To improve at-home SARS-CoV-2 testing, Gauss, a healthcare computer applications company, and Cellex, a biotechnology company specializing in point-of-care testing, have teamed to develop the first-ever rapid, at-home and point-of-care SARS-CoV-2 antigen test. The test would be the first of its kind that allows users to perform the test themselves and receive results at home.

Cellex is currently in the midst of clinical trials for its rapid antigen test that detects the nucleocapsid protein found on the SARS-CoV-2 virus from nasal swab samples. Results from clinical trials show this test has nearly 90% sensitivity and 100% specificity. The partners plan to combine Cellex’s antigen test with Gauss’ new artificial intelligence mobile application to allow patients to scan and receive test results themselves by using their smartphones. Gauss’ mobile app provides users with video instructions on collecting the sample and performing the test to receive results in seconds. According to the companies, the app will also contain an automated feature for patients and healthcare professionals to share medical data. 

“The integration of Cellex’s accurate, at-home rapid antigen test with Gauss’s mobile app offers a scalable solution to significantly reduce transmission of COVID-19 and help society mitigate the impacts of the pandemic until a vaccine is widely available,” said Siddarth Satish, Gauss founder and CEO. “By embedding advanced computer vision algorithms within a thoughtfully designed user experience, we can enable consumers to perform a rapid test in their own homes simply by using their smartphone cameras.”

Currently, the partners are working to receive Food and Drug Administration emergency use authorization for the test.

Illumina, Grail Announce $8 Billion Deal for Early Cancer Detection

In an $8 billion deal, Illumina announced its planned acquisition of Grail, a healthcare company that specializes in early detection of cancer. Grail was founded by Illumina in 2016 and launched as its own company to further research on cancer detection, diagnosis, and monitoring.

As a stand-alone company, Grail has successfully enhanced its research and technology to develop Galleri, a multi-cancer screening test set to launch in 2021. According to Grail, Galleri detects early cancer signs through cell-free DNA analysis and has proven its success in detecting over 50 cancer types. Through the acquisition, the partners expect to improve blood-based screening of cancer, which can lead to better treatment options for patients at a lower cost.

Additionally, the deal will allow both companies to expand their platforms and commercialization opportunities. By acquiring Grail, Illumina will be able to enhance its portfolio to include cancer care. In return, Illumina will provide Grail with commercialization opportunities across the globe. The agreement also allows Illumina to advance its work in clinical genomics by not only providing its next-generation sequencing platform, but also positioning itself as the main distributor of clinical tests.

The deal is expected to close in 2021 and includes upfront cash and stock transactions.

NIH Grant Provides Funds for Scanwell At-home CKD Test

Scanwell Health, developer of at-home lab tests, announced that it received a $1.6 million National Institutes of Health Small Business Innovation Research (SBIR) grant to further production of its at-home test for chronic kidney disease (CKD).

The CKD test designed by Scanwell will allow patients to rapidly screen their own urine for excess protein, a potential symptom of the disease. Currently, researchers at healthcare centers across the country are performing studies using the test. Patients receive urine testing kits through the mail, and through the Scanwell mobile app, scan the urine sample to quickly view results. With the SBIR grant, Scanwell will be able to further studies before submitting the test for approval to the Food and Drug Administration.

Research shows that most Americans diagnosed with CKD are asymptomatic. Though there are no current cures for the disease, experts have found that the earlier CKD is diagnosed, the better chance there is of survival. Through the rapid at-home test, Scanwell hopes to drive more timely diagnoses of CKD, which could result in improved early treatment options for patients.

Siemens and Novartis Develop Assay for Multiple Sclerosis

Siemens Healthineers and Novartis Pharma, a pharmaceutical company that focuses on neuroscience, have entered into an agreement to develop a serum neurofilament light chain (NfL) immunoassay for patients with multiple sclerosis (MS) and other neurological diseases. Through the partnership, the companies plan to further develop diagnostic tests that support Novartis’ therapeutic infrastructure.

NfL, a biomarker for nerve cell injury, is measured through spinal fluid and blood. Research shows that blood NfL levels tend to vary with severity of neurological conditions. With the agreement, Novartis will benefit from Siemens’ specialization in clinical diagnostics and testing platforms, such as the Advia Centaur and Atellica. Serum NfL would expand Siemens’ Laboratory Diagnostics Neurology test menu.

“We are looking forward to our collaboration with Novartis as it promises to yield innovative diagnostic solutions to address critical unmet clinical needs,” said Deepak Nath, PhD, laboratory diagnostics president at Siemens. “Our initial focus on blood-based diagnostic solutions for MS patients is another example of Siemens Healthineers’ commitment to shape the future of precision medicine.”

Patient Data Provides Answers in New COVID-19 Question Portal

A new healthcare platform aims to provide patients and healthcare experts with new research on COVID-19 using patient record data from hospitals. The program, Reliable Response Data Discovery (R2D2), will allow individuals to submit COVID-19-related questions through an online portal,

According to R2D2, each submitted question will be translated into codes for participating hospitals to run on their own patient medical records, maintaining privacy for patient identity. The computer system will collect the most relevant information from patient data to then post a response back to the website. The program can obtain information from over 45 million patients and includes hospitals ranging from large metropolitan areas to smaller community health centers for diverse results.

“No single hospital alone has treated enough patients with COVID-19 to be able to see reliable patterns emerge and use that information to guide the direction of new studies. That’s why we formed the R2D2 Consortium,” said Lucila Ohno-Machado, MD, PhD, chair of the Department of Biomedical Informatics at University of California San Diego Health and head of R2D2.