COMPANY:

Tempus

"This study aimed to predict patient outcomes to immune checkpoint inhibitors (ICI) by developing an integrated DNA/RNA ICI biomarker. A de-identified pan-cancer cohort from the Tempus multimodal real-world database was utilized to develop and validate the Immune Profile Score (IPS) algorithm that leverages Tempus xT (DNA sequencing) and xR (RNA sequencing). The researchers found that IPS status can be used to stratify patient cohorts and prognosticate ICI-treatment response....The team analyzed real-world imaging patterns from a cohort of 4,147 advanced cancer patients treated with immune checkpoint inhibitors (ICI) across five solid tumor types....Incorporating these patterns into a microsimulation model, the team demonstrated that using the molecular biomarker in conjunction with CT imaging provided substantial cost savings and reduced inappropriate therapy compared to imaging alone, with the most benefit observed in small cell lung cancer (SCLC) treated with ICI-chemotherapy."

"Tempus AI...announced the clinical launch of its Immune Profile Score (IPS) algorithmic test. IPS, which is now available for clinicians to order, is a multimodal biomarker that can be used as a prognostic indicator for adult patients with stage IV and metastatic pan-solid tumors who are already considered candidates for immune checkpoint inhibitor (ICI)-based therapy. Tempus is presenting the results of its validation study at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting, which demonstrated that IPS-High patients in the study were more likely to have an overall survival benefit while receiving ICI-based therapy than IPS-Low patients in the study (HR 0.45). Tempus validated IPS in a retrospective study involving 1,600 metastatic and/or stage IV adult patients with 19 different solid tumor types from the company’s real-world de-identified database."

Tempus...today announced a collaboration with JW Pharmaceutical...to leverage both real-world data (RWD) and biological modeling to support efficient hypothesis generation and rapid validation in early therapeutic research in oncology. JW Pharma is an early adopter of integrating RWD into drug research and development programs, and it is now tapping into Tempus’ rich multimodal dataset and extensive repository of organoid models to accelerate its efforts in multiple indications."

"Tempus AI...today announced a multi-year collaboration with BioNTech SE... This collaboration leverages Tempus’ robust multimodal datasets in support of BioNTech’s next-generation oncolo- gy pipeline."

"BerGenBio ASA...announced today a collaboration with Tempus...to advance the clinical development of BerGenBio's selective AXL inhibitor bemcentinib in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients with STK11 mutations (STK11m). BerGenBio's on-going BGBC016 Phase 1b/2a trial is designed to assess the benefit of adding bemcentinib to the current standard of care treatment (immunotherapy + doublet chemotherapy) in 1L STK11m patients, a population with poor outcomes and no specific therapies today.....Upon conclusion of the BGBC016 study, the parties intend to present insights derived from the resulting data to appropriate regulatory agencies as a next step in the further development of bemcentinib."

"Personalis and Tempus AI...they are expanding their commercial relationship, with Tempus investing approximately $36 million into Personalis and accelerating its commercialization efforts for Personalis' minimal residual disease test."

P=Obs | N=200 | BASECAMP-1 (NCT04981119) | Sponsor: A2 Biotherapeutics Inc. | "Tempus AI...announced that the validation study of its human leukocyte antigen (HLA) loss of heterozygosity (LOH) investigational assay has been published in npj Precision Oncology...the study included analytical validation of an investigational test that detects HLA-LOH based on analysis of data generated from Tempus’ FDA-approved, next generation sequencing-based xT CDx assay...The study evaluated the test’s ability to accurately detect HLA-LOH in clinical samples with >=40% tumor cells. In collaboration with A2 Biotherapeutics, Tempus analyzed data from an observational clinical trial (NCT04981119), and demonstrated the feasibility of identifying HLA-LOH patients and accruing them into prospective studies by leveraging analysis of routinely obtained clinical diagnostic data. Results support the assay's use as an investigational device for precision oncology clinical trial use."

"Tempus AI, Inc...today announced the launch of a new program specifically geared towards using algorithms to surface patients who are more likely to test positive for actionable biomarkers, and who should receive confirmatory testing in accordance with clinical guidelines. This program is part of the larger Tempus Next platform, which is designed to identify care gaps and equip clinicians with actionable insights at the point of care. The new Next program is now available and initially focused on the identification of care gaps associated with the human epidermal growth factor receptor 2 (HER2) testing recommended under clinical guidelines for patients with select metastatic cancers....As part of the initial launch, Tempus has built an algorithm that runs as part of xR, the company’s RNA sequencing assay, to help surface patients who are particularly likely to benefit from on-guideline immunohistochemistry (IHC) testing."

