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In Brief This Week: BGI, 10x Genomics, Abbott, Danaher, Guardant, and More

NEW YORK – BGI Americas said this week it that has received authorization from Health Canada under an interim order to market its Real-Time Fluorescent RT-PCR kit for SARS-CoV-2 detection in Canada. The kit is part of an integrated solution that includes MGI's MGIEasy Nucleic Acid Extraction Kit, which is included as a validated method for RNA extraction in the authorization, and the MGISP-960RS Automated Sample Preparation System. The test can return results within three hours, works with a range of respiratory samples, and has been validated on different RT-PCR instruments, the company said.

A US federal court judge last week denied 10x Genomics' motion to dismiss a patent infringement suit brought by Bio-Rad Laboratories in September 2019.

"At the motion to dismiss stage a complaint generally will only be dismissed where it is entirely implausible or impossible for the grouped defendants to have acted as alleged," Judge William Young of the US District Court for the District of Massachusetts wrote in the order dismissing 10x's motion on April 30. “Bio-Rad need only put 10x on notice of the infringement alleged and nudge their claims into the range of plausibility. They have done so."

The court also moved the venue of the lawsuit to the Northern District of California, saying it would be more convenient. Both 10x and Bio-Rad are based in the San Francisco Bay Area. This is the second time the case has been moved; originally the case was filed in the District of Delaware but was moved in December to Massachusetts.

Abbott said that research published in the Journal of Clinical Microbiology showed that its SARS-CoV-2 IgG lab-based serology blood test had 99.9 percent specificity and 100 percent sensitivity for detecting the IgG antibody in patients 17 days or more after symptoms began. The research was conducted by the University of Washington School of Medicine in Seattle. The test was granted Emergency Use Authorization by the US Food and Drug Administration a couple of weeks ago. 

Rutgers University's RUCDR Infinite Biologics on Thursday received an amended emergency use authorization from the US Food and Drug Administration for its SARS-CoV-2 test that will allow individuals to collect their own saliva sample at home and send it to the lab for testing. Up until now, healthcare workers had to collect patients' saliva at testing sites.

"The impact of this approval means that not only do we no longer have to put healthcare professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections, we can now preserve precious PPE for use in patient care instead of testing and can significantly increase the number of people collected each and every day in places other than a healthcare setting," said Andrew Brooks, chief operating officer and director of technology development at RUCDR, in a statement.

Rutgers was the first laboratory to obtain FDA EUA for a saliva-based SARS-CoV-2 test last month.

Danaher announced this week that its board approved a quarterly cash dividend of $.18 per share of common stock, payable July 31 to shareholders of record on June 26. The company’s board also approved a quarterly cash dividend of $11.875 per share of its 4.75 percent Series A Mandatory Convertible Preferred Stock, payable July 15 to shareholders of record on June 30.

Guardant Health this week launched a new effort it calls the Clear Your View campaign intended to raise awareness of the importance of comprehensive biomarker testing in guiding initial treatment decisions for newly diagnosed advanced non-small cell lung cancer (NSCLC) patients. The campaign is being supported by several national patient advocacy groups, including the GO2 Foundation for Lung Cancer, the LUNGevity Foundation, and ALK Positive. Current guidelines call for testing of multiple genomic biomarkers in NSCLC patients, but many still fail to receive testing of even the most established genes.

Guardant also argued that comprehensive genomic analysis is even more critical in the context of the current coronavirus pandemic, considering that targeted therapy options, if appropriate, are often easier or more convenient to administer to patients. The company’s Guardant360 assay is a blood-based liquid biopsy test, which it said offers both easier, non-invasive sample collection and faster turnaround than a test that requires a tumor tissue biopsy.

Peach State Health plan announced a collaboration with Quest Diagnostics to increase access to real-time reverse transcription PCR COVID-19 testing in critical areas of need Georgia. Through this collaboration, Peach State Health Plan will facilitate the distribution of approximately 1,000 Quest COVID-19 test kits each week to Federally Qualified Health Centers (FQHCs), including The Family Health Centers of Georgia, headquartered in Atlanta, and Curtis V. Cooper Primary Health Care, headquartered in Savannah. The FQHCs will conduct testing as part of a broader initiative to test persons who are symptomatic and asymptomatic in our underserved communities.

South Korean company Bioneer said this week that it will supply $5.7 million COVID-19-related instruments and kits to National Unified Procurement Company, State Enterprise Aramco, and King Fahd Medical Research Centre in Saudi Arabia. Since obtaining export approval on March 31, Bioneer said it has been supplying COVID-19-related products to 47 countries. It has a $1.9 million contract with Romania and $4 million contract with Qatar.

Ubiquitome said this week that it has received NZ$528,927 ($324,388) from the government of New Zealand to help increase the manufacturing capacity of its Liberty16 rapid COVID-19 testing device in Auckland. The Liberty16 is a real-time PCR device that connects via Bluetooth to its own proprietary iPhone App. It is battery-operated and weighs 2.5 kg, making it one of the smallest real-time PCR systems on the international market. The mobile device could be used in places like airports to pre-screen international travelers once borders reopen, the company said.

Ubiquitome has already sold Liberty16 to research and clinical labs in Japan, the US, Canada, the UK, and Germany. The company said it plans to apply for Emergency Use Authorization from the US Food and Drug Administration.

Co-Diagnostics said this week that regulators in Mexico have approved its Logix Smart Coronavirus COVID-19 Test for sale in the country. The Mexican Department of Epidemiology approved the test after it concluded an evaluation of its sensitivity, specificity, and non-reactivity with other respiratory viruses. The US Food and Drug Administration issued Emergency Use Authorization for the test in early April. The firm added that the Indian Council of Medical Research evaluated CoSara’s Saragene COVID-19 test kit and cleared it for sale in India.  CoSara, Co-Diagnostics' joint venture for manufacturing in India, now expects to begin filling orders for the test.

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.