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In Brief This Week: Biocept, SeqLL, Castle Biosciences, VolitionRx, More

NEW YORK – 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. 

Single-molecule sequencing technology firm SeqLL this week reported a 36 percent decrease in 2021 revenues, to $209,995, compared to revenues of $329,495 in 2020, driven by a decline in grant revenue.

Net loss for the year was $3.7 million, or $.51 per share, compared to a net loss of $1.1 million, or $.21 per share, in 2020. The weighted average number of shares in 2021 was approximately 7.2 million, compared to 4.9 million in 2020.

R&D expenses grew 60 percent in 2021 to $530,076 from $330,979 the year before, while SG&A expenses nearly tripled to $2.2 million from $777,435.

The firm ended 2021 with $4.0 million in cash and cash equivalents and $5.9 million in marketable securities. It did not report separate fourth quarter results. Since Monday, shares of SeqLL have been trading down more than 20 percent on the Nasdaq. 

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. 

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. 

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. 

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. 

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. 

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.