"Tempus AI, Inc...announced an expanded collaboration with Remix Therapeutics, a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease. The collaboration between Remix and Tempus began with the licensing of specific, de-identified data cohorts and has since expanded into a broader, strategic alliance. Remix is leveraging Tempus’ multimodal data to interrogate specific cohorts, including Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) with Tempus’ data analytics platform, Lens. The newly expanded scope of work also includes next-generation sequencing support for Remix’s Phase I trial for REM-422, the company’s potent, selective, oral small molecule messenger RNA (mRNA) degrader."

"Tempus AI...has reached a research milestone of over 500 research publications. In the last eight years, Tempus has invested in rigorous scientific research to validate its diagnostic offerings, while also working with biopharma and academic collaborators to publish research supported by the company’s multimodal data library."

"Tempus AI...announced that the company’s PurISTSM algorithmic test has received a proprietary laboratory analysis (PLA) code from the American Medical Association (AMA)."

"Tempus AI, Inc...today announced that the Centers for Medicare & Medicaid Services (CMS) has granted Advanced Diagnostic Laboratory Test (ADLT) status for Tempus’ next-generation sequencing assay, xT CDx. xT....This CMS determination affirms that Tempus’ xT CDx meets the rigorous criteria for new ADLT status, which is reserved for novel products that provide new clinical diagnostic information that cannot be obtained any other way, or products cleared or approved by the FDA. The initial ADLT rate established by CMS is $4,500. During the nine-month period beginning July 1, 2024 and ending March 31, 2025, Tempus shall be reimbursed the established ADLT rate while it collects and submits to CMS the private payor payment amounts for xT CDx. Beginning April 1, 2025, CMS will establish a new Medicare rate based on the weighted median of private payer amounts."

"Guardant Health filed a lawsuit...against rival cancer genomics firm Tempus AI, alleging that Tempus has infringed a handful of its patents relating to liquid biopsy sequencing methods...Guardant specifically cited Tempus' Tempus xF, Tempus xF+, and Tempus xM Monitor assays as examples, as well as the firm's recently developed minimal residual disease offering, Tempus xM MRD."

"Tempus...announced new testing solutions to help physicians identify patients with HER2 or FOLR1 expressing tumors, which may make such patients eligible for targeted therapies such as antibody–drug conjugates (ADCs). HER2 and FOLR1 testing by immunohistochemistry (IHC) is now available for all solid tumor cancers as an add-on to the company’s xT or xR next-generation sequencing assays....Tempus is now offering these two IHC tests, which are recommended in clinical guidelines for several cancer types and may be ordered for other cancer types at the clinician's discretion. The new offerings further expand Tempus’ comprehensive portfolio of testing solutions that is designed to help physicians maximize and optimize treatment options for each of their patients."

"Tempus...announced the company is scheduled to exhibit 16 abstracts at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, which convenes from May 31-June 4 in Chicago, Illinois. This year, Tempus is presenting its latest research, including new data from its minimal residual disease (MRD) assay, xM."

"Tempus...today announces an expansion of its collaboration with AstraZeneca, which leverages Tempus Next to arm physicians with technology that supports the delivery of guideline-directed biomarker testing for patients with non-small cell lung cancer (NSCLC). The magnitude and frequency of updates to oncology guidelines each year make it difficult for the updates to be rapidly incorporated into patient treatment plans. As part of a larger, strategic collaboration, the two companies are now expanding upon a pilot program that utilizes Next, Tempus’ care pathway intelligence platform, to help physicians determine if their patients with NSCLC may benefit from guideline-directed molecular testing, including testing for epidermal growth factor receptor (EGFR) mutations."

"Tempus...is introducing Tempus Next, a care pathway intelligence platform. By harnessing the power of AI, Tempus Next identifies care gaps and equips clinicians with actionable insights at the point of care, supporting access to the most up-to-date, guideline-directed treatments."

