Diagnostics & Genomics

Note on naming: this is Artera of Los Altos, California (artera.ai), developer of multimodal AI cancer tests. It is unrelated to the separately indexed Artera of Santa Barbara (artera.io), which makes patient communication agents. The two companies share a name and nothing else. The ArteraAI Prostate Test is a multimodal artificial intelligence model combining digitized histopathology images from an existing biopsy with structured clinical data including age, PSA, and tumor stage, producing a continuous risk score from 0 to 1 with pre established cut points corresponding to roughly 3 percent and 10 percent estimated ten year risk of distant metastasis. It requires no additional procedure because it reads tissue already taken. Beyond prognosis it is predictive: for NCCN intermediate risk patients it estimates whether adding short term androgen deprivation therapy to radiation will reduce risk, which the literature describes as the first predictive biomarker for that decision. The algorithm is pre established and locked at version 1.2, developed from large datasets and multiple phase 3 randomized trials with up to 15 years of follow up. Regulatory and guideline standing is unusually complete: FDA De Novo marketing authorization in August 2025, inclusion in the NCCN Clinical Practice Guidelines for Prostate Cancer as the first and only AI risk stratification tool, and CMS coverage with a payment rate effective January 2024. In June 2026 the company introduced a digital pathology based test providing individual risk estimates in metastatic hormone sensitive prostate cancer. Co-founded by Felix Y. Feng of UCSF; CEO Andre Esteva.

AI digital pathology platform spanning human, veterinary, and environmental laboratories, developing in this field since 2013. Techcyte Fusion is positioned as the first digital workflow integrating anatomic and clinical pathology in one platform, with deep learning models identifying parasitic cells, bacteria, and cancer cells, plus digitization enabling remote case review. Product areas include parasitology, bacteriology, hematology with a peripheral blood smear classifier, cervical cytology, and bladder cancer surveillance. Regulatory status is the decisive buyer fact and the company states it plainly: the anatomic and clinical pathology platform and its human products are Research Use Only in the United States, while Fusion carries CE-IVDD marking in Europe. The architecture is deliberately open rather than proprietary, connecting to numerous slide scanners, laboratory information systems, and third party AI developers through a Fusion Partner Program; one such partner, Modella AI, brought its PathChat research copilot to the platform and was subsequently acquired by AstraZeneca in January 2026. A long running Mayo Clinic collaboration provides access to the Safe Harbour dataset of more than 17 million de-identified slides and pathology reports for model development. The company reports its veterinary segment is already profitable, with human and environmental segments targeted for profitability by 2027, and raised $15 million to expand the platform. Headquartered in Orem, Utah; CEO Ben Cahoon.

Indexed for what is commercially available today, which requires care because the company's own AI algorithms are not yet cleared. MyoVista Insights is a cloud based ECG reporting and management platform, in phased rollout since May 2025 and shipping at version 1.3 as of June 2026, positioned to replace on premise ECG management software. Its AI-ECG Algorithm Marketplace, introduced in version 1.3, integrates third party algorithm results into the platform, and the first algorithm made available is Bunkerhill Health's FDA cleared ECG-EF model detecting reduced left ventricular ejection fraction at or below 40 percent from a routine 12-lead ECG. Bunkerhill is separately indexed here, so this is a distribution relationship between two vendors in this index rather than a HeartSciences algorithm. The company's own pipeline is not yet available: the MyoVista wavECG device, a 12-lead resting ECG built to host AI-ECG algorithms, was submitted for 510(k) clearance in December 2025 and clearance was not confirmed at the time of this record; its impaired cardiac relaxation algorithm was deliberately separated from that submission to complete additional validation against revised American Society of Echocardiography guidelines for diastolic dysfunction; and its low ejection fraction algorithm remains in pre submission work. Underlying intellectual property is licensed in part from the Icahn School of Medicine at Mount Sinai. Assistive AI-ECG assessments are eligible for Medicare reimbursement under the Hospital Outpatient Prospective Payment System at APC 5734. NASDAQ: HSCS.

AI models of tumor and immune biology applied to precision oncology, serving both clinical care and drug development. The Tumor Portrait test integrates DNA and RNA exome sequencing into a single end to end assay, approved under CLIA, CAP, and the New York State Department of Health, producing tumor driver, microenvironment, and actionable biomarker characterization from one sample. Kassandra is the company's cell deconvolution model for reconstructing tumor microenvironment composition. Clinical and analytical validation was published in Communications Medicine, part of the Nature portfolio, across more than 2,200 tumors, reporting high reproducibility and clinical actionability in 98 percent of cases. Research collaborations span MD Anderson Cancer Center, Weill Cornell Medicine, and the Parker Institute for Cancer Immunotherapy, with nine abstracts accepted at ASCO 2026, and biopharma partnerships include Takeda for trial design and biomarker signature identification. A Japan joint venture operates with NEC Corporation and Japan Industrial Partners.

