Latest News

New Frontiers in COVID Testing, Cancer Screening, Single-Cell Spatial Genomics, More

February 2, 2022 | Skin health, single-cell spatial genomics, diabetic kidney disease, MS biomarkers, lung and colorectal cancer screening. Plus: home testing of peripheral neuropathies, new COVID tests, and more.


BioIVT announced the launch of its Good Manufacturing Practice (GMP) grade human AB serum, a cell culture supplement to enhance the development and manufacturing of cell and gene therapies. Human AB serum supports in vitro cell expansion by providing many of the growth factors, vitamins, nutrients, trace elements, and transport factors found in an in vivo environment. By helping to produce biologically relevant conditions, it allows many primary human cells to grow at a faster rate. This is particularly important for autologous therapies that require using a person’s own cells or tissues, which may divide at a slower rate due to chemotherapy. BioIVT’s GMP-grade human AB serum is produced using the same optimized protocols and enhanced regulatory oversight of source material collection, production, and processing as their research-use only material. All donor units are tested at the collection facility for viral markers in accordance with current US Food and Drug Administration regulations to ensure they are non-reactive prior to use. Additional testing is available according to customers’ needs. Press release

Medix Biochemica, a global leader in critical in vitro diagnostics (IVD) raw materials, has announced a 100% share acquisition of myPOLS Biotec GmbH (“myPOLS Biotec”), a German manufacturer of innovative and high-quality raw materials for molecular diagnostics. All founders of myPOLS Biotec will remain involved in the business following the acquisition. This announcement will broaden Medix Biochemica's portfolio of molecular diagnostic raw materials for the IVD industry, complement its scientific expertise and strengthen its local presence in Western Europe. With myPOLS technology, Medix Biochemica will enable customers to shorten their assay development time and complexity, and perform molecular testing directly from crude samples. Press release.

Seegene Inc. of South Korea announced that it received approval for its Allplex SARS CoV-2 FluA/FluB/RSV Assay under Health Canada's Interim Order on January 11. Seegene's Allplex SARS CoV-2 FluA/FluB/RSV Assay is a multiplex real-time PCR assay that enables simultaneous amplification and differentiation of respiratory symptoms. In a single test, it can distinguish among Influenza A or B, RSV, and COVID-19. To support Canada’s surging demand for COVID-19 tests, Seegene delivered 340,000 COVID-19 tests by a charter flight on January 13. Press release.

L'Oréal and Verily, an Alphabet precision health company, announced a strategic partnership to advance skin health. The first-of-its-kind partnership in the beauty industry is expected to entail two programs aimed to better understand and characterize skin and hair aging mechanisms and to inform L'Oréal's precision beauty tech strategy and product development. The first is a strategic research collaboration to establish a longitudinal biological, clinical, environmental view of skin health. It combines L'Oréal's deep scientific knowledge of skin and Verily's comprehensive clinical science capabilities to decode and discover the links between exposome, skin aging, and deep biology of the skin. The second is a partnership between Verily's R&D Team and L'Oréal's Active Cosmetics Division to explore the development of new technologies and tele-diagnosis solutions such as sensors and AI algorithms for dermatology and skincare. Press release.

Ginkgo Bioworks announced the acquisition of Project Beacon COVID-19, a Boston-based social benefit organization focused on helping to increase the capacity, availability, accessibility, and affordability of COVID-19 testing. Under the terms of the deal, Ginkgo acquired Project Beacon’s assets and will assume responsibility for Project Beacon’s ongoing operations, providing COVID-19 monitoring tools to communities in Massachusetts and other areas. Throughout the pandemic, Ginkgo has supported widespread COVID-19 monitoring through its biosecurity and public health initiative, Concentric by Ginkgo. Today, Concentric provides COVID-19 monitoring services for over 280,000 individuals per week through its programs in K-12 schools, correctional facilities, airports, and other community settings. Concentric conducted over 3 million tests in the second half of 2021. With this acquisition, Concentric will integrate Project Beacon’s partner and customer relationships, digital platform, and several key personnel into its broader efforts. Press release.

PINC AI, the technology and services platform of Premier, Inc., announced the launch of INsights, an enhanced self-service healthcare solution for the creation of customized, on-demand analytics. INsights is a vendor-agnostic analytics platform that accesses PINC AI’s cleansed, standardized, and risk-adjusted healthcare data, covering more than 45 percent of all U.S. hospital inpatient discharges. INsights users can leverage pre-developed analytics developed by PINC AI and conduct customized data queries and visualizations using PINC AI or their own data sources. The platform will also serve as a development community, where users can crowdsource and share information, measures, queries, and more with others. INsights will be hosted on Microsoft Azure Synapse Analytics. Press release.

