCT-based technique increases DNA yields from cotton swabs while also decreasing processing times and using inexpensive reagents on a semi-automated platform. “We are excited by this opportunity to expand the range of applications of PCT… specifically to assist in the development of a rapid and direct alternative to current methods for the analysis of rape kits,” said Bruce McCord, PhD, associate director of FIU’s International Forensic Research Institute.

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