BD New Flow Cytometer System FDA Cleared

BD announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a flow cytometer system with a leucocount reagent assay used in residual white blood cell enumeration.

When used together with the BD Leucocount™ kit and BD Trucount™ tubes, the new BD FACSVia™ system provides a simple solution for identifying and counting rWBCs in leucoreduced blood products.

“The BD FACSVia system provides blood banks and clinical laboratories with an easy-to-use cell analysis solution to help determine and quantify the presence of residual white blood cells in their blood products,” said John Ledek, president of Biosciences for BD. “The addition of the BD FACSVia system follows our larger strategy of making flow cytometry easier to use with improved efficiency, simplified sample analysis and high-quality diagnostic results.”

With an intuitive user interface, the fully automated BD FACSVia system improves overall lab efficiency and simplifies workflow.

The BD FACSVia system offers the performance of a full-function clinical flow cytometer but in a compact design that easily fits on a benchtop or within a hood.

ITL to develop ground-breaking cancer imaging project

Innovative medical device contractor ITL Group has partnered with King’s College London (KCL) to develop a ground-breaking cancer imaging project.

The project, funded by the EU Horizon 2020 scheme, brings a consortium of 20 companies, including technology giants Phillips and Siemens, to exploit developments in engineering and Magnetic Resonance Imaging (MRI) to develop Magnetic Resonance Force Imaging (MRFI) for new applications in cancer diagnostics.

The project aims to address a fundamental need in planning and monitoring of cancer treatment by allowing better identification and sizing of cancer tumours.

ITL Group joined the consortium in 2015 as a medical device design, development and manufacturing partner, becoming active in 2017 once earlier elements of the project had been completed.

Re-imagining MRI for new applications could provide a non-invasive way to diagnose and measure cancer tumours. This project will produce three prototypes developed for use on brain, liver and breast cancer patients.

Picture: ITL Group

ITL Group, with 40 years of industry experience, will further develop KCL’s initial hardware design, and manufacture several prototypes, which will be presented to Harvard Medical School this summer. The hardware is an advanced vibration transducer which functions by measuring interstitial fluid pressure and cell traction forces.

The global company, with operations in UK, US and China, has taken the original three vibration transducers through a rigorous development process to improve on the initial concept.

King’s provided ITL with an initial design and brief; to make the device smaller and more compact, more aesthetically pleasing, easier to handle and with improved performance and efficiency.

ITL has made significant headway in improving the technology that can guide treatment choices in breast, liver and brain cancer patients, with prototypes ready for trials in June 2017.

ITL Mechanical Engineer, Dan Hollands, is leading the project, taking dual roles as Project Manager and Head Engineer.

For the project, ITL has been trialling a state-of-the-art 3D printer to open up the possibilities of development and experimentation. As the transducer will be used in a MRI scanner it’s necessary that all components are plastic, therefore it lends itself to the 3D printing process.

Unlike commercial projects ITL has completed over the past 40 years, this grant gives ITL free reign to experiment and innovate. Essentially the design and development process can continue to the capacity of the grant – giving Dan Hollands time to push the design to its limits.

Over the year’s ITL has collaborated with a host of leading universities in the UK.

Source: ITL Group

Non-invasive prostate cancer diagnosing and monitoring

Photo: Washington State University

Technology being developed at Washington State University provides a non-invasive approach for diagnosing prostate cancer and tracking the disease’s progression.

The innovative filter-like device isolates prostate cancer indicators from other cellular information in blood and urine. It could enable doctors to determine how cancer patients are responding to different treatments without needing to perform invasive biopsies.

Guidance for effective treatment

The WSU research team fitted a mat of tiny glass springs with specially designed biomarkers that attract the fatty droplets of proteins and RNA that tumor cells shed into body fluids. The droplets, called exosomes, contain genetic information that can be analyzed to determine a cancer’s molecular composition, even how far it has advanced.

“It may be possible to predict which drugs would be most effective in treating a patient’s cancer,” said WSU chemistry professor Clifford Berkman, who led the design of the biomarkers. “More broadly, this technology could be expanded to other types of cancers and diseases.”

Writing in Springer’s Journal of Materials Science, Berkman, Parissa Ziaei, a Ph.D. student in the interdisciplinary materials science and engineering program, and Grant Norton, professor of mechanical and materials engineering, said their capture technique is more efficient than previous approaches at isolating prostate tumor exosomes from other bits and pieces of cellular information.

The researchers are working on designs for a version of their filter-like device for use in a clinical setting.

A non-invasive alternative to biopsy

Prostate cancer can be a serious disease, but most men diagnosed with prostate cancer do not die from it. In fact, more than 2.9 million men in the United States who have been diagnosed with prostate cancer at some point are still alive today, according to the American Cancer Society.

The fact that prostate cancer can remain in a human for years before spreading to other organs makes monitoring its progression and response to treatment an important, long-term process.

A biopsy, a procedure in which small samples of the prostate are removed with a needle, is sometimes performed on a patient if blood tests reveal abnormalities that indicate the presence of prostate cancer. Biopsies are also performed to track the progression of the disease and how it is responding to treatment. The biopsy is generally safe but sometimes leads to bleeding or infection.

The WSU exosome capture technique could provide a reliable and non-invasive alternative to biopsy.

