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In Brief This Week: Quest Diagnostics, LabCorp, PerkinElmer, Thermo Fisher Scientific, and More

NEW YORK – Ahead of its virtual investor day this week, Quest Diagnostics said that it plans to buy back $900 million worth of its common stock during the first half of 2021. Additionally, it maintained its top- and bottom-line guidance for the first six months of the year. Net revenues are expected to be in the range of $4.85 billion to $5.15 billion, which would represent year-over-year growth of 33 percent to 41 percent. Reported EPS is expected to be in the range of $5.07 to $6.07, while adjusted EPS is anticipated to be between $5.90 and $6.90. The Secaucus, New Jersey-based firm added that it expects COVID-19 testing to continue into 2022 at lower levels as its transitions from testing for clinical uses to support for so-called "return to life" activities.

PathAI and Laboratory Corporation of America this week announced they have broadened an existing partnership to include the potential development of companion diagnostics using PathAI's algorithms. The extended collaboration builds on a prior investment by LabCorp into Boston-based PathAI, which develops artificial intelligence-based technology for pathology applications. A key focus of the collaboration will be the use of the algorithms in programs managed by LabCorp Drug Development in prospective clinical trials of cancer and other diseases, and specifically their use in the development of companion diagnostics. According to PathAI, the algorithm can be used in retrospective and prospective clinical trials, in both the quantification of tissue-based biomarkers and patient stratification and selection. The partners will also evaluate the potential use of AI-powered algorithms in a clinical laboratory setting. Financial and other terms were not disclosed.

PerkinElmer said this week that it has completed the acquisition of Oxford Immunotec for $591 million. At the time the deal was announced, PerkinElmer said the acquisition would enable it to grow its infectious disease testing portfolio to include tuberculosis detection.

Separately, in a document filed with the US Securities and Exchange Commission this week, the company said that it issued $400 million aggregate principal of 2.55 percent senior notes due 2031 and $400 million aggregate principal amount of 3.625 percent senior notes due 2051. PerkinElmer said it expects net proceeds from the offering, which was announced last week, to be $793.8 million. PerkinElmer plans to use about $561 million of the net proceeds to repay debt under its senior unsecured revolving credit facility to fund part of its acquisition of Oxford Immunotec. It plans to use the remaining proceeds to repay at maturity a portion of its outstanding €300 million ($359 million) aggregate principal amount of .600 percent senior notes due 2021.

Thermo Fisher Scientific said this week that it has recently completed the repurchase of an additional $500 million in shares of its common stock, which have a face value of $1 per share, pursuant to the firm's current authorization. The company had previously repurchased $1.5 billion worth of shares in January.

OpGen announced in a filing with the US Securities and Exchange Commission this week that it entered into a warrant exercise agreement with an institutional investor. In November, the company entered a securities purchase agreement with the option to exercise warrants to purchase 4,842,615 shares of common stock six months after their issuance at $1.94 per share.

In exchange for exercising all of the warrants, OpGen issued new warrants to purchase 0.65 shares of common stock for each share of common stock issued when the old warrants were exercised. The new warrants will have an exercise price of $3.56, are immediately exercisable, and expire in five years. The investor will pay $314,770 for the new warrants, and OpGen expects to receive gross proceeds of $9.7 million from the exercise of the existing warrants and purchase of new warrants.

Natera said this week that the first patient has been screened for the IMvigor011 Phase III clinical trial the firm is conducting in partnership with Genentech. The trial is using Natera's Signatera molecular residual disease (MRD) test as a companion diagnostic to identify muscle-invasive urothelial carcinoma patients eligible for investigational treatment with Genentech's cancer immunotherapy drug atezolizumab (Tecentriq). Results from an earlier trial, IMvigor010, had shown that 37 percent of patients who tested MRD-positive with Signatera after surgery experienced significant benefit from the drug.

