NEW YORK – Count Me In, a patient-partnered research initiative led by the Broad Institute and Dana-Farber Cancer Institute, said this week that it is launching a new project that focuses on translocation renal cell carcinoma (tRCC), a rare and aggressive form of kidney cancer that involves chromosomal translocations. The study will encourage tRCC patients to share their health data and biological samples with scientists in a de-identified manner. The researchers plan to use genomic sequencing and other tools at Broad Clinical Labs to explore tRCC at the molecular level. The project is open to anyone in the US and Canada who has been diagnosed with tRCC.
TeleRare Health and Frederick Health said this week that they are partnering to expand patient access to genetic testing, diagnosis, and care for rare and genetic diseases. Patients needing an evaluation to determine whether they should receive genetic testing can now be seen within the Frederick Health system, patients will no longer be on lengthy waitlists, and genomics-informed medical care will be integrated into their standard healthcare without changes to existing services and workflows, according to the partners.
Epigenetics firm VolitionRx said this week that it has enrolled the first patient in a clinical study called "Epigenetic Nucleosomes in Plasma for Pulmonary Nodule Differentiation." The prospective study, conducted in collaboration with National Taiwan University Hospital, is evaluating VolitionRx's Nu.Q Cancer blood-based test for distinguishing between malignant and benign pulmonary nodules in patients undergoing lung cancer screening with low-dose computed tomography. It plans to enroll 500 patients and is expected to be completed this year.
Ascentage Pharma said this week that China's National Medical Products Administration (NMPA) granted breakthrough therapy designation to its BCR-ABL1/KIT inhibitor olverembatinib with low-intensity chemotherapy as a first-line treatment for newly diagnosed Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia. Ascentage, which markets olverembatinib with Innovent Biologics, is studying the drug in a Phase III trial in the first-line Ph-positive acute lymphoblastic leukemia setting. Olverembatinib was approved in China in 2021 for tyrosine kinase inhibitor-resistant chronic-phase chronic myeloid leukemia or accelerated-phase CML harboring T315I mutations.
The US Food and Drug Administration has granted Atsena Therapeutics fast-track designation for ATSN-201, a gene therapy that it's developing for X-linked retinoschisis, the Durham, North Carolina-based company said this week. Atsena is currently evaluating the safety and tolerability of ATSN-201 in the Phase I/II LIGHTHOUSE trial. With fast-track designation, a sponsor can meet with the FDA more frequently to get advice on developing fast-track designated agents, submit data on a rolling basis, and apply for accelerated approval or priority review.
Cancer detection and monitoring firm ClearNote Health said this week that the company has inked an agreement with healthcare tech firm Claritev to make ClearNote's laboratory-developed test for the early detection of pancreatic cancer available through Claritev's national Private Healthcare Systems and Multiplan PPO networks. The blood-based Avantect Pancreatic Cancer Test is used for the detection and algorithm-based analysis of the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA along with genomic markers of pancreatic cancer in patients who are at elevated risk of the disease. ClearNote said that the test aids the early detection of cancer by identifying biological changes related to tumor development.
Allarity Therapeutics has reached a settlement with the US Securities and Exchange Commission relating to an investigation around its interactions with the US Food and Drug Administration about a new drug application for its tyrosine kinase inhibitor dovitinib, which it was developing with a drug response predictor tool in advanced renal cell carcinoma in 2021. Under the terms of the settlement, announced this week, Allarity has consented to the entry of an administrative cease-and-desist order without admitting or denying the SEC's findings. As part of the settlement, Allarity will pay a one-time civil penalty of $2.5 million and will cooperate with the SEC in any related litigation.
PreventionGenetics, a subsidiary of Exact Sciences, said this week that it is the new administrator of Alnylam Act, a no-cost genetic testing program sponsored by Alnylam Pharmaceuticals that provides testing for acute hepatic porphyria, primary hyperoxaluria type 1 (PH1), and hereditary ATTR (hATTR) amyloidosis. The tests are performed using next-generation sequencing and additional Sanger sequencing as necessary. Besides testing, the program offers pre- and post-test genetic counseling services through Genome Medical.
The Nevada legislature introduced a bill this week to expand the state’s biomarker coverage mandate. If passed, SB344 would require insurers to cover noninvasive prenatal screening for biomarkers related to a variety of genetic disorders, in addition to the currently mandated cancer-related biomarkers. Coverage for such screening under this bill would not require prior authorization.
Mayo Clinic Laboratories and precision medicine firm Kyan Technologies announced this week that they would together validate and provide the Kyan Optim.AI test across the US. Optim.AI is an ex vivo drug sensitivity platform that combines small data artificial intelligence and biological experiments to provide insights into effective therapies for cancer patients and deliver efficiencies in cancer drug development. The test features drug plates that include multiple drugs and requires minimal amounts of biological material. Mayo Clinic Laboratories will make the test available to physicians and researchers who can use it to identify better treatment options for patients and glean insights that improve drug development.
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.