FDA approves Roche and BD HPV self-collection
June 2024—The Food and Drug Administration in May approved the two HPV self-collection approaches from Roche and BD.
Roche’s self-collection solution is approved for use with its Cobas HPV test, which runs on the Cobas 4800 and the fully automated 5800/6800/8800 systems.
In announcing its news, BD said the approval allows women to self-collect vaginal specimens in a health care setting, which could include nontraditional locations such as retail pharmacies or mobile clinics.
Both companies are working with the National Cancer Institute in its Cervical Cancer Last Mile Initiative, which is focused on ways to reach underscreened and unscreened people. It’s a public-private partnership that brings together federal agencies, industry partners, and professional societies to contribute evidence about the accuracy and clinical effectiveness of self-collection-based HPV testing for cervical cancer screening. Roche said in its announcement that the public-private partnership facilitated in part the regulatory pathway toward approval of its self-collection solution.
The Self-Collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) trial is a nationwide, multicenter trial and associated studies, with independent evaluation of multiple self-collection devices and HPV assays for usability, accuracy, acceptability, and effectiveness. Participant enrollment begins this summer.
Quest to acquire select assets of PathAI Diagnostics
Quest Diagnostics will acquire select assets of PathAI Diagnostics, the business of PathAI that provides anatomic and digital pathology laboratory services, under the terms of a definitive agreement. At closing, PathAI Diagnostics’ digitized laboratory in Memphis will become Quest’s AI and digital R&D and solutions center, supporting Quest’s specialty pathology businesses, AmeriPath and Dermpath Diagnostics.
PathAI will continue to support its biopharmaceutical clients with clinical trial services at its biopharmaceutical laboratory, which is separate from the diagnostic laboratory business.
The transaction is expected to be completed in the second quarter of this year.
Under separate agreements, Quest will license PathAI’s AISight digital pathology image management system to support its pathology laboratories and customer sites in the United States. The two entities may also pursue opportunities for Quest to aid PathAI’s algorithm product development.
Qiagen partners with FBI to develop dPCR assay for use in forensics
Qiagen announced in May a cooperative research and development agreement with the U.S. Federal Bureau of Investigation to develop a novel test for its QIAcuity digital PCR devices that will strengthen forensics by improving the quantification of DNA in human samples.
The aim of the collaboration is a digital PCR assay that can simultaneously quantify in absolute terms nuclear and mitochondrial DNA concentrations and male DNA and include quality markers for degradation and inhibition.
Qiagen’s QIAcuity platform uses nanoplates to disperse a sample over thousands of tiny partitions and then read the reaction in each one simultaneously to quantify genetic traces. The company says the dPCR technology used in QIAcuity provides precise, binary results by counting the presence or absence of DNA molecules, resulting in a low error rate and the high precision necessary for courtroom testimony.
FDA clears Vidas TBI
The Food and Drug Administration issued 510(k) clearance to the BioMérieux Vidas TBI (GFAP, UCH-L1), a serum-based test to support the assessment of patients with mild traumatic brain injury, including concussion. The assay’s commercial launch in the United States is planned for the second half of this year.
FDA approves Imdelltra
The Food and Drug Administration approved Imdelltra (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. Imdelltra received accelerated approval based on the response rate and duration of response observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials.
Imdelltra is the first DLL3-targeting bispecific T-cell engager therapy that activates the patient’s own T cells to attack DLL3-expressing tumor cells.