Allegheny Health Network Cancer Institute opened a clinical genomics laboratory this week that offers comprehensive, in-house genomic testing for cancer patients. The lab will provide next-generation sequencing of blood or tumor samples for patients with metastatic and some early-stage tumors, including breast, colon, and lung cancer. The lab will use Allegheny Health Network's in-house NGS panel, which interrogates 523 genes, including structural rearrangements and tumor mutation burden. The lab is also developing a blood-based assay to monitor treatment response and disease recurrence. The latest offering is part of a precision oncology partnership between Allegheny Health Network and health insurer Highmark Health that also includes a translational research lab and genomics repository.

GlycoPath, a Charleston, South Carolina-based developer of bioanalytical assays based on immunoaffinity technology, said this week that it has closed a seed financing round with new minority investor Bruker for an undisclosed amount. GlycoPath's research-use-only GlycoTyper technology captures diagnostic glycoproteins from blood using multiplexed slide arrays, followed by direct analysis of the glycans present on each glycoprotein using MALDI-TOF mass spectrometry. GlycoPath said its initial pathology target for the technology is hepatic fibrosis, for which the firm hopes to create a laboratory-developed test for initial patient screening and surveillance of at-risk populations.

Yourgene said this week that it has signed a contract with Cytox to run that company's GenoScore-Lab genetic test for the prediction of Alzheimer's disease risk in its Citylabs 1.0 laboratory in Manchester. The two companies signed a collaboration agreement last October and have concluded beta-testing for the array-based test, which calculates a polygenic risk score and was CE-marked last month.

NEC Corporation said this week that it has joined the Norwegian Precision Cancer Medicine Implementation Consortium (CONNECT), a public-private collaboration between 22 partners with the goal of advancing precision cancer medicine. CONNECT fosters collaboration in diagnostics, clinical trials, implementation of advanced precision medicine, and the use of health data, including for health economics analysis. In joining the Norwegian consortium, NEC — which has developed an artificial intelligence-based neoantigen prediction system — hopes to tap into real-world data to accelerate its immunotherapy activities. 

Mountain View, California-based Specific Diagnostics this week announced the formation of Specific Diagnostics UK, its third European subsidiary. The company began its European operations in France with seven evaluation sites. Specific Dx also has commercial operations in Germany and the Middle East.

Inivata said this week that the US Food and Drug Administration has granted Breakthrough Device Designation to its RaDaR liquid biopsy assay. The next-generation sequencing assay tracks up to 48 tumor-specific variants to detect residual disease following initial cancer treatment. 

Caris Life Sciences said this week that Curie Oncology has joined Caris’ Precision Oncology Alliance. The alliance is a collaborative network of cancer centers that work together with the goal of advancing comprehensive cancer profiling and establishing standards of care for molecular testing in oncology through research focused on predictive and prognostic markers that improve clinical outcomes of cancer patients. The Caris Precision Oncology Alliance now includes 49 cancer centers and academic institutions that have early access to Caris’ database and artificial intelligence platform, as well as the Caris CODEai data solution, which contains cancer treatment information and clinical outcomes data for more than 244,000 patients.

Curie Oncology is a boutique oncology practice in Singapore that provides multidisciplinary cancer care. It specializes in complex oncology that is guided by precision diagnostics to find cancer biomarkers that can improve therapy options and outcomes.

Becton Dickinson announced this week it has collaborated with medical software developer ImageMover to create a companion mobile app for its BD Veritor Plus System. The app, which is available immediately, is expected to streamline reporting of SARS-CoV-2 antigen test results in point-of-care setting that lack healthcare IT infrastructure. For traditional acute care settings, BD continues to offer its Synapsys Informatics solution for automated result reporting, streamlined CARES Act and other Health and Human Services-mandated reporting, and analytics and report creating. BD said that the ImageMover collaboration is separate from an ongoing collaboration with Scanwell Health on a lateral flow antigen test paired with a mobile app for at-home use.

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.