Dear LabPulse.com reader:
A blood test newly approved by the U.S. Food and Drug Administration (FDA) can help doctors predict more accurately and sooner whether a woman will develop severe preeclampsia during pregnancy, according to its developers. The new prognostic test detects soluble fms-like tyrosine kinase 1 (sFlt1) and proangiogenic placental growth factor (PlGF), two biomarker proteins in the blood that more accurately predict poor preeclampsia outcomes. In May, the FDA granted a de novo request from Thermo Fisher Scientific, permitting it to market tests that use the biomarkers in the U.S. Plans are in place to offer it to patients at the University of Chicago Medicine.
Pathogenic variants in the CFTR gene cause cystic fibrosis (CF). Being a carrier of a variant has no impact on health but creates a risk that the person could have a child with CF. If both parents are carriers, there is a 25% chance that their child will have CF. Screening can identify people who carry the variants and enable them to make informed decisions about having children and prenatal testing. Now, the American College of Medical Genetics and Genomics (ACMG) has quadrupled the number of CFTR variants it recommends for cystic fibrosis carrier screening.
In IVD company news this week, Roche announced that its Cobas HPV test has been awarded World Health Organization (WHO) prequalification, expanding the screening tool's availability in countries that rely on the global organization’s list of prequalified suppliers in making purchasing and implementation decisions. The Cobas HPV test is used for routine cervical cancer screening, including HPV primary screening, co-testing with cytology, and for triage of women with abnormal cytology, to assess the risk for cervical precancer and cancer.
MGI Tech, a Shenzhen, China-based firm focused on the development and distribution of sequencing instruments and reagents, on Wednesday announced that it has signed a licensing agreement with Xpress Genomics. The agreement is aimed at developing scalable solutions that combine Xpress Genomics’ deep single-cell RNA sequencing expertise with MGI's automation and sequencing technologies.
Seegene said Wednesday that it is discussing the expansion of a partnership with Werfen for the Spanish and Portuguese marketplaces. The partnership, executed through Seegene's OneSystem initiative, would lead to the joint development of syndromic quantitative polymerase chain reaction (qPCR) assays suitable for the Spanish and Portuguese healthcare systems, including assays for sexually transmitted infections and drug resistance.
On Thursday, we saw that molecular diagnostics company Biocartis plans to lay off 140 people, approximately 25% of its workforce, in a reorganization aimed at reducing annual operating expenses.
Thanks for reading.
Leo O’Connor
Editor in Chief
