NEW YORK – Unilabs said this week that it has signed a deal with the International Air Transport Association to incorporate the company’s COVID-19 testing network into the IATA Travel Pass. The Travel Pass provides information about countries' entry requirements pertaining to COVID-19 testing and directs travelers to labs to get tested for the coronavirus. Through the Travel Pass app, travelers can receive digital certificates for COVID-19 tests or vaccinations. The partnership between Unilabs and IATA, a trade association for the world's airlines, allows travelers to access the Swiss diagnostics service provider's lab network and manage their test results, the company said. Unilabs will securely upload test results in the IATA Travel Pass, and the results are checked against the IATA global registry of national health requirements to produce an "OK to Travel" status. The partners are currently running a pilot program in the United Arab Emirates. When fully operational, the program will be rolled out to other Unilabs entities in other countries, they said.
PerkinElmer said this week that it will be a provider and codeveloper of assays, instruments, and expertise for the Proxidrugs Consortium, which is researching proximity drugs, or proteolysis targeting chimeras, a new class of drugs that use a body's cell protein recycling system to fight disease. The consortium is being led by Goethe University in Germany and expects to start its research projects in October. It aims to put disease-relevant proteins close to key enzymes so that they can be targeted for destruction and recycled by the cells' natural shedding abilities. Waltham, Massachusetts-based PerkinElmer will provide its no-wash AlphaLisa and HTRF immunoassay technologies and expertise in protein labeling, as well as assay design. It also will provide its EnVision multimode plate readers, high-content imaging technologies such as the Opera Phenix and Operetta CLS platforms, and data analysis and informatics tools such as Tibco Spotfire software.
AstraZeneca, Loxo Oncology, and Invitae this week joined the Access to Comprehensive Genomic Profiling Coalition, a group that advocates for US health insurers to cover comprehensive genomic profiling for cancer patients. The coalition also educates health insurers and other healthcare stakeholders about the clinical utility and value of comprehensive genomic profiling for all tumor types. The coalition's full members comprise diagnostics companies and laboratories, including Exact Sciences, Foundation Medicine, Illumina, Laboratory Corporation of America, NeoGenomics, Qiagen, Roche, Tempus, and Thermo Fisher Scientific. Invitae joined the coalition as a full member, and AstraZeneca and Loxo joined as associate members.
Becton Dickinson said this week that it has partnered with USA Track & Field to provide rapid COVID-19 testing for USATF athletes with the BD Veritor Plus system. Testing will be conducted at multiple events during the Journey to Gold – Tokyo Outdoor Track & Field Series to help keep athletes safe as they seek to qualify for the US Olympic Team Trials ─ Track & Field. For the US Olympic Team Trials, USATF requires pre-travel testing. Athletes, coaches, officials, agents, medical staff, meet management staff, and others will also be tested every two days during the trials using the BD Veritor COVID-19 rapid antigen test and additional PCR tests.
Seegene said this week that it is supplying its Allplex SARS-CoV-2 tests to National Services Scotland, or NSS, under a £16.2 million ($22.4 million) public procurement agreement. NSS will supply the tests to nine hospitals, including Royal Infirmary Edinburgh and Ninewells Hospital, starting in April. Seegene noted that it also secured a public procurement deal in Italy worth €89.3 million.
OpGen said this week that it has extended its collaboration with the New York State Department of Health to develop solutions to detect, track, and manage antimicrobial-resistant infections at healthcare institutions in the state. The collaboration has been extended by six months to Sept. 30. The parties originally reached an agreement in 2019, then expanded it in 2020.
The Gaithersburg, Maryland-based company noted that it has achieved all the milestones of the first- and second-year phases for the development of an infectious disease digital health and precision medicine platform connecting healthcare institutions to the NYSDOH, while using genomics-based microbiology to survey and control antimicrobial resistance in the state. OpGen will continue to work with NYSDOH's Wadsworth Center and participating healthcare systems to increase the platform's reach and testing volume and enhance data collection.
