NEW YORK – Mayo Clinic Laboratories announced last week that it will offer Lucence’s Liquid Hallmark NGS liquid biopsy assay for circulating tumor DNA and RNA across various cancers. The move is part of Lucence’s continuing effort to expand international access to its testing services.
Spear Bio said this week that its pTau 217 blood test has been granted breakthrough device designation by the US Food and Drug Administration. The test uses a wash-free workflow built on real-time PCR technology and is intended to be used as an aid in diagnosing Alzheimer’s disease.
PreludeDx said this week that the US Food and Drug Administration has granted the firm's DCISionRT test breakthrough device designation. The test is for evaluating a breast cancer patient's potential risk and benefit from radiation therapy. Specifically, it is used for patients with ductal carcinoma in situ breast cancer and combines tumor biology with clinicopathologic factors for personalized results. DCISionRT analyzes seven protein biomarkers and four clinical factors for a Decision Score that physicians can use to identify those patients who may benefit from radiation therapy and reduce over- and undertreatment, the Laguna Hills, California-based firm said.
ERS Genomics said this week that it is now offering small research enterprises and startups affordable and rapid access to its CRISPR-Cas9 patent portfolio through its Express License platform. Nonexclusive licenses for internal research use are now available to companies with fewer than 15 employees and less than $10 million in funding through the platform. Applicants can secure a license by demonstrating their eligibility through scientific credentials such as research publications, academic collaborations, or technology-related patents.
San Diego-based Aspen Neuroscience this week said it has completed dose escalation in the first two cohorts of Parkinson's disease patients being treated with ANPD001 within the open-label Phase I/IIa ASPIRO trial, which launched last year. ANPD001 is an autologous neuronal cell replacement therapy, which is designed to replace cells that have been lost or damaged due to moderate-to-severe Parkinson's disease. The company is now advancing the ANPD001 program to investigate its new commercial formulation of the cell replacement therapy.
Adaptimmune said this week that the US Food and Drug Association has granted breakthrough therapy designation to the firm's autologous T-cell receptor (TCR) T-cell therapy, letetresgene autoleucel (lete-cel) as a treatment for advanced, previously treated myxoid/round cell liposarcoma patients whose cancers express the NY-ESO-1 antigen and who are positive for human leukocyte antigen (HLA) type HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06. Drugmakers whose candidates have breakthrough therapy designation are eligible for more intensive guidance from the FDA as well as a dedicated scientific liaison to help accelerate review time. These agents also have the potential to receive priority review, contingent on meeting certain criteria.
Population genomics and precision health company Helix said this week that TriHealth, Parkview Health, and Rochester Regional Health have joined its Helix Research Network. Each of these health systems plans to enroll 100,000 volunteer participants in the effort, who will receive genetic risk information for conditions such as inherited breast and ovarian cancer, colorectal cancer, and high cholesterol. According to Helix, the health systems will also be able to bring new clinical trials and translational research to their communities through their participation.
Cerca Biotech and Shuwen Biotech said this week that MammaTyper, Cerca's breast cancer molecular subtyping assay, has been included in guidelines for breast cancer diagnosis and treatment by the Chinese Medical Association (CMA) and the China Anti-Cancer Association (CACA). MammaTyper uses real-time PCR to quantify mRNA levels for the breast cancer biomarkers ER, PgR, HER2, and Ki-67 in tumor biopsies or surgical samples to subtype the cancer according to St. Gallen guidelines. The kit has the CE mark, is approved by China's NMPA, and is distributed in China by Shuwen Biotech.
BGI Genomics said this week that the Brunei Ministry of Health, in partnership with the company, launched a new National Cervical Cancer Prevention and Control Program along with the 2025 National Guideline to help boost early detection and treatment of cervical cancer across Brunei.
The updated guideline recommends HPV DNA-based testing as a primary tool for early cancer detection. Accordingly, the cancer prevention and control program incorporates a national HPV DNA screening initiative for all women aged 25 to 65. According to BGI Genomics, the HPV self-sampling kits are available at 32 clinics, four hospitals, and three gynecology wards in Brunei's four districts.
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.