Quidel Corporation has acquired Ortho Clinical Diagnostics, one of the world’s largest in vitro diagnostics companies. The transaction is expected to close during the first half of fiscal year 2022.

The combined organization will unite the companies’ technologies and platforms to benefit customers with expanded access to clinical chemistry, immunoassay, molecular diagnostics, immunohematology, donor screening, and point-of-care diagnostics offerings, Quidel said. They added that the combined company will be poised to meet patient testing needs at all points of the care continuum, including reference labs, hospitals, physicians’ offices, urgent care centers, retail locations, and homes.

The deal will include access to Ortho’s broad global reach across 130-plus countries, accelerating growth for Quidel’s existing product portfolio and providing exposure to new, emerging markets.

Additionally, the deal will deepen Quidel’s innovation pipeline, diversify its product portfolio, and accelerate its product growth, the company said.

Mainz Biomed Acquires Exclusive Rights to Novel mRNA Biomarkers

Mainz Biomed recently announced an agreement to access Socpra Sciences Santé Et Humaines’ portfolio of novel mRNA biomarkers for potential future integration into ColoAlert, Mainz’s test for colorectal cancer (CRC).

Under the deal, Mainz has exclusive global rights to five gene expression biomarkers demonstrated to effectively detect CRC lesions, including advanced adenoma (AA), a pre-cancerous polyp often attributed to this deadly disease. The company cites peer-reviewed research that shows the biomarkers have overall sensitivities of 75% for AA and 95% for CRC, respectively.

If these statistical results are duplicated when the biomarkers are integrated into ColoAlert, company officials hope their test will be among the most robust and accurate at-home commercial diagnostic screening tests. The company plans a clinical study in Europe to evaluate whether the biomarkers improve ColoAlert’s utility for identifying AA while increasing rates of diagnostic sensitivity and specificity.

Mainz is currently marketing ColoAlert in Europe through partnerships with third-party laboratories for test kit processing. The company is preparing to submit ColoAlert for Food and Drug Administration approval.

Gestalt Diagnostics and MindPeak Provide Artificial Intelligence-Based Diagnostics

BioReference Laboratories will use new artificial intelligence (AI)-based diagnostic tools developed by MindPeak and Gestalt Diagnostics for aspects of routine clinical pathology. Specifically, BioReference Laboratories will use Gestalt Diagnostics’ digital pathology solution with MindPeak’s AI-based cancer diagnostics BreastIHC algorithm.

BioReference will use the BreastIHC algorithm to quantify breast cancer cells via AI software integrated in Gestalt Diagnostics’ PathFlow platform for streamlined access and workflow, making BreastIHC the first AI-based pathology product used in routine clinical practice in the U.S., according to MindPeak and Gestalt.

BreastIHC enables labs to instantly detect, classify, and quantify breast cancer cells stained via immunohistochemistry. The algorithm classifies the cells into positively stained tumor and unstained tumor cells. By differentiating tumorous and nontumorous structures, BreastIHC can improve scoring in the tumor microenvironment, MindPeak officials said. They added that BreastIHC can increase throughput and reporting speed.

Gestalt Diagnostic officials said their platform enables quick, efficient, and fully automatic interpretation and diagnosis.

BD Acquires Scanwell Health to Expand and Scale Digital At-Home Testing

Becton, Dickinson and Company (BD) announced it has acquired Scanwell Health, which markets smartphone-enabled at-home medical tests.

BD collaborated with Scanwell to develop the application used with the recently launched BD Veritor At-Home COVID-19 test. It is the first SARS-CoV-2 test to use a smartphone camera and app to capture and interpret results. According to BD, the test, smartphone camera, and application eliminate the human subjectivity involved in other visually read at-home antigen tests.

While other SARS-CoV-2 home tests use smartphones as part of their process, the BD Veritor test uses the smartphone as the analyzer to digitally interpret the test results and provide a definitive positive or negative digital display of testing results. The application also can securely store and report test results to businesses, public health authorities, and schools. The application stores test results, which can be referenced and displayed at any time by logging in.

Scanwell will become the digital platform upon which BD plans to develop at-home diagnostic tests for a range of infectious diseases including COVID-19, influenza A and B, and group A strep.

Illumina and Syapse Partner on Study of Comprehensive Genomic Profiling in Advanced Cancer

A new partnership between Syapse and Illumina focuses on research to evaluate large panel biomarker testing patterns across U.S. community oncology practices.

An announcement by the companies said the collaboration will explore the uptake and actionability of comprehensive genomic profiling among practices whose clinicians treat patients with advanced cancers. The collaboration seeks to understand biomarker testing patterns and actionability of test results as a first step toward facilitating improved clinical decision-making at both the provider and health system level.

Syapse officials said that a key goal is identifying a biomarker that qualifies patients for targeted therapy early enough to be effective and to spare them from potentially less effective and more difficult treatments. Illumina officials also added that the collaboration is intended to advance personalized care.