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In Brief This Week: Castle Biosciences, Roche, Biocept, Ellume, Accelerate Diagnostics, and More

NEW YORK – Castle Biosciences said this week that the Centers for Medicare & Medicaid Services has granted its TissueCypher Barrett’s Esophagus test Advanced Diagnostic Laboratory Test (ADLT) status, effective March 24. TissueCypher is a prognostic assay designed to predict future development of high-grade dysplasia or esophageal cancer in patients with Barrett’s esophagus.

ADLT status requires that a test provide new clinical diagnostic information that cannot be obtained from any other test or combination of tests, among other criteria. TissueCypher is Castle’s fourth test to receive this status, joining DecisionDx-UM, DecisionDx-Melanoma, and MyPath Melanoma.

Mursla this week announced a prospective pilot study to identify novel biomarkers that can detect early-stage liver cancer. The study, supported by Roche Diagnostics, will support development of a liquid biopsy assay. Mursla will analyze hundreds of blood samples using its multiomic exosome characterization platform, ExoPheno. The platform will identify exosome subpopulations for patients with chronic liver disease and cancer at various stages. The study and collaboration with Roche were started through Collaborate to Innovate: London Diagnostics, a program run by London-based life sciences nonprofit MedCity.

Molecular diagnostics firm Biocept this week reported preliminary 2021 net revenues of $61.2 million. The firm said it had approximately $28 million in cash and cash equivalents at the end of last year.

2021 revenues hit a record high, up 123 percent over the prior year, driven primarily by RT-PCR COVID-19 testing, Samuel Riccitelli, Biocept’s chairman, interim president, and CEO, said in a statement. "As anticipated, we are currently experiencing a decline in COVID-19 testing demand as the unpredictable pandemic begins shifting to an endemic stage," he said.

Biocept said it saw sequential-quarter volume growth in Q4 2021 for CNSide, its cerebrospinal fluid assay for the detection and monitoring of cancer involving the central nervous system.

The accounting review of Biocept’s financial statements for 2021 is ongoing, the firm noted. It has restated its financial results for the quarter ended Sept. 30, 2021, and implemented additional accounting review and control procedures.

Ellume said this week that it has opened a new 215,000-square-foot production facility in Frederick, Maryland. The company said the facility has the capacity to produce roughly 15 million COVID-19 home tests per month. Ellume began assembling tests at the facility in February. The site currently employs 200 people and will employ up to 1,500 when operating at full capacity. CEO Sean Parsons said the new facility will allow the company to significantly scale its COVID-19 test production while it is developing new testing products.

Accelerate Diagnostics said last week that it entered into a securities purchase agreement to sell 2,439,024 of its shares to the Schuler Trust for $1.64 per share, representing an aggregate purchase price of $4 million. In a filing with the US Securities and Exchange Commission, Accelerate noted that Jack Schuler, who serves as a member of its board, is the sole trustee of the Schuler Trust. The private placement is expected to close on June 30.

Dutch diagnostics firm PamGene said this week that it has received renewal and an amended scope of its ISO 13485:2016 certification from Dekra Certification. The standard certifies the quality of the company’s design, development, and manufacturing of in vitro diagnostic devices for the prediction of therapy response for cancer, PamGene said, adding that the expansion of the certification is an “important milestone” for the launch of its IOpener liquid biopsy immunotherapy response test. The company is preparing to launch IOpener test services in Europe and will use Dekra as its notified body under Europe’s forthcoming In Vitro Diagnostic Regulation requirements.

CareDx said this week that it will educate the European Society for Organ Transplantation on the clinical evidence supporting the use of the AlloSeq donor-derived cell-free DNA (dd-cfDNA) test in monitoring the health of transplanted organs. AlloSeq uses dd-cfDNA to monitor allograft injury and the risk of transplant rejection.

VolitionRx this week reported a 2021 net loss of $27 million, compared to a net loss of $20.4 million in 2020. The increase resulted mainly from noncash items and new staff hirings, the company said. As of Dec. 31, 2021, VolitionRx had $20.6 million in cash and cash equivalents.

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.