OpGen also said that due to the COVID-19 pandemic, testing slowed down in 2020, and the extension and expansion of the collaboration will allow stakeholders to generate more data as testing volumes have increased "substantially" since last fall. The company offers its Acuitas AMR Gene Panel and Acuitas Lighthouse Software for high-resolution pathogen tracking. It said that the six-month extension and expansion contract will provide it a quarterly retainer-based project fee and volume-based per test fees for a total contract value of up to an additional $540,000.
NorthShore University HealthSystem and Sema4 said this week that they have partnered to launch a genomics program that will use predictive analytics to help prevent, detect, and treat diseases at an early stage. As part of the program, NorthShore clinicians and patients will have access to Sema4's genomic products for hereditary cancer, cardiovascular diseases, pharmacogenomics, and rare diseases. Sema4's technology combines clinical information with genomic analysis to understand how genetic variants will influence a patient's risk of developing disease. Patients can also consent to share their data with researchers. NorthShore will subsidize genetic testing for patients who cannot pay for it through a gift from the Swedish Hospital Foundation. Earlier this month, NorthShore started offering the program to patients of Swedish Hospital, a safety net hospital in Illinois that is in a medically underserved area.
XPhyto Therapeutics said this week it has signed an agreement with an unnamed German pharmaceutical wholesaler and service provider for the distribution, storage, and logistics of XPhyto's diagnostics products in Germany, including its SARS-CoV-2 RT-PCR test system. The system is registered in the EU as a commercial in vitro diagnostic test. Financial and other terms of the deal were not disclosed.
XPhyto's system is a multiplex viral RNA probe kit that requires a single 20-minute PCR thermal cycle. Prior RNA extraction is not required as part of the sample preparation, the Vancouver, British Columbia-based firm said, adding the test can be used with many widely available standard PCR instruments. The test is being launched in Europe this month. XPhyto said it is in discussions with potential customers, distribution and wholesale partners, and potential licensees for the test.
Quadrant Biosciences announced this week that its assay to detect markers of autism spectrum disorder has been granted Breakthrough Device Designation from the US Food and Drug Administration. The test, called Clarifi ASD, detects RNA epigenetic biomarkers in saliva samples and can be used along with patient characteristics to potentially enable earlier ASD diagnosis and treatment.
Oncocyte said this week that it has closed its acquisition of Chronix Biomedical. The deal brings Oncocyte a new commercial test candidate that it has dubbed DetermaCNI. The assay quantitatively measures copy number variation present in a cancer patient's blood as a measure of response, or lack thereof, to cancer immunotherapy. The terms of the acquisition include Oncocyte delivering $2.675 million in cash and $1.5 million of its common stock, or approximately 295,000 shares, at closing of the transaction.
MDxHealth said this week that it has amended its 2019 loan facility with Kreos Capital, extending the interest-only period from 18 months to 27 months. According to the company, this extends repayment of principal from May 2021 to February 2022. As part of the amendment, the firm has agreed to increase the end-of-loan fee by an additional $80,000. The agreement also provides for a portion of MDxHealth’s loan to be convertible into shares at a 25 percent premium to the 30-day volume weighted average price 10 days prior to signing the amendment. If exercised, this amount would then be reduced from the principal due under the loan agreement.
Yourgene said this week that it has been successful with its tender under PHE's National Microbiology Framework for Lot 4 (Clinical Laboratory Diagnostic Testing Services). Lot 4 is a £15 billion ($20.78 billion) framework required to be satisfied over a period of four years by multiple successful bidders, with only 50 companies appointed to this lot.
PHE's National Microbiology Framework is appointing suppliers to framework agreements for four lots, Yourgene said. Awards under Lot 1 and Lot 4 have been announced and cover the supply of diagnostics goods and services, including clinical laboratory diagnostic testing services. Yourgene also said this week that it had been successful with its tender for Lot 1.
Yourgene will be able to offer its Clarigene SARS-CoV-2 PCR assay and associated Manchester-based clinical laboratory testing services under the framework agreement.
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.