NEW YORK – Swedish in vitro diagnostics company Devyser said this week that it has secured a tender for its Devyser CFTR next-generation sequencing cystic fibrosis test with Italian hospital Policlinico di Bari for five years with an estimated total order value of up to SEK 5.4 million (about $500,000). Devyser CFTR is a CE IVD-marked test that captures all clinically relevant cystic fibrosis gene mutations in a single assay to confirm a cystic fibrosis diagnosis and to screen for genetic variants in newborns and adults.
Danaher subsidiary Beckman Coulter Diagnostics announced this week that its Access p-Tau217/β-Amyloid 1-42 Plasma Ratio blood test has received breakthrough device designation from the US Food and Drug Administration. The test is intended to help clinicians identify patients who have amyloid pathology associated with Alzheimer's disease. The assay measures the ratio of phosphorylated tau protein (p-tau 217) to βAmyloid 1-42, two biomarkers associated with the neurodegenerative processes of Alzheimer's disease.
In 2023, Beckman Coulter announced a partnership with Fujirebio to develop blood-based immunoassays for Alzheimer's.
London-based Beacon Therapeutics this week said that the US Food and Drug Administration has granted regenerative medicine advanced therapy designation to laruparetigene zovaparvovec, abbreviated as laru-zova and previously known as AGTC-501, which is a gene therapy that the company is developing for X-linked retinitis pigmentosa caused by mutations in the RPGR gene. The FDA awarded the designation based on preliminary clinical evidence from the Phase II DAWN and SKYLINE trials of the gene therapy, which is the company's lead candidate.
Health and research company Care Access this week offered free health screenings in Brownsville, Texas, to identify heart and kidney health risks for patients. The free health screening included testing for lipoprotein(a), a cardiovascular risk factor, as well as tests for other metabolism and kidney risks. The effort is part of the organization's Future of Medicine program, in which it provides free testing and health education and connects participants with clinical research opportunities.
IASO Biotherapeutics this week said the Singapore Health Sciences Authority accepted a new drug application for the CAR T-cel therapy FUCASO (equecabtagene autoleucel) as a treatment for patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy. FUCASO is a fully human anti-BCMA CAR T-cell therapy already approved in China. It is made using a lentiviral gene vector to transfect autologous T cells.
Brandon Shippy, a Republican state senator in Idaho, this week introduced a bill in the Idaho Legislature that would establish a moratorium on healthcare practitioners' ability to administer "gene therapies" in certain cases, specifically "for any infectious disease indication, regardless of whether such administration is termed an immunization, vaccine, or any other term." The proposed bill would prohibit "gene therapy immunizations" and "protect Idaho adults and children from the adverse effects of experimental gene therapy and biologic products utilized as immunizations," according to the text of the bill that Shippy posted on X, the social media platform previously known as Twitter.
The proposed bill is designed to prohibit mRNA vaccines that protect against COVID-19, and which incorrectly have been conflated with gene therapies, according to the Idaho Statesman. The proposal carves out exceptions for gene therapies for cancers and genetic disorders.
The US Food and Drug Administration this week granted orphan drug designation to March Biosciences’ autologous CAR T-cell therapy, MB-105, for the treatment of relapsed or refractory CD5-positive T-cell lymphoma. March, which spun out from Baylor College of Medicine, is currently studying MB-105 in a Phase I clinical trial for T-cell lymphoma and T-cell acute lymphoblastic leukemia and expects to begin a Phase II trial of MB-105 in early 2025. The FDA grants orphan designation to drugs for rare diseases, which provides sponsors tax credits for clinical trials, exemption from user fees, and seven years of market exclusivity for the drug after regulatory approval.
Guardant Health has inked an agreement with the Abu Dhabi Public Health Centre (ADPHC) to introduce a noninvasive blood-based screening program for colorectal cancer using Guardant’s Shield test, a methylation-based assay designed to detect cancer-associated signals in cell-free DNA that circulates in the blood. Hikma Pharmaceuticals, a regional partner for Guardant in the Middle East and North Africa, set up the partnership. The M42 healthcare system, a collection of advanced health facilities headquartered in Abu Dhabi, will serve as its administrator.
Under the agreement, Shield testing will be provided as part of the ADPHC’s IFHAS comprehensive health screening program and will be available at healthcare facilities across Abu Dhabi, Al Ain, and the Al Dhafra region. The partners aim to screen approximately 10,000 individuals in the program's first year and expect the availability of blood-based screening to help resolve low adherence rates for existing recommended screening tools like colonoscopy. Financial terms of the deal were not disclosed.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) this week said it's been asked by the European Commission to consider safety data on Eisai and Biogen's Leqembi (lecanemab) that became available after the committee adopted a positive opinion on the drug in November, reversing a previous decision from July. The EC is asking the CHMP to consider whether the new information requires it to update its opinion or the wording of risk minimization measures it included. The CHMP will provide a response to the EC after its plenary meeting in February.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on Precision Medicine Online.