NEW YORK – The College of American Pathologists this week released a new proficiency testing program for the detection of SARS CoV-2. The program will provide samples that are non-infectious and target consensus regions N, E, RdRp, and ORF1a. The program will also allow laboratories to assess their entire workflow from nucleic acid extraction through detection.
Invitae this week closed an underwritten public offering that netted approximately $172.5 million after deducting discounts, commissions, and other expenses. In a filing with the US Securities and Exchange Commission, Invitae said it sold 17.8 million shares of common stock at $9.00 per share. The company also sold all 2.7 million shares that were an additional option for underwriters to exercise.
The company also said in the SEC filing that it has completed its acquisitions of YouScript and Genelex. Invitae had announced these acquisitions in March, and said it would pay $79.3 million for YouScript, including $25 million in cash and common stock, and $20.7 million for Genelex using shares of its common stock and additional shares if certain milestones are met.
At the closing of the YouScript transaction, Invitae issued 1.8 million shares of its common stock at $0.0001 par value per share and paid approximately $23.6 million in cash to the company’s former security holders. Invitae may pay an additional 460,455 shares and approximately $1.4 million in cash, but this is subject to a hold-back to satisfy indemnification obligations. In closing the Genelex transaction, Invitae issued 808,142 shares of common stock to the former security holders of the firm, and may pay an additional 66,681 shares, which are being held back to satisfy indemnification obligations.
CareDx this week announced the launch of the COVID-19 Transplant Registry (C19TxR.org), a registry run through the company’s OttrCare platform aimed at providing users with data on the impact of COVID-19 on immunosuppressed transplant recipients. The registry site will be free to use, open access, and web-based, with a real-time analytics dashboard for users to engage in best practices for COVID-positive transplant patient management, the company said.
The company also said this week that it has launched a service called RemoTraC to provide blood draws of routine transplant tests at home. The company launched RemoTraC in response to the COVID-19 pandemic. Transplant patients are immunosuppressed and a high-risk group for the disease, prompting some to cancel or delay appointments for routine lab tests.
Under a collaboration with Quest Diagnostics subsidiary ExamOne, 10,000 medical phlebotomists will now provide home blood draws for enrolled RemoTraC patients. More than 140 transplant centers around the US are now in the process of offering RemoTraC to their patients, and more than 1,000 kidney, heart, and lung transplant patients have enrolled online, the company said.
DNAe said this week that it has received Breakthrough Device designation from the US Food and Drug Administration for its LiDia-SEQ platform and first assay. The sequencing platform is a compact device operable by non-specialist users. The operation process is automated in a cartridge-contained, hands-free format, and can be used in diverse environments, the company said. The technology is based on semiconductor sequencing, which uses a silicon chip to detect ions released in the step-by-step construction of nucleic acids.
The company is aiming to develop a pipeline of rapid and cost-effective tests, including for infectious disease diagnostics, cancer, and infection control. The first assay, which is now available, is a test for bloodstream infections and antimicrobial resistance to detect and identify infections that can lead to sepsis.
Life sciences software company Discngine said this week that pharmaceutica company Sosei Heptares has chosen Discngine 3decision software to be part of a structural G protein-coupled receptor (GPCR) chemogenomics platform. Sosei Heptares will use 3decision to merge the public Protein Data Bank (PDB) structures with internal unpublished GPCR structures used for structure-based drug discovery, allowing it to combine its structural information, sequence information, and knowledge of chemical ligand space in GPCRs.
3decision will enable Sosei Heptares researchers to more efficiently derive structural GPCR insights from the structural data at hand, and to combine its structural information with GPCR modelling, cheminformatics capabilities, mutagenesis data, and the information provided by its Stabilized Receptor technology, Discngine said.
Fulgent Genetics said this week it has received temporary approval from the State of New York to perform COVID-19 testing on patient specimens from New York. The company had received a permit and genetic test approval from the New York Department of Health in 2019.
Danaher last week issued €150 million ($163 million) of 1.7 percent senior notes due 2024, €300 million of 2.1 percent senior notes due 2026, and €300 million of 2.5 percent senior notes due 2030 in an underwritten offering. The company received net proceeds of €753.7 million after deducting underwriting discounts and offering expenses. In a filing with the US Securities and Exchange Commission, Danaher said that it plans to use the funds for general corporate purposes, including potential repayment of some of its commercial paper borrowings or repayments of amounts borrowed under revolving credit facilities.
BC Platforms said this week that three European biobanks have joined BCRquest, the company's collaboration network for analyzing and viewing deidentified genomic and clinical data from multiple biobanks. The new participants are Generation Scotland in the UK, Bialystok Biobank in Poland, and Biobank Graz in Austria.
BCRquest acts as a type of matchmaker between biobanks and pharma companies to facilitate the design and implementation of clinical trials for novel therapies and drug targets. With the three new partners, the platform now contains nearly 3.5 million patient records across Europe and North America.
Novacyt said this week that the Centre National de Référence des Virus des Infections Respiratoires of the Institut Pasteur in France has approved its Primerdesign COVID-19 Genesig Real-Time PCR assay. The assay received CE Mark last month, and is now available for immediate distribution in France through Novacyt's distribution partner Atothis.
Novacyt also said this week that the assay has received approval from the Ministry of Health in Thailand. The test previously received accreditation from a number of global regulatory authorities, including Public Health England and the US Food and Drug Administration.
Chembio Diagnostics said this week that UNICEF has placed a second purchase order for $1.5 million of the firm’s multiplex Zika, chikungunya, and dengue (DPP ZCD) systems. The purchase order includes tests and micro readers. Chembio and UNICEF have a long-term arrangement (LTA), which also includes purchases of up to $2 million on top of the purchase commitment of $1.5 million. UNICEF previously placed a purchase order of $1.5 million for Chembio’s tests and micro readers in February, and along with the two purchase orders, the combined LTAs can total up to $7 million in potential orders, the company said.
Australian genetic testing firm Genetic Technologies announced this week the closing of its registered direct offering of more than 1 million American Depository Shares at A$1.75 ($1.06) per share. Each ADS represents 600 of the company's ordinary shares, and proceeds from the offering were $1.8 million.
Genetic Technologies said it plans to use the money to support distribution of its products in the US, to develop polygenic risk tests with the Translational Genomics Research Institute, to implement its consumer-initiated testing platform, and for working capital. HC Wainwright served as the exclusive placement agent for the offering.
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.