Vizgen, a life science company dedicated to improving human health by visualizing single-cell spatial genomics information, has announced that their MERSCOPE Platform is now broadly available across the United States. Additionally, Vizgen has released its second, open-access data set—the MERFISH Mouse Liver Map, along with an interactive web-based data visualization platform. MERSCOPE is a one-of-a-kind single-cell spatial genomics platform technology that streamlines and automates MERFISH experiments, making them more accessible to a wider variety of labs, such as those led by researchers in academia, core labs, and pharmaceutical companies. The MERSCOPE Platform offers a user-friendly, full solution workflow facilitating each step of a MERFISH experiment, making it an attractive option for labs seeking to quickly and efficiently incorporate single-cell, spatial transcriptomics into their research. The instrument is accompanied by a custom gene panel design portal, reagents and consumables, an analytical computer for integrated image processing, and interactive data visualization software. The MERSCOPE Platform is also flexible and amenable to a large variety of sample or tissue types. Together these features enable the spatial profiling of hundreds of millions of individual transcripts from hundreds of genes across hundreds of thousands of cells in a single instrument run. Press release.

Achiko AG reported that new optimizations of its affordable, saliva-based, rapid AptameXCovid-19 test correctly differentiated 100% of test samples using an RT-PCR cycle threshold of 33, indicating the system’s ability to deliver a > 97% sensitive and > 97% specific rapid test at a wider range of viral loads than most other rapid tests. After the recent improvements, AptameX achieved 100% sensitivity and specificity in a controlled experiment conducted in Indonesia using 58 human Covid-19 samples. Press release.

MIP Diagnostics has announced that its synthetic SARS-CoV-2 antibody (COVID-19 nanoMIP) can detect the Omicron variant as well as previously proven Alpha, Beta, Delta, and Gamma variants of the COVID-19 virus. Detection of Omicron was confirmed by laboratory testing in buffer using surface plasmon resonance (SPR), with a magnitude of specific response comparable to other variants of the virus previously tested. Originally developed in under 8 weeks, the MIP Diagnostics COVID-19 nanoMIPTM offers IVD manufacturers a host of benefits including high selectivity and sensitivity demonstrated to the picogram level in a number of COVID-19 sensor devices. MIPs will also provide the superior shelf life and storage properties required by the IVD market as self-testing becomes more prevalent across multiple disease states following the COVID-19 pandemic. Press release.

DiaSorin Molecular announced an updated version of the Simplexa SARS-CoV-2 Variants Direct assay (RUO) to enable the detection of mutations associated with the Omicron variant (B.1.1.529). The assay helps to streamline and expedite the pre-selection process of positive samples that would benefit from further sequencing, which maximizes the effectiveness of monitoring programs for the spread of concerning variants. The Simplexa SARS-CoV-2 Variants Direct is a Research Use Only (RUO) assay and is not for use in diagnostics procedures. The assay works directly on nasopharyngeal and nasal swab specimens that were identified as positive for SARS-CoV-2 and allows for the in vitro qualitative detection of mutations present in potential variants of clinical interest including Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Epsilon (B.1.427/B.1.429), Zeta (P.2), Eta (B.1.525), Iota (B.1.526/B.1.526.1), Kappa (B.1.617.1/ B.1.617.3), Mu (B.1.621), and Omicron (B1.1.529). The kit format consists of pre-aliquoted reagents that are ready for use while leveraging Direct Amplification Disc technology and the melting curve analysis capabilities of the LIAISON MDX instrument. Press release.

Renalytix announced the publication of positive study results for KidneyIntelX as a risk monitoring tool to assess impact and response to novel treatments for patients with diabetes and chronic kidney disease (CKD) at increased risk for cardiovascular events. KidneyIntelX combines three proprietary biomarkers (sTNFR1, sTNFR2, and KIM-1) and seven clinical variables from a patient’s electronic health record with machine learning to generate a patient-specific risk score. Study data support the value of KidneyIntelX to risk-stratify disease, monitor treatment response, and assess changes in risk over time, showing clinical utility not only as a bioprognostic™ risk assessment tool but also as a longitudinal monitoring tool. The study identified samples from patients with baseline diabetic kidney disease (DKD) to assess the association of baseline and changes in KidneyIntelX with subsequent DKD progression using the CANVAS (CANagliflozin cardioVascular Assessment Study) multinational clinical trial design as framework. Risk and response to the novel therapeutic were assessed in 1,325 participants from the trial with concurrent DKD and available baseline plasma samples, and KidneyIntelX accurately risk-stratified this large multinational cohort for progression of DKD. Press release.

New Zealand diagnostic biotech company Pictor’s COVID-19 antibody testing regime has completed validation trials at two separate sites in the United States. The Pictor test simultaneously detects the presence of both anti-Spike Antigen (SP) antibody and anti-Nucleocapsid antigen (NP) antibody in a single test. Pictor now aims to fast-track adoption of its low-cost, high-performance, high-throughput tests by obtaining FDA Emergency Use Authorization. Clinical trials conducted by Florida-based Boca Biolistics showed 99.1%. sensitivity for SP and 97.3% for NP. Corresponding specificities were 95.2% for SP and 98.6% for NP. Pictor’s PictArray SARS-CoV2 assay is unique in its ability to detect both SP and NP antibodies in one test, differentiating people with antibodies associated with previous infection (SP and NP antibodies) from those who have been vaccinated (SP antibodies only). Primex Laboratories of Van Nuys, California has also conducted clinical testing to evaluate Pictor’s serology test, and those results are currently being analyzed. Pictor has launched an equity fundraising round to enable it to continue to expand its manufacturing capability in New Zealand and in market resources in key international markets including the US, India and Europe. Press release.

