On January 24, 2024 Abbott reported financial results for the fourth quarter ended Dec. 31, 2023 (Press release, Abbott, JAN 24, 2024, View Source [SID1234639447]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Fourth-quarter sales increased 1.5 percent on a reported basis, 2.1 percent on an organic basis, and 11.0 percent on an organic basis, excluding COVID-19 testing-related sales1.
Fourth-quarter GAAP diluted EPS of $0.91 and adjusted diluted EPS of $1.19, which excludes specified items.
Abbott issues full-year 2024 guidance for diluted EPS on a GAAP basis of $3.20 to $3.40 and full-year adjusted diluted EPS of $4.50 to $4.70.
Abbott projects full-year 2024 organic sales growth, excluding COVID-19 testing-related sales, to be in the range of 8.0% to 10.0%2.
In 2023, Abbott continued to recapture market share in the U.S. infant formula market. The company has now reclaimed its previous market-leading position, as measured on a volume basis.
In December, Abbott announced U.S. Food and Drug Administration (FDA) approval of its new laboratory automation system, GLP systems Track, to help laboratories optimize performance and safety to better meet the growing demand for diagnostic testing.
In January, Abbott announced that the first-in-human procedures were conducted using the company’s new Volt Pulsed Field Ablation (PFA) System to treat patients with heart rhythm disorders such as atrial fibrillation (AFib). These procedures were part of Abbott’s Volt CE Mark clinical study. Abbott anticipates approval for its U.S. clinical trial (IDE) for the Volt PFA System in the first half of 2024.
In January, Abbott announced that Tandem Diabetes Care’s t:slim X23 insulin pump is the first automated insulin delivery system in the U.S. to integrate with Abbott’s new FreeStyle Libre 2 Plus sensor.
"The strength and diversity of the Abbott portfolio drove our success in 2023," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re entering 2024 with a lot of positive momentum, and with our highly productive pipeline, we’re well-positioned for growth in 2024 and beyond."

FOURTH-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of exiting the pediatric nutrition business in China, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI), is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

On January 23, 2024 Johnson & Johnson reported fourth quarter and Full-Year 2023 Results (Press release, Johnson & Johnson, JAN 23, 2024, View Source [SID1234639453]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On January 23, 2024 Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, reported the initiation of its clinical study evaluating the diagnostic performance of miLungDx, a blood-based small RNA panel engineered to detect non-small cell lung cancer (NSCLC) (Press release, Hummingbird Diagnostics, JAN 23, 2024, View Source [SID1234639445]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The primary endpoint of the prospective, longitudinal, observational study (NCT05987189) is to detect the absence or presence of lung cancer, as determined by all follow-up imaging and pathological data obtained throughout the duration of the study. Based in the United States, the study will include 2,000 patients with the expected patient enrollment to be completed within 12 months after study initiation.

"The initiation of patient recruitment for this clinical study marks an exciting milestone for the team at Hummingbird Diagnostics and underscores our mission to improve human health through the development of novel small RNA blood tests," remarked Bruno Steinkraus, PhD, Chief Scientific Advisor of Hummingbird Diagnostics. "We believe miLungDx has the best performance reported from a blood test for early-stage lung cancer to date. We look forward to the continued development of this RNA panel."

Hummingbird Diagnostics has reported best in class performance for early detection of lung cancer published in the Journal of Thoracic Oncology and presented at ASCO (Free ASCO Whitepaper) 2023.

On January 23, 2024 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on the need for noninvasive, accurate tests for the detection of early-stage cancer and lung disease, reported that India’s Office of the Controller General of Patents, Designs and Trade Marks has issued a Certificate of Grant of Patent to bioAffinity subsidiary OncoSelect Therapeutics, LLC for its compositions and methods to treat cancer using chemotherapeutic agents conjugated to porphyrins, resulting in targeted delivery of the drugs (Press release, BioAffinity Technologies, JAN 23, 2024, View Source [SID1234639444]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Indian patent, titled "Porphyrin Compounds and Compositions Useful for Treating Cancer" is an important addition to bioAffinity Technologies’ patent portfolio, which includes 16 awarded U.S. and foreign patents and 23 pending patent applications related to its porphyrin-based diagnostic platform and cancer treatment therapeutics.

"India’s patent is an acknowledgement of the value of our ongoing research, development and commercialization of porphyrin-based diagnostics and targeted treatments for lung cancer and other diseases," bioAffinity Technologies’ President and CEO Maria Zannes said. "We are committed to improving the outcome for cancer patients around the world, beginning with lung cancer, the deadliest cancer killer. Strong intellectual property protection for our innovative science benefits not only patients in need of treatment and their physicians, but also our research team and our shareholders as well."

bioAffinity Technologies’ first product, CyPath Lung, is a porphyrin-based diagnostic test for early-stage lung cancer. Physicians use CyPath Lung for patients at high risk for developing lung cancer, often after recommended screening reveals indeterminate pulmonary lung nodules that may or may not be malignant. CyPath Lung is a noninvasive test that uses advanced flow cytometry and artificial intelligence to differentiate patients with cancer from those who do not have the disease.

On January 23, 2024 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported a master agreement with Duke University School of Medicine, one of the nation’s leading institutions for healthcare education, clinical healthcare provision, biomedical research, and community engagement, to collaborate on multiple research projects across lung cancer, gastrointestinal, genitourinary and skin cancers (Press release, BostonGene, JAN 23, 2024, View Source [SID1234639443]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The strategic partnership allows Duke physicians and researchers to leverage BostonGene’s expertise to drive the molecular and cellular characterization of the patient’s tumor, microenvironment and immune system and test its predictive value in response to treatment. For cancer patients undergoing treatment at Duke University, including those participating in clinical trials, BostonGene will provide state-of-the-art analytics, interpretation and visualization of big data obtained from analysis of patients’ genomic, transcriptomic, cell phenotyping, proteomic and imaging studies.

"Our collaboration with BostonGene is a testament to our commitment to excellence in healthcare and research. This study will enable us to explore the boundaries of predictive biomarkers and potentially offer new treatment options to patients," said Jeffrey Clarke, MD, Associate Professor of Medicine at Duke University School of Medicine.

"The partnership with Duke University signifies a pivotal step in actualizing AI-driven molecular insights to transform patient care," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our combined expertise will study the complex genetic landscape of a patient’s tumor, microenvironment and immune system, paving the path towards personalized treatments for all patients."

In its flagship study, led by Dr. Clarke at Duke and BostonGene molecular profiling and comprehensive analyses will be conducted on a meticulously annotated real-world cohort of non-small cell lung cancer (NSCLC) patients who received treatment with either checkpoint inhibitors alone or in conjunction with chemotherapy. The study’s primary objective is to assess predictive biomarkers that can more accurately pinpoint the subset of patients poised to derive maximum benefits from immunotherapy in the context of metastatic NSCLC.