UC BERKELEY AND GLADSTONE SCIENTISTS DEVELOP NEW COVID-19 TEST

07 December | Device development

Researchers from UC Berkeley and Gladstone Institutes have developed a new Covid-19 diagnostic test that can provide results in 15 to 30 minutes using a smartphone camera.


The new clustered regularly interspaced short palindromic repeats (CRISPR)-based test can also provide an estimate of viral load or the number of virus particles in a sample. This will aid doctors in monitoring disease progression and analysing how contagious a patient might be.


The technique has been designed in partnership with Gladstone Institute of Virology director Dr Melanie Ott, along with Berkeley professor and Gladstone senior investigator Jennifer Doudna. Doudna won the 2020 Nobel Prize in Chemistry for co-discovering CRISPR-Cas genome editing. This technology is the basis of the test.


Doudna said: “One reason we’re excited about CRISPR-based diagnostics is the potential for quick, accurate results at the point of need.


“This is especially helpful in places with limited access to testing or when frequent, rapid testing is needed. It could eliminate a lot of the bottlenecks we’ve seen with Covid-19.”


A lot of Covid-19 diagnostic tests work on the polymerase chain reaction, which searches for pieces of the SARS-CoV-2 viral RNA in a sample.


It works by isolating the viral RNA, then converting the RNA into DNA and amplifying the DNA segments, making many identical copies, for easy detection of the segments. The new test uses the CRISPR Cas13 protein, which directly attaches and cleaves RNA segments.


Without the DNA conversion and amplification steps, the test cuts down the time required to complete the analysis. In the diagnostic test, CRISPR Cas13 proteins are programmed to identify segments of SARS-CoV-2 viral RNA and then combined with a probe that turns fluorescent when cleaved.

07 december | deals

SHERLOCK BIOSCIENCES AND TOLO BIOTECH SIGN DIAGNOSTIC TECHNOLOGIES DEALS


Engineering biology firm Sherlock Biosciences and China-based Tolo Biotech have signed exclusive license agreements for their diagnostic technologies.


Under the deal, Sherlock gained exclusive rights in the US to Tolo’s CRISPR-Cas12 diagnostic technology, which includes Cas12a and Cas12b.


The company granted Tolo the exclusive rights to the CRISPR-Cas13 SHERLOCK diagnostic platform in Greater China.


Sherlock Biosciences co-founder, president and CEO Rahul Dhanda said: “We are very pleased to enter this agreement with Tolo, which complements Sherlock’s diagnostic rights to the Cas12 and Cas13 proteins licensed from the Broad Institute.


“With the addition of these exclusive Cas12 rights to Sherlock’s IP portfolio, as well as partnering with Tolo as our exclusive partner in China, we have secured our position as the global leader in CRISPR diagnostics.”

04 december | Covid-19

DRAWBRIDGE AND CAMBRIDGE UNIVERSITY TO USE ONEDRAW DEVICE IN COVID STUDIES


Drawbridge Health has partnered with the UK’s University of Cambridge Medical Research Council Epidemiology unit to use the OneDraw Blood Collection Device in a Covid-19 study.


The Fenland Covid-19 Study is being carried out to analyse the prevalence of prior infections with the disease.


Launched in July, the study has enrolled 4,000 participants and is led by MRC Epidemiology unit director professor Nick Wareham.


The proportion of people who have been previously infected with Covid-19 in the Fenland cohort is the study’s primary aim. The device is being used in the study to collect remote blood samples from participants for repeated Covid-19 serological testing over nine to 12 months.


With the OneDraw device, participants can collect blood samples at home and send them to the laboratory for analysis.

04 december | device development

OMRON LAUNCHES WHEEZE DETECTION DEVICE FOR PAEDIATRIC USE


OMRON Healthcare has launched WheezeScan, the world’s first clinically validated automatic device for home-use to detect wheezing in young children aged between four months and seven years.


With the device’s dependable accuracy, parents can check whether a child is wheezing and take steps in accordance with the child’s doctor prescribed treatment plan.


A common asthmatic symptom in children under five years, wheezing does not always sound the same. WheezeScan can give an objective assessment of the presence of wheezing with its intuitive design.


Parents can hold the device firmly below their child’s right collarbone for 30 seconds and wait for a Wheeze or No Wheeze identification.


WheezeScan’s sleek and ergonomic, light and portable design helps parents to carry it at all times and eradicate ambiguity during breathing distress.


With advanced listening technology, WheezeScan can detect sounds in a child’s wheezing that parents might not be able to hear.

03 december | regulation

FDA GRANTS EUA FOR ROCHE’S TEST TO MEASURE SARS-COV-2 ANTIBODY LEVELS


The US FDA has granted emergency use authorisation (EUA) to Roche’s immunoassay, Elecsys Anti-SARS-CoV-2 S antibody test, for the in vitro determination of antibodies to SARS-CoV-2.


Elecsys can measure the level of antibodies in people who are exposed to the SARS-CoV-2 with a blood sample.


The serology test targets antibodies that are directed against the spike protein, which helps the virus to attach to a host cell receptor. The binding enables the virus to enter the host cell.