"Tempus...announces the clinical launch of p-MSI, a digital pathology algorithm using H&E whole slide images that is available with the company’s xT assay for patients with prostate cancer. This offering aims to identify patients who may be more likely than the average patient with prostate cancer to have a tumor that is microsatellite instability high (MSI-H), and therefore potentially eligible for immunotherapy."

"Tempus...announced a generous data contribution of de-identified tumor profiles with limited associated clinical information from more than 3,000 cancer diagnoses to the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). This is a first of its kind contribution to NCI’s planned Data Enclave and will support the NCI’s mission of advancing cancer research by learning from each individual with cancer."

"Ambry Genetics...and Tempus...announced today that they have entered into a strategic collaboration to offer best-in-class, comprehensive, germline and somatic testing services...As part of the agreement, Ambry is performing germline sequencing assays for Tempus, powered by Ambry’s CancerNext®️ and CancerNext-Expanded®️ assays...Tempus’ xG and xG+ germline assays are a part of Tempus' extensive portfolio of oncology-focused testing solutions that maximize biomarker detection and identify actionable variants linked to targeted therapy and clinical trial options."

"Tempus...announced that the company has signed an agreement for in-network provider status with Cigna Healthcare. The collaboration signifies an important stride in enhancing accessibility to Tempus’ array of molecular profiling tests for Cigna’s extensive network, which comprises approximately 16 million members."

"Tempus...announced that the company has signed agreements for in-network provider status with Humana Inc. Under the agreement, Humana’s over 13 million members will have improved access to Tempus’ portfolio of molecular profiling tests in accordance with their medical policies, expanding precision oncology care throughout the country."

"Tempus...today announced the addition of a novel MRD assay, xM, to its comprehensive testing solutions. The tumor-naïve plasma based test is available for research use only to detect circulating tumor DNA (ctDNA) in the blood of patients with early stage CRC after surgery...xM is a liquid biopsy approach to MRD assessment, where no baseline tumor tissue is required...At the 2024 ASCO^® Gastrointestinal Cancers Symposium, Tempus is presenting research that demonstrates xM’s ability to detect clinical recurrence of early stage CRC with high clinical specificity (94%) and sensitivity (53%) at a landmark single time point 4 weeks after curative surgery. In addition to the data being presented, Tempus is still running further clinical validation studies, through which it expects these numbers could improve over time."

"Tempus...announced its participation in the National Cancer Institute’s (NCI) ComboMATCH group of precision medicine trials. The ComboMATCH trials aim to pair patients with a therapy that has the potential to manage their tumor and help assist physicians in devising more effective treatment strategies for individuals with locally advanced or advanced solid tumors. Tempus is one of the NCI-designated commercial laboratories for the initiative...Oncologists at participating ComboMATCH clinical sites can leverage their patients’ results from Tempus’ signature xT assay to determine their potential suitability for the program’s treatment trials."

"SkylineDx...is announcing a strategic commercial collaboration with Tempus, a leader in precision medicine. This collaboration aims to advance patient care by expanding the accessibility to the SkylineDx Merlin™ Test, further solidifying both companies' commitment to improving patient outcomes...The Merlin™ Test is a molecular diagnostic tool developed by SkylineDx, designed to provide personalized insights into early-stage melanoma cancer patients' treatment options....This collaboration marks a significant milestone in the journey to advance precision medicine and personalized healthcare. By combining the strengths of SkylineDx and Tempus, the collaboration is poised to further improve accessibility for patients to the latest medical innovations."

"Personalis, Inc...and Tempus Labs, Inc...announced a strategic collaboration to co-commercialize NeXT Personal® Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer. NeXT Personal Dx is a leap forward in tumor-informed approaches, setting the new standard in performance of MRD tests with unprecedented sensitivity and high specificity. The test was launched by Personalis in October of this year."

"Tempus...announced that City of Hope Comprehensive Cancer Center has joined Tempus+, a proprietary program that powers collaborative precision oncology research through the use of real-world data. The Tempus+ community of researchers represents over 30 medical centers that are leveraging the program to advance its research."

"Tempus...announced that Palmetto GBA, a Medicare Administrative Contractor, and the Molecular Diagnostics Services Program (MolDx) has approved coverage for Tempus|xT, Tempus’ 648-gene DNA sequencing panel, for use in solid tumor and hematologic malignancies, performed in Tempus’ CAP/CLIA laboratory located in Research Triangle Park in North Carolina."

