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In Brief This Week: Invitae, Danaher, Fulgent Genetics, and More

NEW YORK – Invitae on April 6 closed an underwritten public offering that brought in approximately $172.5 million in net proceeds. In a filing with the US Securities and Exchange Commission, Invitae said it sold about 17.8 million shares of common stock at a price of $9.00 per share. The offering's underwriters exercised their option to purchase an additional 2. 7 million shares..  

The company also said in the SEC filing that it has completed the acquisitions of YouScript and Genelex on April 1. Invitae had announced the 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. 


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. Danaher said in a report filed with the US Securities and Exchange Commission 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.   


Fulgent Genetics said this week it has received temporary approval from New York state to perform COVID-19 testing on specimens from the state. The company had received a permit and genetic test approval from the New York Department of Health in 2019.  


Novacyt said 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 into the French market 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 for 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, or 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 Hauppauge, New York-based company said.  

Separately, the company also said that Stony Brook Medicine has chosen its DPP COVID-19 serological point-of-care test in an initiative to recruit patients who have recovered from the disease. Stony Brook Medicine intends to conduct a study to assess whether convalescent blood plasma from recovered patients can be used to effectively treat hospitalized patients with COVID-19. Chembio's test is being used to confirm that patients were infected with SARS-CoV-2, the coronavirus that causes COVID-19, and subsequently have enough levels of IgG antibodies to make them eligible to donate convalescent plasma. 


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,ERdRp, and ORF1a. The program will also allow laboratories to assess their entire workflow from nucleic acid extraction through detection.   


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 aims 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.  


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 


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 360Dx.