NEW YORK — 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.
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.
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.
Autoimmune diagnostic firm Exagen this week announced its financial results for Q4 and full-year 2024, reporting that its Q4 revenues declined slightly to $13.7 million from $13.8 million in Q4 2023. Full-year revenues rose 6 percent to $55.6 million from $52.5 million in 2023 on the strength of continued increases in the firm's average selling price per test. Net loss in the quarter was $3.8 million, or $.20 per share, compared to net loss of $5.6 million, or $.31 per share, in Q4 2023. Net loss for the year totaled $15.1 million, or $.83 per share, compared to net loss of $23.7 million, or $1.34 per share, in 2023. Exagen ended the year with $22.0 million in cash and cash equivalents.
The firm anticipates revenues of at least $14.5 million in Q1 2025 and expects to deliver positive adjusted EBITDA in the fourth quarter of 2025.
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.
ARC Regulatory, a precision medicine clinical trial support and research compliance firm based in Belfast, Ireland, this week announced the launch of a new laboratory services division. The expansion was supported by £3 million ($3.8 million) in self-funded investment and is intended to further strengthen ARC's capabilities in assay validation, clinical trial sample testing, and clinical performance studies for complex in vitro diagnostic tests.
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.
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 360Dx.