Qiagen and OncXerna have entered into an agreement to advance development of the Xerna TME panel as a potential next-generation sequencing (NGS) companion diagnostic for OncXerna’s experimental drug navicixizumab. OncXerna is developing navicixizumab as a treatment for patients with ovarian cancer. Clinicians can order the test to determine if ovarian cancer patients whose dominant tumor type is driven by angiogenesis are more likely to benefit from treatment with the drug.
The Xerna TME panel uses proprietary RNA-based gene expression data and a machine learning-based algorithm to classify patients—based on the dominant biology of their cancer—so that they can be matched with therapies. Under a nonexclusive license, which is for research use only and clinical development programs, OncXerna has granted Qiagen the rights to integrate the Xerna TME panel into their NGS workflow solution.
The companies say the deal will advance the Xerna TME panel toward regulatory approval as an NGS companion diagnostic and adoption into medical practice.
BIOREFERENCE LABS ACQUIRES ARIOSA LAB PRENATAL BUSINESS FROM ROCHE
BioReference Laboratories announced that it has acquired the U.S. Ariosa centralized laboratory prenatal testing business from
Roche. Ariosa’s noninvasive prenatal screening (NIPS) test, the Harmony Prenatal Test, is one of the most widely studied tests used in prenatal screening and has been performed in over 1.5 million patients, the company said. GenPath, BioReference’s specialty health division, currently offers ClariTest Core, a NIPS test that uses the same core technology as the Harmony Prenatal Test. The acquisition of Ariosa will complement this current NIPS offering, according to BioReference Labs.
The company added that in 2020, there were about 6 million pregnancies in the U.S., and prenatal screening for Down syndrome had become common practice. Acquiring Ariosa allows BioReference Labs to expand its NIPS offerings and further underscores the company’s commitment to prenatal screening, it said.
PROMEGA AND HENLIUS DEVELOPING MICROSATELLITE INSTABILITY COMPANION DIAGNOSTIC
Promega and Henlius Biotech announced they will develop and commercialize a microsatellite instability (MSI) in vitro diagnostic kit to identify cancer patients likely to benefit from serplulimab, a novel anti-PD-1 monoclonal antibody (mAb).
MSI is a form of genomic instability caused by the insertion or deletion of repeating bases called microsatellites during DNA replication and the failure of the mismatch repair system (MMR) to correct these errors. MSI status is a measure of MMR deficiency commonly found in solid tumors. Tumors with MSI-high (MSI-H) status have shown higher response rates for immune checkpoint inhibitor therapies such as anti-PD-1 mAb drugs. Serplulimab was developed by Henlius for the potential treatment of MSI-H solid tumors.
For now, the kit will be available to doctors in China for MSI screening and immunotherapy options. China’s National Medical Products Administration recently granted priority review to a new drug application for serplulimab. The companion diagnostic method now being developed by the two companies is a multiplex polymerase chain reaction by capillary electrophoresis.
ILLUMINA ACQUIRES GRAIL TO SPEED ACCESS TO MULTICANCER EARLY-DETECTION TEST
Illumina announced acquisition of Grail, a healthcare company focused on early detection of multiple cancers. Illumina will hold Grail as a separate company during the European Commission's ongoing regulatory review of the Galleri blood test, which detects many different cancers before they are symptomatic, according to Illumina.
The review was prompted by concerns that Illumina’s vertical takeover of its former spinout could harm research and development efforts at competing diagnostic companies, according to Fierce Biotech. In August, the U.S. Federal Trade Commission said it seeks to undo Illumina’s $7.1 billion acquisition of Grail, alleging it would harm innovation and boost prices, Reuters reported.
Illumina officials say that the decision to make the acquisition and hold the companies separate permits the regulatory processes to proceed while safeguarding the deal without it expiring. The company says the deal will also accelerate the global adoption of next-generation sequencing-based multicancer early detection tests, increase accessibility, and improve patient outcomes. Information from the company says that 71% of all deadly cancers do not currently have a screening test. Grail’s Galleri test can detect more than 50 cancers across all stages. In 89% of the positive results, the test correctly identified the tissue of origin, with a specificity of 99.5%.