CerTest Biotec and BD announced a collaboration to develop a molecular diagnostic test for the monkeypox virus. The two companies will develop an assay that will leverage the BD Max open system reagent suite to validate the CerTest Viasure Monkeypox CE/IVD molecular test on the BD Max system.

The BD MAX system is fully integrated and automated, performing nucleic acid extraction and providing real-time PCR results for up to 24 samples across multiple syndromes in less than 3 hours. The system already includes assays for respiratory infections, sexually transmitted diseases, and gastrointestinal infections.

Like other CerTest tests, the Monkeypox PCR Detection kit will be offered in a lyophilized format. The test will also come in a tube that snaps into the test-specific position on the BD MX ExK TNA extraction strip.

“Through our collaboration with CerTest and their ability to rapidly transfer assays
on the BD MAX system, we will enable BD MAX system users around the world to access a test for the confirmation of monkeypox,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD.

DNAnexus and Twist Collaborate on Data Analysis Software for NGS

DNAnexus and Twist Bioscience have teamed to accelerate research and reduce time to design, validate, and commercialize new, high-quality next-generation sequencing (NGS)-based diagnostic tests. With this collaboration, Twist customers may use the integrated DNAnexus platform with Twist’s NGS Methylation Detection system and Unique Molecular Identifier (UMI) Adapter system to simplify data analysis after sequencing.

Analyzing unique methylation patterns within samples can help identify rare diseases, cancer, and other disorders. Highly sensitive hybridization capture-based technology is integrated into the tests to identify these patterns.

Twist’s UMI Adapter system also detects low-frequency variants in low-input sample sources to enable cancer research, the companies said. This collaboration lets users gain better access to a single, scalable, cloud-based environment to analyze these complex datasets.

“Our customers can now access industry-leading computational infrastructure platforms to support their bioinformatics needs and reduce their data analysis timeline after performing a sequencing run with our NGS Methylation Detection and UMI Adapter systems,” said Emily M. Leproust, CEO and co-founder of Twist Bioscience.

SD Biosensor and SJL Partners Acquire Meridian Bioscience

Meridian Bioscience, SD Biosensor, and SJL Partners have entered a definitive merger agreement under the terms of which the latter two companies will acquire Meridian in an approximately $1.53 billion all-cash transaction.

With this agreement, SD Biosensor aims to expand its network to the U.S. IVD market through Meridian and obtain strong management expertise from SJL Partners. In addition, Meridian representatives hope that the acquisition will allow the three companies to develop new products for the diagnostics market.

"The combination of Meridian's product commercialization team with deep expertise in the regulated U.S. market, SDB's broad product portfolio and scale manufacturing expertise, and SJL's execution experience and partnership model will further position the company for long-term success,” said Steve Sukjung Lim, chairperson and managing partner of SJL.

Shareholders of Meridian will receive $34 per share in cash, which represents a premium of approximately 32% over Meridian’s closing stock price the day before the consortium’s first offer before the market opened on March 18 of this year.

Grail, AstraZeneca Develop Companion Diagnostic Tests for Early-Stage Cancer

Grail has joined forces with AstraZeneca to develop and commercialize companion early-stage cancer diagnostic assays for use with AstraZeneca’s therapies. The collaboration between the two companies will start by developing companion diagnostic tests to identify patients with high-risk, early-stage cancer. Both Grail and AstraZeneca plan to use Grail’s technology to recruit patients with early-stage cancer for AstraZeneca’s analysis. Grail will use its methylation platform to perform tests on patients enrolled in AstraZeneca’s clinical trials.

“Grail has developed a novel approach to detect cancer signals in blood, regardless of whether or not the patient has clinical symptoms,” said Sir Harpal Kumar, president of Biopharma Business and Europe at Grail.

Grail already is known for its technology to optimize circulating tumor cell-free DNA testing for detection of early-stage disease and minimal residual disease.