“Say you have a urine sample from a patient known to have prostate cancer. You could pass the urine through the device we are in the process of putting together and measure the number of exosomes that are specifically from prostate cancer cells,” Norton said. “The physician would propose a treatment plan and the amount of exosomes in a follow-up urine sample would indicate how effective the treatment was.”

Possibilities for detecting other cancers

In addition to helping doctors monitor the progression of prostate cancer, the WSU researchers hope their new approach can be applied to help treat patients with other forms of cancer and disease. The filter-like mat of glass nanosprings synthesized in Norton’s lab could feasibly be fitted with a wide array of biomarkers to attract cancer exosomes in urine, blood and other bodily fluids.

“It wouldn’t be a big step to imagine applying what we are doing now to breast cancer or pancreatic cancer,” Norton said. “It opens up all kinds of exciting possibilities.”

The research supports WSU’s Grand Challenges – initiatives aimed at particularly pressing societal concerns. It is particularly relevant to the challenge of sustaining health and changing the course of disease.

Source: Washington State University

Velano Needle-Free Blood Draw Technology FDA Approved

Photo: Velano Vascular

Medical device innovator Velano Vascular announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for PIVO™, its innovative needle-free vascular access device that seeks to improve the blood draw experience for patients while reducing risk to both patients and practitioners. Based on significant usage and input from practitioners, the new, improved device is designed for ease-of-use and high volume manufacturing.

“The deliberate and thoughtful design inputs for the next generation of PIVO reflect our commitment to rapid product development cycles informed by real world experience in the country’s leading health systems,” said Velano Vascular Chief Executive Eric M. Stone. “Feedback from hundreds of practitioners already using our technology reinforced PIVO’s ability to enhance the blood draw experience for patients and clinical staff, and helped us to develop a next generation product better suited for widespread adoption.”

PIVO is a single-use, disposable device that enables consistent, high quality blood samples from indwelling peripheral IV lines, allowing hospitals to reduce reliance on repeated needle sticks and central line access for blood collection. In addition to seeking a more compassionate care experience for patients, a safer environment for practitioners, and a more financially responsible alternative for health systems, PIVO aims to equip hospitals to better serve the increasing population of DVA (Difficult Venous Access) patients.

“Our experience with PIVO illuminates that blood draws can be a painless, lower risk experience for patients and practitioners,” explained Sutter Health Chief Nurse Officer Anna Kiger, DNP, D.Sc., MBA, R.N. “By further improving the usability and accessibility of this innovation, the potential exists for a global standard of more compassionate care.”

PIVO is currently in use at multiple health systems nationwide and will be available more broadly in 2017 following this FDA-clearance for the second generation PIVO solution. Frost & Sullivan awarded PIVO its New Product Innovation Award for Vascular Access in 2016.

Source: Velano Vascular

FDA approves AI powered Automated Plate Assessment System

Clever Culture Systems AG (CCS), the Swiss based joint venture between Australian medical technology company LBT Innovations Limited and Hettich AG (Switzerland) has received clearance of its 510(k) de novo submission to the US Food and Drug Administration (FDA) for APAS® as a Class II medical device.

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Celgene and Agios Announce Collaborations with Abbott for Diagnostic Identification of IDH Mutations in AML

Celgene Corporation and Agios Pharmaceuticals, Inc. announced each company has entered into collaboration agreements with Abbott to develop and commercialize companion diagnostic tests on Abbott’s m2000 RealTime System to identify isocitrate dehydrogenase (IDH) mutations in acute myeloid leukemia (AML) patients. Celgene is currently developing enasidenib (AG-221/CC-90007), an IDH2 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH2 mutation. Agios is developing AG-120, an IDH1 mutant inhibitor, for the treatment of patients with relapsed or refractory AML who have an IDH1 mutation.

IDH1 and IDH2 mutations occur in approximately 20% of AML patients. An article published online this week in the journal Leukemia (Medeiros, Leukemia 2016) concluded that advances in the understanding of the genetics underlying myeloid malignancies are driving an era of development for targeted treatments such as IDH mutant inhibitors. The authors recommend that IDH mutational analysis should become part of the routine AML diagnostic workup and repeated at relapse to identify patients who may be eligible for targeted investigational treatments currently under clinical study.

“AML is a complex and heterogeneous disease, making it difficult to treat,” said Han Myint, M.D., Vice President, Global Medical Affairs, Myeloid for Celgene. “IDH mutations lead to aberrant DNA methylation, causing a block in myeloid differentiation that leads to disease progression. Molecular profiling is important to identify genomic mutations which may have prognostic and potential treatment implications for patients with AML.”

Abbott’s m2000rt RealTime System, is a polymerase chain reaction (PCR) instrument designed to enable clinical laboratories to automate PCR and results analysis, simplifying the complex and manual steps often associated with molecular diagnostics. Both Celgene and Agios have incorporated this screening into clinical trial designs, including the recently initiated Phase 3 IDHENTIFY trial comparing enasidenib with conventional therapy in older patients with an IDH2 mutation and relapsed or refractory AML (NCT02577406).

“The field of personalized medicine is advancing at a rapid pace for a broad range of medical conditions, especially within hematology-oncology,” said Chris Bowden, M.D., chief medical officer at Agios. “Our collaboration with Abbott will provide a test to help identify AML patients with IDH mutations who are in need of treatment options.”

The m2000 system has not been FDA cleared or approved for use with enasidenib or AG-120.

Enasidenib and AG-120 have not been approved for any use in any country.

Source: Agios Pharmaceuticals