"Tempus...announced a multi-year, strategic collaboration with Recursion...The two companies are working together to advance biomarker-driven therapeutic development with a data-first approach...Through this collaboration, Recursion has access to Tempus’ library of de-identified, multimodal data to derive insights that have the potential to further Recursion’s therapeutic development."

"Tempus...announced a multi-year, strategic research collaboration with Bristol Myers Squibb...The two companies will work together to identify new targets and validate them faster and with higher confidence using multimodal datasets, computational approaches, and patient-derived disease models in specific cancer disease areas."

"Tempus...announced xF Monitor – a new circulating tumor DNA (ctDNA) assay for research use only, which detects and monitors changes in circulating tumor fraction to determine early response to immunotherapy for patients with advanced cancers."

"Tempus...announced eight abstracts were accepted for presentation at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting, which convenes in San Diego, California, from November 1-5, 2023."

"Tempus...announced five abstracts were accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2023, which convenes in Madrid, Spain, from October 20-24, 2023."

"Tempus...announced that the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center has joined Tempus+, a proprietary program that powers collaborative precision oncology research through the use of real-world data. The Tempus+ community of researchers already includes over 30 medical centers that are leveraging the program to advance its research."

"CureMD...said Tuesday that it has formed a partnership with Tempus to integrate genomic test workflows into its electronic health records system."

"Tempus...announced that the U.S. Food & Drug Administration (FDA) has granted the company Breakthrough Device Designation for its HLA-LOH assay as a companion diagnostic (CDx) test. The test uses a machine learning model to analyze sequence data produced by Tempus’ FDA-approved, next generation sequencing-based xT CDx assay. It is intended to identify cancer patients with solid tumors who may benefit from treatment with specific targeted therapies when a patient’s tumor has experienced allele-specific loss of heterozygosity (LOH) for specific human leukocyte antigen (HLA) Class I alleles."

"Tempus...announces its GEMINI Non-small Cell Lung Cancer (NSCLC) study (NCT05236114). The Tempus-sponsored study, being run in collaboration with AstraZeneca, aims to create a robust multi-omic dataset for patients with NSCLC to facilitate future novel research related to precision medicine, diagnostic development, and biomarker discovery....Patients enrolled in the trial will be studied for up to three years to assess the impact of their underlying tumor biology on disease progression and therapy efficacy. The results of this study will be used for biomarker discovery, including potential use of circulating tumor DNA (ctDNA) testing to measure MRD."

"Tempus...today announced a new collaboration to develop a companion diagnostic (CDx) test with TScan Therapeutics...for the treatment of cancer patients. The collaboration supports TScan’s screening protocol for its Phase 1 solid tumor clinical trial which is designed to enable customized mixtures of TCR-Ts to be administered to patients based on tumor antigen positivity and intact HLA expression...TScan is collaborating with Tempus to use the xT assay, Tempus’ 648-gene panel, to prospectively identify patients with HLA loss in the tumor to select TCR-Ts that recognize HLA genes still intact in the patient’s tumor."

"Tempus...introduces its standalone RNA next-generation sequencing assay, Tempus xR. xR is a whole transcriptome panel for solid tumors, reporting clinically relevant fusions for more than 100 targeted genes, as well as altered splicing for MET Exon 14 and EGFRvIII."

"Tempus...announced the company will exhibit 20 abstracts at the 2023 American Society of Clinical Oncology (ASCO®) Annual Meeting, which convenes from June 2-6, in Chicago, Illinois. This year, Tempus is presenting its latest research via two oral presentations, one poster discussion session, and several poster presentations."

"GeneCentric Therapeutics...announced today that its PurIST^SM test is now commercially available through Tempus for clinical use. PurIST is a novel RNA-expression test that identifies patients with the classical subtype of pancreatic ductal adenocarcinoma (PDAC) who are likely to experience longer overall survival (OS) with standard-of-care (SOC) FOLFIRINOX than patients with the basal subtype of PDAC."

"Tempus...announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first Premarket Approval (PMA) application for its companion diagnostic test, xT CDx. xT CDx is a 648-gene next-generation sequencing test for solid tumor profiling, which includes microsatellite instability status and companion diagnostic claims for colorectal cancer patients."