Imeka, a neuroimaging company combining diffusion imaging and AI to map white matter integrity, announced a collaboration with Atara Biotherapeutics, Inc. to utilize Imeka's novel biomarker technology in a Phase 2 clinical study of patients with progressive forms of multiple sclerosis (MS). Imeka's non-invasive Advanced Neuro Imaging Endpoints (ANIE) biomarker platform will measure the potential effect of Atara's investigational treatment, ATA188, on neuroinflammation and remyelination in the brain and spinal cord in patients with primary progressive MS and secondary progressive MS. Atara is currently evaluating ATA188 in the Phase 2 EMBOLD clinical study in the U.S. and Australia. Press release.

Withings has announced the acquisition of Impeto Medical, a specialist in R&D, manufacturing, and distribution of innovative medical devices for physicians. This announcement incorporates the ownership of Impeto’s SUDOSCAN technology for detecting and tracking peripheral neuropathies by measuring the ability of sweat glands to release chloride ions in response to an electrical stimulus on the palms of the hands and soles of the feet. The degeneration of small nerve fibers reduces sweat gland innervation and impairs sudomotor function. The procurement will strengthen the research and development of new technologies for future Withings health products and services. The first Withings product to incorporate SUDOSCAN technology will be Withings Body Scan. As part of the deal, Withings has acquired all Impeto technology IP and patents, and Impeto Medical staff has become a full part of Withings. Press release.

Caris Life Sciences and HotSpot Therapeutics, Inc., which specializes in allosteric therapeutics, announced a partnership to advance precision medicine approaches for HotSpot’s emerging product portfolio. The partnership will focus initially on two therapeutic programs, the first of which is HotSpot’s novel allosteric inhibitor of the E3 ubiquitin ligase CBL-B, an important target in cancer immunotherapy, spanning from pre-first-in-human trials through potential companion diagnostics and launch. Caris has amassed molecular data on more than 356,000 patients and clinical outcomes on more than 275,000 patients. Insights gained from Caris’ best-in-class real-world clinico-molecular matched database will be leveraged to optimize HotSpot’s development programs, including cohort design, biomarker strategy, and future CDx needs and strategies. Under the terms of the agreement, patients enrolled in HotSpot’s Phase 1 through Phase 3 trials will undergo longitudinal testing with Caris’ comprehensive tissue and liquid molecular profiling analysis. In addition to the commitment to profiling and real-world data insights, Caris is granted negotiation rights for CDx programs of partnership therapeutic programs. While detailed partnership financial terms have not been disclosed, the financial commitment is based on program specifics and has the potential to exceed $40 million if programs progress through regulatory approval and additional milestones are met. Press release.

Sosei Heptares and Verily, an Alphabet precision health company, announced that they have entered into a strategic research collaboration. The research agreement brings together the complementary capabilities of Verily’s immune profiling and Sosei Heptares’ G-protein-coupled receptor (GPCR) structure-based drug design. The companies will collaborate to prioritize the GPCR targets using Sosei Heptares' StaR (stabilized receptor) platform and structure-based drug design expertise, with the goal of generating lead molecules for further development or out-licensing. Press release.

Mainz Biomed N.V., a molecular genetics diagnostic company specializing in the early detection of cancer, announced it has entered into a Technology Rights Agreement with Socpra Sciences Santé Et Humaines S.E.C. to access a portfolio of novel mRNA biomarkers for potential future integration into ColoAlert, the company’s easy-to-use detection test for colorectal cancer. Mainz is currently marketing ColoAlert in Europe through its unique business model of partnering with third-party laboratories for test kit processing versus the traditional methodology of operating a single facility. Mainz is also preparing to initiate ColoAlert’s regulatory pathway for approval in the United States. Press release.

Median Technologies announced outstanding performance for its iBiopsy Lung Cancer Screening (LCS) CADe algorithm in detecting potentially cancerous lung nodules. iBiopsy LCS offers an integrated detection/diagnosis approach (CADe/CADx) for reviewing radiographic images. Median Technologies announced results specifically focused on the lung nodule detection function, which applies Median’s proprietary deep learning algorithms to low-dose computed tomography (LDCT). The results are based on a cohort of 888 patients from the LIDC/IDRI public database. The 10-fold cross-validation method was used for training (800 train/88 test patients). The overall result, obtained by aggregating the ten test fold results, showed a sensitivity of 94.9% for a false positive rate of 1 per CT scan. Press release.

Roche announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The tests, available already in January, use a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older or by an adult for children aged 2-13 years. The test is able to produce accurate, reliable, and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron. Press release.