NEW YORK – Thermo Fisher Scientific said this week that it has certified the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to meet the European Union's new In Vitro Medical Devices (IVDR) requirements. The system has been updated and now includes the Applied Biosystems Diomni software ecosystem, which can connect multiple RT-PCR instruments and allows for secure data sharing across a user network. The QuantStudio 7 Pro Dx system is available in all regions that recognize CE-IVD certification. It is also listed as a Class II medical device with the US Food and Drug Administration.
DNAnexus said this week that it has won a three-year contract from Our Future Health to provide its platform for a large-scale health research program. Specifically, the company will offer approved researchers a scalable, cloud-based environment for accessing and analyzing data from Our Future Health, a collaboration between public, private, and nonprofit organizations that aims to recruit up to 5 million adult volunteers.
Cancer diagnostics firm Precipio said this week that it has signed a distribution deal with an undisclosed partner for its HemeScreen test for detecting hematologic malignancies. The new distributor is focused on a healthcare segment with a $100 million potential market opportunity, the New Haven, Connecticut-based firm said. In July, Precipio announced a distribution deal with Thermo Fisher Scientific's Fisher Healthcare for HemeScreen.
Delfi Diagnostics will serve as the liquid biopsy partner for the European, multinational lung cancer screening trial 4-IN-THE-LUNG-RUN, or 4ITLR, the company said this week.
In the trial, investigators are studying how often at-risk individuals should be screened if their initial CT scan is negative. Under the collaboration, Delfi will analyze the first 9,000 subjects enrolled in the trial in the Netherlands and France, aiming to assess whether its test can identify individuals who are most likely to benefit from more frequent CT scans. Financial terms of the collaboration were not disclosed.
Streck said this week that it has made a Series B investment of undisclosed size in Ceres Nanosciences. Ceres, based in Northern Virginia, plans to use the funds to accelerate the development and commercialization of diagnostic and research products that use its Nanotrap particle technology. Nanotrap particles capture, concentrate, and preserve low-abundance analytes from biological samples. A Streck spokesperson said the firm is the sole investor in Ceres’ Series B round.
Invitae and Simons Searchlight aim to get a deeper understanding of the etiology and progression of rare diseases through a data sharing agreement announced this week. Invitae will contribute longitudinal clinical data from its Ciitizen database, while Simons will provide its patient-reported outcomes and biospecimens. The partnership expands a previously launched pilot project for STXBP1 patients and the STXBP1 Foundation.
Strata Oncology this week announced that it has expanded a collaboration with Pfizer for its Strata PATH trial, a prospective pan-tumor study looking into the efficacy and safety of FDA-approved cancer therapeutics for new, biomarker-defined patient populations. As part of the expanded partnership, Pfizer will provide its drugs Braftovi (encorafenib), Mektovi (binimetinib), and Lorbrena (lorlatinib) for six new cohorts enrolling patients with early-stage lung cancer, colorectal cancer, melanoma, and other cancers that have remaining micrometastatic disease following initial treatment. Pfizer has already been supplying Braftovi, Mektovi, Lorbrena, Talzenna (talazoparib), and Inlyta (axitinib) for PATH trial cohorts enrolling patients with late-stage cancers. Many of the patients enrolled in the new cohort with micrometastatic disease will be tested through Strata's Sentinel trial, a 100,000-patient study of Strata's circulating tumor DNA minimal residual disease test.
OraSure Technologies said this week that its Diversigen subsidiary is collaborating with Mars Petcare on the Mars Petcare Biobank project. Specifically, Diversigen will sequence the microbiome of samples from cats and dogs of all breeds and breed mixes. Mars Petcare will then study the composition of cat and dog microbiomes in health and disease, as well as over time, with the goal of improving pet care.
Danaher said this week that its board of directors has approved a quarterly cash dividend of $.25 per share of its common stock, payable on Oct. 28 to shareholders of record on Sept. 30. The board also approved a quarterly cash dividend of $12.50 per share of its 5.00 Percent Series B Mandatory Convertible Preferred Stock, payable on Oct. 15 to shareholders of record on Sept. 30.
Also this week, Danaher provided updated guidance on its Q3 earnings results. The firm said it is expecting high single-digit base business core revenue growth, consistent with its original guidance. However, it noted that respiratory testing from its subsidiary Cepheid was ahead of expectations, with a forecast of more than $500 million in revenues in Q3, compared to guidance of about $325 million.
The company also announced that it would be separating its environmental and applied solutions business into an independent, publicly traded company. On a conference call to discuss the separation and the company’s bioprocessing business, Danaher CEO Rainer Blair said that the firm’s two bioprocessing subsidiaries, Cytiva and Pall, would form a biotechnology group within Danaher.
Zetta Genomics said this week that it has moved into a 1,038-square-foot office in Cambridge, UK, the company's first permanent location since it was spun out of the University of Cambridge in 2017. The new space will house the firm's business support, commercial, product, bioinformatics, and quality departments, as well as its executive team.
Premier Medical Laboratory Services said this week that it has gained a New York State Clinical Laboratory Permit. The lab, which processes up to 100,000 tests daily, already had Clinical Laboratory Improvement Amendments and College of American Pathologists certifications. Each state requires a clinical license from its public health department, and New York is among the few that require on-site inspections. The laboratory also passed New York's required proficiency testing.
LGC said this week it has opened a 36,000-square-foot facility at the Oxford Technology Park that will be the new home for The Native Antigen Company, part of LGC Clinical Diagnostics. The facility will also be the host site of an advanced workflow applications lab for LGC Biosearch Technologies. The site offers TNAC expanded manufacturing capacity to produce infectious disease reagents, antibodies, and assays. Meanwhile, the LGC Biosearch Technologies advanced workflow applications lab will support customers to adopt and optimize the use of LGC products.
CorDx said recently that it received EN ISO 13485 certification for the quality management systems of two facilities in San Diego and a third facility in Atlanta. The certification, provided by TÜV Rheinland, demonstrates the business conforms to quality process standards and ensures the safety and efficiency of the company's products, services, and systems, CorDx said.
Abbott this week declared a quarterly common dividend of $.47 per share, payable on Nov. 15 to shareholders of record at the close of business on Oct. 14.
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.