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In Brief This Week: BGI, Gencove, Cepheid, Biocartis, Biognosys, Co-Diagnostics, More

NEW YORK – BGI Americas and Gencove said this week that they have extended their agreement to jointly offer low-pass whole-genome sequencing and analysis services. Their partnership, initiated more than three years ago, combines BGI's sequencing services using its DNBSeq sequencing technology with Gencove's data analysis platform. BGI Americas is the US subsidiary of China-based BGI Genomics. 

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. 

Swiss biotech company Biognosys said this week that its proteomics research facility received Good Laboratory Practice (GLP) certification for preclinical studies from the Swiss GLP Monitoring Authorities after an inspection. It also announced that it is fully compliant with Good Clinical Practice, as laid out by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. The GLP certification arose from a partnership with Roche and the setup of a quality management system to use discovery proteomics in clinical trials, 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. 

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. 

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.

The US government's Office of the National Coordinator for Health Information Technology this week opened applications for demonstration sites for the fifth phase of the Sync 4 Genes program. Phase 5 will focus on standardizing genomic variant sharing and interpretation among care providers, researchers, genomic laboratories, and knowledgebases. Groups wishing to participate in the demonstration have until Feb. 11 to fill out a site profile application on the ONC website. 

Enpicom said this week that it has closed a Series B funding round but did not disclose the value of the investment. BOP Capital led the round, which Enpicom said it would use to accelerate the scale-up of its ImmunoGenomiX (IGX) technology platform and to develop new product extensions to support antibody discovery, characterization, and development. The Dutch bioinformatics firm previously raised €1.2 million ($1.4 million) in a Series A round that closed in March 2019. 

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 GenomeWeb.