03 December | approvals

HEALTH CANADA APPROVES ABBOTT’S SENSOR-BASED GLUCOSE MONITOR SYSTEM


Health Canada has approved Abbott’s sensor-based glucose monitoring technology, FreeStyle Libre 2, for adults and children aged four and above with diabetes.


The system continuously measures glucose levels every minute with customisable, optional real-time alarms to alert users of critical events like hypoglycemia (low glucose levels) and hyperglycemia (high glucose levels).


Eliminating the need for painful fingersticks, the wearable technology delivers accurate and actionable information to people with diabetes and enables better management of their condition.

In brief

NHS TO TRIAL BLOOD TEST THAT CAN DETECT OVER 50 CANCER TYPES

The UK National Health Service is set to initiate the trial of  the Galleri blood test, which can potentially detect over 50 types of cancers. Developed by GRAIL, the test is capable of detecting early-stage cancers through a simple blood test.

US FDA GRANTS APPROVAL FOR CERUS’ BLOOD SYSTEM

The US Food and Drug Administration (FDA) has granted approval for Cerus’ INTERCEPT Blood System for Cryoprecipitation. The system, which secured breakthrough device designation, can be used to produce Pathogen Reduced Cryoprecipitated Fibrinogen Complex for treating and controlling bleeding, including massive hemorrhage, linked to fibrinogen deficiency.

LIGHTHOUSE LAB IN UK BEGINS PROCESSING OF COVID-19 TESTS

The Lighthouse Lab in Charnwood, Loughborough, UK has initiated Covid-19 testing sample processing using PerkinElmer solutions as part of its partnership with the Department of Health and Social Care. It will support the UK Government’s NHS Test and Trace programme.

CANON MEDICAL TO EXPAND AI-BASED IMAGE RECONSTRUCTION TECHNOLOGY

Canon Medical is set to expand its Advanced intelligent Clear-IQ Engine Deep Learning Reconstruction (DLR) to additional modalities, clinical indications and systems by integrating accessible artificial intelligence (AI) for improved image quality to more patients. It will contribute to the broad availability of DLR imaging technology.

HBKU SCIENTISTS DEVELOP TOOL TO SCREEN PREDIABETES RISK SCORE

Scientists at Hamad Bin Khalifa University’s (HBKU) Qatar Biomedical Research Institute and Qatar Computing Research Institute have published the first risk tool to screen for prediabetes in the Middle East.

03 december | deals

EXACTECH ACQUIRES WEARABLE SOLUTIONS MAKER MUVR LABS


Exactech has acquired intelligent patient wearables and digital communication solutions maker Muvr Labs to expand its Active Intelligence Platform of Smart Technologies portfolio.


The Muvr platform has been designed to help surgeons to connect with their joint replacement patients throughout the journey of care.


It has patient wearables, mobile device applications and chatbot texting, which enables surgeons to remotely monitor patient recovery. In addition, the wearable device delivers real-time data to the healthcare team on each patient’s experience and recovery.

02 December | regulation

FDA GRANTS BREAKTHROUGH DESTINATION FOR HOLOGIC’S CANCER TECHNOLOGY


The US FDA has granted clearance to medical technology company Hologic’s new deep learning-based software, Genius AI Detection technology, for breast cancer.


The technology is designed to support radiologists in detecting subtle potential cancers in breast tomosynthesis images.


The company also announced that the Genius AI Detection is now commercially available.


According to studies, Genius AI Detection software, when used along with the Genius 3D Mammography exam, facilitates identification and early detection of breast cancer.


It works by highlighting areas with subtle potential cancers that can be difficult for the radiologist to detect for further examination.


In addition, it can provide higher sensitivity and lower false-positive rate compared to Hologic’s older generation CAD products.

In brief

Chumakov Center initiates Covid-19 vaccine candidate trials

Russia’s Chumakov Center has started clinical trials of its potential Covid-19 vaccine in St Petersburg. The 30 participants are healthy volunteers aged 18-45 years who tested negative for Covid-19 and with the absence of antibodies to the virus.

Edesa Biotech gets FDA approval to trial EB05 for Covid-19 treatment

Edesa Biotech has received FDA approval to initiate Phase II clinical trial of its investigational drug EB05 to treat hospitalised patients with Covid-19. EB05 treatment aims to suppress fluid accumulation, lung injury and inflammation.

Dr Reddy’s and RDIF receive DCGI approval for Sputnik V human trial

Dr Reddy’s Laboratories and Russian Direct Investment Fund (RDIF) have received approval from the Drug Control General of India (DCGI) to conduct a Phase II/III human trial of Sputnik V Covid-19 vaccine in India. 

Russia grants approval to second vaccine for Covid-19

Russian health authorities have approved the Covid-19 vaccine EpiVacCorona, developed by the Vector State Virology and Biotechnology Center in Siberia. Researchers tested the vaccine in Phase I and II trials prior to receiving provisional registration.

FDA approves ImmunityBio Phase I Covid-19 vaccine trial

ImmunityBio has received FDA clearance to initiate a Phase I trial of its novel Covid-19 vaccine candidate, hAd5-COVID-19, which is engineered to activate T-cells and antibodies against SARS-CoV-2.