industry news

Researchers at the University of California San Diego have created a microfluidic device which measures how ‘sticky’ cancer cells are and could improve prognostic evaluation of patient tumours.

The device sorts cells by their physical ability to adhere to their environment inside its microfluidic chamber.

Weakly adherent cells were found to migrate into and invade other tissues more than strongly adherent cells from the same tumour. Genes associated with the weakly adherent cells were also associated with an increased likelihood of a patient’s tumour recurring within five years.

The research has been published in Cancer Research.

Historically it has been difficult to find biological markers to universally identify and select the most aggressive cells in tumours. Now, ‘stickiness’ may provide a physical marker of highly metastatic cells within a heterogeneous tumour cell population.

The microfluidic device uses a coating of adhesive protein to trap cancer cells. The cells are placed in the chamber and after they adhere, fluid is pushed through to detach them. The faster the fluid moves, the higher the shear stress that the cells experience. The research team were able to use this process to isolate cells that detach at specific shear stresses and analyse them.

Cells collected at a lower shear stress were weakly adherent while those collected at higher shear stresses were strongly adherent.

Weakly adherent cells were found to have a unique genetic signature that identifies them and causes them to migrate and invade faster. When compared to patient data in the Cancer Genome Atlas (TCGA) database, researchers found that patients with tumours high in this signature experienced tumour recurrence earlier and more frequently. So far, the research team has tested cells from breast, prostate and lung tumours.

The team hopes that future clinicians will be able to use the device to examine tumour biopsies and estimate the chance of metastasis. This way, they’ll be able to adjust treatment at earlier disease stages to maximise positive clinical outcomes.

The researchers are now looking into ‘priming’ tumours in mice with weakly adherent cells to see if they begin to metastasise earlier and more frequently.

University of California San Diego Comprehensive Breast Health Center director Dr Anne Wallace said: “Many cancers that we see in the clinic, such as ductal carcinoma in situ or DCIS, remain dormant for years. It is nearly impossible for us to predict which fraction of that population will reoccur.”

In cases such as these, the microfluidic device could be the first to address and predict these recurrences.

Quest Diagnostics in the US has signed a multi-year agreement with Siemens Healthineers to procure up to 120 Atellica Solution immunoassay analysers.

With this procurement, Quest seeks to standardise its immunoassay testing across 19 esoteric and core laboratories in the country.

Designed to address common clinical laboratory challenges, Atellica Solution will help Quest Diagnostics in strengthening its immunoassay testing capacity and improving workflow efficiency.

Quest Diagnostics general diagnostics executive vice-president Jim Davis said: “Our strategic relationship with Siemens Healthineers led to the development of a flexible solution that will improve our existing workflow and help us achieve greater cost savings.

“We look forward to implementing this solution throughout our laboratory network.”

As part of the initiative, Atellica Solution immunoassay analysers will also be deployed in a highly automated Quest lab in Clifton, New Jersey.

Atellica will connect to an Inpeco FlexLab automation system to develop a high-throughput, multidisciplinary testing solution to optimise productivity and reduce operational costs.

Once the contract is fully realised, it will be the most extensive deployment of the Atellica Solution to date.

Siemens Healthineers Laboratory Diagnostics president Deepak Nath said: “Siemens Healthineers offers a comprehensive and quality in vitro diagnostics portfolio that is proving to be attractive to leading laboratory providers across the globe.

“Our leadership in workflow and automation is resonating with laboratories worldwide and driving adoption of the Atellica Solution.

“The breadth and depth of our testing solutions, a highly scalable and flexible offering with the Atellica Solution, and a broad immunoassay test menu with proven assay performance, will provide the clinical outcomes Quest Diagnostics requires.”

Clinical diagnostics company Novacyt’s molecular diagnostics division Primerdesign has launched a molecular research use only (RUO) test for novel coronavirus (2019-nCoV).

The company developed the test in response to the recent coronavirus outbreak in China.

Primerdesign’s coronavirus test is capable of detecting only the 2019 strain of the virus.

The company believes that this ability of the test differentiates it from other existing tests, which may also react to other related species giving rise to a false diagnosis.

Additionally, the Primerdesign test is stable at ambient temperatures, eliminating the need for cold chain shipping in tropical climates.

Novacyt CEO Graham Mullis said: “Over the last few days, we have seen significant early demand for our genesig 2019-nCoV test from over ten countries. We believe our assay is the first European test to be made available and will be introduced this weekend at the Medlab Expo in the Middle East.

“Our rapid response to this latest virus outbreak is a testament to our core competency of in-vitro diagnostic design, development, manufacturing and commercialisation.”

Designed to run on multiple molecular testing platforms, including Primerdesign’s own genesig q16 and q32 instrument, the test is for use in large, as well as small laboratories.

It can also generate a result in less time, facilitating the quick screening of samples, which could help stop the spread of the virus unnecessarily.

Chinese authorities identified a new strain of the coronavirus named 2019-nCoV earlier this month. The outbreak, which started in the Chinese city of Wuhan, has also spread to other countries.

Following the outbreak, China and other countries have imposed significant containment controls and people movement restrictions.

The World Health Organization (WHO) has declared the 2019-nCoV outbreak a global emergency as it continues to spread outside of China.

