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.
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.
CareDx said this week that its AlloSure test has been approved by the New York state Clinical Laboratory Evaluation Program (CLEP) for two additional indications: pediatric heart transplant patients of all ages and patients who have received a simultaneous pancreas-kidney (SPK) transplant.
German molecular diagnostics and rare disease company Centogene said this week that it has closed the sale of its operating subsidiary to an affiliate of Charme Capital Partners. Last November, the firm had announced its intent to sell its business to Charme for €8.7 million ($9.5 million) in cash. Under the agreement, Charme would acquire Centogene GmbH, the firm's sole operating subsidiary, and assume Centogene’s loan from Oxford Finance. Centogene shareholders voted in favor of the sale in early December. Following the closing of the deal, Centogene and its subsidiary Centogene Switzerland will no longer have any operations. The company plans to liquidate Centogene Switzerland and to make a liquidation distribution to its shareholders. It expects that its securities will cease to be quoted on the OTC market soon.
Bioinformatics firm Golden Helix said this week that it has signed a multiyear agreement with all five healthcare regions in Denmark. Under the agreement, the Bozeman, Montana-based company will provide its software to several laboratories to enhance their genomic capabilities. Financial and other terms of the deal were not disclosed.
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.
Cancer detection and monitoring firm ClearNote Health said this week that it 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 in the early detection of cancer by identifying biological changes related to tumor development.
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.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.