Industry news
WHO and MPP enter worldwide licencing deal for Covid-19 antibody test
24 November | Licencing
The Covid-19 Technology Access Pool (C-TAP) of the World Health Organization (WHO) and the Medicines Patent Pool (MPP) have finalised a worldwide, non-exclusive licencing agreement with the Spanish National Research Council (CSIC) for its Covid-19 serological antibody test.
The test can detect the presence of anti-Covid-19 antibodies generated in response to either a SARS-CoV-2 infection or vaccination.
The non-exclusive licensing agreement is the first-ever test licence to be signed by the MPP. All associated patents, as well as the biological material required for the test’s production, are included in the deal.
The CSIC will extend complete expertise and training to MPP and/or other potential licensees. For low- and middle-income nations, the licence will be offered on a royalty-free basis and remain valid until the final patent expires.
29 November | Diagnostics
OPTELLUM AND GE HEALTHCARE TO ADVANCE AI-POWERED LUNG CANCER DIAGNOSIS
Optellum and GE Healthcare intend to work together to advance the diagnosis of lung cancer with artificial intelligence (AI).
The collaboration aims to help healthcare providers determine the malignancy of lung nodules that are difficult to diagnose, enabling them to expedite subsequent treatment.
Optellum stated that its AI-powered software, Virtual Nodule Clinic, helps to identify and score the malignancy probability of a lung nodule. It can enhance the specificity and sensitivity of indeterminate nodule malignancy assessments.
It is claimed to be the only AI-assisted diagnosis software approved by the US Food and Drug Administration (FDA) for early-stage lung cancer.
29 November | Imaging
SUBTLE MEDICAL PARTNERS WITH BAYER TO APPLY AI IN MEDICAL IMAGING
Subtle Medical is collaborating with Bayer to explore opportunities for using AI in medical imaging.
The companies will assess the potential of Subtle Medical’s investigational AI algorithm, named SubtleGAD, to improve image qualities in contrast-enhanced magnetic resonance imaging (MRI) exams.
The AI-powered software leverages deep learning technology to achieve a 90% dose reduction of Gadolinium-based contrast agents for contrast-enhanced MRI exams. The software helps to deliver improved image quality and support lesion detectability.
Subtle Medical stated that its software increases the image capturing efficiency by improving the quality of low dose imaging and is compatible with all scanner models, brands and field strengths.
30 November | Diagnostics
UCF RESEARCHERS DEVELOP NEW RAPID TEST TO DETECT VIRUSES LIKE COVID-19
Researchers at the University of Central Florida (UCF) in the US have developed a device to identify viruses, such as Covid-19, in the human body as quickly as rapid detection tests.
The new device has a 95% accuracy rate for determining if a person carries a virus, a claim that matches the accuracy of the gold-standard polymerase chain reaction (PCR)-based tests. However, unlike some tests, the device offers nearly instantaneous results.
The device uses nano-scale patterns of gold that reflect the virus signature in a blood sample. The optical sensor in the device uses nanotechnology to identify viruses present in the sample in seconds.
According to UCF, the new device can directly detect viruses without needing preparation or purification of blood samples, which further accelerates the test results.
30 November | Approvals
FDA APPROVES QIAGEN TB ASSAY FOR USE ON LIAISON XS PLATFORM
The US Food and Drug Administration (FDA) has approved the Qiagen Liaison QuantiFeron-TB Gold Plus assay for use on DiaSorin’s Liaison XS platform.
The decision comes approximately two years after the FDA approved the commercial launch of the product. The assay has been available on Liaison XL analyser platforms in the US since 2019.
An interferon-gamma release assay Liaison QuantiFERON-TB Gold Plus was developed by Qiagen and DiaSorin to streamline laboratory automation for latent tuberculosis (TB) screening. It looks for interferon-gamma from T-cells that have come across TB bacteria.
The latest regulatory approval from the FDA increases the accessibility of automation solutions for processing the Qiagen blood-based assay for latent TB detection in the US.
26 November | Approvals
MDOLORIS’ HFVI MOC-9 TECHNOLOGY RECEIVES MARKETING APPROVAL IN JAPAN
MDoloris Medical Systems has received regulatory clearance and marketing approval of its high frequency variability index monitor, HFVI MOC-9, in Japan.
The technology is claimed to be the first monitoring device developed for patients undergoing anaesthesia and analgosedation in the country.
MDoloris developed the solution for integrating into Masimo’s Root patient monitoring and connectivity hub to develop it into a full brain monitoring system. The hub integrates an array of technologies to offer multimodal monitoring and connectivity.
Derived from the heart rate variability, HFVI is a parameter similar to the Analgesia Nociception Index (ANI) in Europe. ANI allows healthcare providers to evaluate patients’ parasympathetic activity when undergoing surgical procedure.
1 December | Approvals
FDA CLEARS IMMUNEXPRESS’ SEPTICYTE RAPID TEST
The US FDA has granted 510(k) clearance for the fully automated SeptiCyte RAPID test from Immunexpress.
Developed in collaboration with Biocartis Group, the test distinguishes sepsis from non-infectious systemic inflammation in patients who are suspected of having sepsis.
The test is performed on Biocartis’ PCR-based molecular testing system, the Idylla platform. It comprises all the reagents which are required to quantify gene expression with the help of a reverse transcription PCR to determine the host response genes’ relative expression levels from whole blood.
1 December | Deal
HOLOGIC BOLSTERS LAPAROSCOPIC PORTFOLIO WITH BOLDER SURGICAL ACQUISITION
Hologic has closed its previously announced acquisition of surgical instrument manufacturer Bolder Surgical.
The acquisition adds Bolder Surgical’s advanced vessel sealing, dividing and dissection tools for laparoscopic procedures to Hologic’s surgical portfolio. It will also enable Hologic to offer Bolder’s devices to obstetrician-gynaecologist specialists.
Bolder Surgical offered its products in the US and on the international market. As part of the agreement, all Bolder devices will be moved to the Hologic Surgical portfolio immediately.
In brief
REVIVAL PARTNERS WITH QUANTA COMPUTER TO SCALE UP PRODUCTION OF COVID-19 TESTS
Revival Health has entered into a strategic partnership with Quanta Computer to scale up manufacturing capabilities of Covid-19 and blood biomarker tests, seeking to achieve a domestic capacity of 15 to 20 million rapid test units a month in the US. Revival will leverage Quanta’s manufacturing and robotics operational expertise for its rapid testing platform, LumiNow, and healthcare ecosystem, Move 78.
NOVACYT’S COVID-19 PCR TEST RECEIVES APPROVAL IN UK
The UK Health Security Agency has approved Novacyt’s genesig Covid-19 real-time PCR test under its Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021. The genesig Covid-19 assay is designed to target the ORF1ab gene and has the potential to detect all known Covid-19 variants and mutations.
SEEGENE SAYS ITS PCR-BASED TEST CAN DETECT OMICRON VARIANT
South Korean molecular diagnostics company Seegene has confirmed that its Allplex SARS-CoV-2 Master Assay can detect the new Covid-19 variant, Omicron. The PCR test identifies four wild-type SARS-CoV-2 genes (E gene, RdRP gene, N gene and S gene) and five notable S-gene mutations.
QIAGEN CONFIRMS PCR TESTS CAN DETECT NEW COVID-19 VARIANT
Qiagen has confirmed its SARS-CoV-2 PCR tests are effective in detecting the new Covid-19 variant, Omnicron. The company made the claim after assessing PCR tests against the genetic mutations of the new variant using data available in the GenBank and GISAID public databases.