Bright Machines and Diagnostics for the Real World (DRW) have partnered to automate the manufacturing of HIV testing equipment.

DRW’s simple amplification based assay (SAMBA) diagnostic platforms are developed specifically for resource-limited settings and offer point-of-care solutions to test patients’ blood for the presence of HIV. The toaster-sized devices use a small volume of blood from a finger or heel prick and can provide a diagnosis.

The company will now use a Bright Machines Microfactory to automate the manufacturing of the test cartridges used in its SAMBA II diagnostic device.

The partnership will enable DRW to free its team from the repetitive, labour-intensive product assembly and inspection process, reducing assembly labour costs by 75%. The company said it plans to increase its output of the cartridges tenfold to over one million units a year, as automated production reduces assembly time from two minutes to just 20 seconds per unit.

DRW founder and CEO Dr Helen Lee said: “Our devices impact the lives of hundreds of thousands of people who otherwise wouldn’t have access to centralised testing. Bright Machines is helping us quickly scale our production capacity to make our products even more accessible to remote areas.”

Bright Machines’ software-defined manufacturing connects individual machines to an automated software layer to configure, monitor and manage operations. The robotic systems take advantage of machine learning and computer vision to deliver an efficient assembly process.

Clinics using DRW’s SAMBA devices rely on the affordability and availability of test cartridges to ensure fast, accurate diagnosis and disease management. Using Bright Machines’ Microfactory will allow DRW to better serve its existing customer base and broaden its reach to resource-limited settings where access to advanced medical care is both limited and expensive.

Bright Machines CEO Amar Hanspal said: “At Bright Machines, solving big, real-world problems is core to our mission. We admire Diagnostics for the Real World for the important work they’re doing, and we’re proud to partner with them in their mission to scale their groundbreaking HIV testing technology to areas of the world that need it most.”

BioIntelliSense has received 510(k) approval from the US Food and Drug Administration (FDA) for its BioSticker on-body sensor for scalable remote care.

BioSticker is an on-body sensor that enables constant monitoring of critical signs and actionable insights of patients.

The platform assists doctors to access data from patients in the home setting, leading to early detection of potentially avoidable complications.

BioIntelliSense has also commercially launched its medical-grade Data-as-a-Service (DaaS) platform in the US.

DaaS platform captures vital signs every minute, as well as physiological biometrics and symptomatic events, providing an effortless experience for patients.

With the help of the platform’s advanced analytics, doctors can generate high-resolution patient trending and reporting to provide medical-grade care at homes.

BioIntelliSense CEO Dr James Mault said: “We are at the inception of a remarkable new era in healthcare that will employ medical-grade sensor technologies to effortlessly capture remote patient data and generate personalised clinical intelligence.”

BioIntelliSense has entered into a strategic partnership with UCHealth and its CARE Innovation Center to show the clinical applications of the BioSticker device and medical-grade services.

The partnership aims to build and validate models of data-driven care, patient-centred and designed for scale.

UCHealth chief innovation officer Dr Richard Zane said: “The use of the BioSticker device for continuous health monitoring enables us to monitor a patient in their home and recognize when a patient may have an exacerbation of illness even before they manifest symptoms.

“This may reduce hospitalisations, emergency department visits and shorten hospital stays, creating cost efficiencies for health systems.”

Last July, Fresenius Medical Care North America invested in BioIntelliSense, which is working on a medical-grade data services platform for continuous, remote patient monitoring.

Brain tumour therapy company GT Medical Technologies has received US Food and Drug Administration (FDA) clearance for an expanded indication of its GammaTile therapy.

Previously reserved for patients with recurrent brain tumours, patients with newly diagnosed malignant brain tumours are now eligible to receive its surgically targeted radiation therapy (STaRT).

The device, which features a bioresorbable collagen tile with embedded radiation seeds, is designed specifically for use in the brain and offers advantages for patients undergoing surgery for brain tumours. GammaTile is designed to be implanted in the head after surgery to delay regrowth by immediately delivering radiation to the site from which the tumour was removed.

This means patients are able to target residual tumour cells immediately, rather than wait several weeks for surgical wounds to heal before beginning treatment. There is no need for them to visit a clinic to undergo a radiotherapy session, as the device delivering the therapy is already implanted.

GammaTile radiation therapy became available to patients with recurrent brain tumours in January 2019, and is the most recent treatment cleared or approved by the FDA for brain tumours.

GT Medical Technologies president and CEO Matthew Likens said: “We are pleased to offer GammaTile Therapy to patients who are newly diagnosed with malignant brain tumours, in addition to patients with recurrent brain tumours.

“This is a significant step forward that expands our ability to improve the lives of patients with brain tumours. Patients receiving GammaTile Therapy immediately after the removal of a brain tumour will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumour cells where treatment is most needed to help prevent recurrence.”

In a clinical study, data from which was presented at the 2019 Society of Neuro-Oncology Annual Meeting, local control of tumour growth was achieved in approximately 90% of patients who were implanted with a GammaTile after gross total resection.

University of Minnesota Medical School Department of Neurosurgery head Dr Clark Chen said: “GammaTile Therapy is an important addition to the armamentarium of treatments available against brain cancer. It has the potential to improve the quality of life as well as clinical outcome. I am encouraged by the FDA’s decision to expand the indications for this therapy.”