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In Brief This Week: Cepheid, Biocartis, Sight Diagnostics, Fluidigm, Co-Diagnostics, and More

NEW YORK – Last month, the US Food and Drug Administration revoked the Emergency Use Authorization for Cepheid’s Xpert Omni SARS-CoV-2 real-time PCR test upon the company’s request. According to Cepheid, the current public clinical needs are being met by the firm’s other available EUA tests, and the company hasn’t commercially distributed any of the Xpert Omni tests as a result. The test received EUA in November 2020.

Biocartis said this week that it has placed 331 new Idylla real-time PCR instruments in 2021, in line with its prior guidance of between 300 and 350 new instrument placements. The total installed base for Idylla as of Dec. 31 was 1,912 instruments. The firm added that it sold 323,000 commercial cartridges last year, a 40 percent increase from 2020. At the end of 2021, it had €53.5 million ($60.6 million) in cash.

Sight Diagnostics said this week that it has received Health Canada approval to provide its Sight OLO analyzers for complete blood counts in point-of-care settings. Its partner Inter Medico will distribute the analyzers in emergency departments, hospitals, and other decentralized settings across Canada, Sight Diagnostics added. Using the analyzer, patients can draw blood from a finger prick and receive five-part differential CBC results in minutes, the company said. Sight Diagnostics previously received Health Canada approval to distribute the analyzer in laboratories. The analyzer is also CE marked and has received 510(k) clearance from the US Food and Drug Administration.

Rover Labs said this week that it is providing saliva-based SARS-CoV-2 PCR testing to New Jersey public schools using Fluidigm’s tests. Rover Labs began testing students, teachers, and staff at K-12 public schools in Atlantic, Cape May, Cumberland, Monmouth, and Sussex counties in October and will continue testing for a full year, the firm said in a statement. Users provide saliva samples with a self-collection kit overseen by the lab’s sample collection supervisors and receive the results on their smartphones, the company said.

Co-Diagnostics said this week that its Indian joint venture CoSara Diagnostics has received clearance from the Central Drugs Standard Control Organization in India to manufacture and sell its Saragene Human Papillomavirus High-Risk Real-Time PCR test as an in vitro diagnostic. The multiplex test is built on the company's patented CoPrimer technology and is designed to detect and differentiate between HPV genotypes 16 and 18, while simultaneously detecting high-risk carcinogenic HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. It is the 12th CoSara assay to receive CDSCO approval, Co-Diagnostics said.

Australian molecular diagnostics company Genetic Signatures said this week that Australia's Therapeutics Goods Administration recently registered a saliva-based protocol for collecting and testing patient samples for SARS-CoV-2 using the company's 3base EasyScreen SARS-CoV-2 Detection Kit. Genetic Signatures highlighted a recently posted MedRxiv preprint that determined that saliva swabs may be the preferred sample type for Omicron variant detection.

Genetic Signatures also noted that it recently launched the research-use-only EasyScreen SARS-CoV-2 Detection Kit designed to detect and differentiate all known viral variants, including Omicron, using the same 3base real-time PCR technology.

The College of American Pathologists has accredited the lab of Dot Laboratories (DotLab), the firm said this week. The designation was based on results from a recent inspection as part of CAP's accreditation programs.

Streck said this week that it has partnered with Ceres Nanosciences to distribute that company's Nanotrap Magnetic Virus Particles that measure rapid viral concentration directly from raw sewage for wastewater-based COVID-19 surveillance. Traditional methods for determining the concentration of virus from wastewater are time-intensive and require materials under supply constraints or instrumentation that takes hours to produce results, Streck said. Ceres' particles circumvent these issues, reducing the time and effort to process wastewater samples, and are compatible with many commercially available RNA extraction kits and detection methods, including reverse transcription qPCR, reverse transcription droplet digital PCR, and viral genome sequencing.

Pharmacy benefit manager WellDyne will use BostonGene's cancer tumor profiling test to identify which patients with non-small cell lung, gastric, kidney, bladder, and skin cancers are eligible for immunotherapy, the companies said this week. Under a strategic collaboration between the two firms, Lakeland, Florida-based WellDyne will use BostonGene's Molecular Functional Portrait, an offering within its Tumor Portrait Tests, to gain insights into which patients are likely to benefit from immunotherapy. Waltham, Massachusetts-based BostonGene's Tumor Portrait Tests integrate genomic and transcriptomic analysis and identify the molecular, immune, and microenvironment properties driving patients' tumors.

WellDyne hopes to improve management of the total cost of care for cancer patients by implementing these tests, including Molecular Functional Portrait. BostonGene inked a similar partnership with NEC last year that allowed it to begin offering Tumor Portrait Tests to cancer patients in Japan.

Deep Lens and Hematology-Oncology Associates of Central New York this week announced a collaboration to improve clinical trial matching and expand the oncology practice's clinical trial program. Deep Lens' technology platform, called VIPER, will prescreen all patients in the medical record system of Hematology-Oncology Associates of Central New York, which has four locations in the state. It will integrate pathology and molecular data feeds from Caris Life Sciences, Guardant Health, and Foundation Medicine to automatically identify qualified patients for clinical trials.

ProPhase Labs said this week that it conducted more than 300,000 COVID-19 PCR tests in Q4 2021, a new record for the company that exceeded its expectations. The firm also increased its headcount to more than 250 laboratory professionals in the quarter, from a previous number of 50 lab professionals in Q3.

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.