Rare disease genomic diagnosis (NASDAQ: WGS), applying AI and expert variant interpretation to exome and genome sequencing. GeneDx Infinity is the company's rare disease genomic dataset, accumulated over roughly 25 years and described by the company as the largest and most comprehensive of its kind. Products span ExomeDx and GenomeDx, both granted FDA Breakthrough Device designation, ultraRapid genome sequencing returning results for NICU and PICU patients in as little as 48 hours, and GenomeDx Prenatal, a phenotype informed trio based whole genome test for pregnancies with fetal anomalies. The company is the sole commercial testing provider for the NIH BEACONS genomic newborn screening initiative, which aims to enroll up to 30,000 newborns across as many as ten states. Reimbursement position is unusually well documented: Medicaid coverage for exome or genome sequencing in the pediatric outpatient setting across 38 states and for rapid genome sequencing in the NICU across 17. Full year 2025 revenue of $427.5 million with 2026 guidance of $475 to $490 million.

Precision oncology company (NASDAQ: CAI) combining comprehensive molecular profiling with AI interpretation. MI Cancer Seek received FDA approval in November 2024 and is, per the company, the first and only assay performing simultaneous whole exome and whole transcriptome sequencing with FDA approved companion diagnostic indications for solid tumors, analyzing more than 23,000 genes from a single tissue sample for adult and pediatric patients. The CodeAI platform runs over a large multimodal clinico genomic dataset to generate Caris AI Insights, a set of proprietary signatures predicting therapy response, tissue of origin, and metastasis risk, delivered in the Caris Molecular Tumor Board Report. Signatures added through 2026 include brain metastasis risk in breast and lung cancer, trained on 12,994 NSCLC and 3,371 breast cancer cases with matched survival outcomes. MI Clarity applies AI and computational pathology to stratify breast cancer recurrence risk without genomic sequencing. Caris Assure is the blood based platform. Went public in June 2025 raising $494 million; biopharma partners include a large alliance with Merck KGaA.

Enterprise genomics platform for health systems, payers, and life sciences. Health systems run population genomics programs on Helix infrastructure, covering recruitment, clinically actionable disease screening, return of results, and research, built on the proprietary Exome+ assay and a CLIA certified, CAP accredited sequencing lab. The Helix Research Network spans roughly 20 health system members and a reported 400,000+ sequenced participants, feeding GenoSphere, a linked clinico-genomic dataset that passed 500,000 records in June 2026, each combining Exome+ sequencing with an average of 13 years of EHR history and 8 years of claims. AI tooling is a recent layer rather than the foundation: an AI Cohort Builder launched June 2026 and a Model Context Protocol connector for querying the dataset launched July 2026. Health system programs include Cone Health, Sanford Health, WellSpan, St. Luke's University Health Network, HealthPartners, Nebraska Medicine, and Memorial Hermann.

Blood based early cancer detection built on a multiomics platform that analyzes genomic, epigenomic, and proteomic biomarkers and applies machine learning classifiers to detect cancer signals in circulating tumor DNA at single base methylation resolution. SimpleScreen CRC, the colorectal screening test, has a Premarket Approval application under FDA review submitted August 2025, with the company anticipating a decision in 2026; it is not FDA approved. The pivotal PREEMPT CRC validation study was published in JAMA in 2025, and blood based testing was included in the American Cancer Society's updated colorectal screening guideline in 2026. An updated assay version reported 85 percent sensitivity for colorectal cancer and 22 percent for advanced precancerous lesions at 90 percent specificity in a 966 sample head to head validation. Under an exclusive license agreement, Exact Sciences holds US commercial rights, and a separate commercial collaboration with Abbott covers bringing the test to market.

Lung cancer diagnostics company (NASDAQ: BIAF). CyPath Lung is a noninvasive test for early stage lung cancer that combines flow cytometry of a patient sputum sample with automated analysis developed by machine learning, using a fluorescent porphyrin preferentially taken up by cancer and cancer related cells. Per the company's SEC filings, AI standardizes sample data analysis and patient test results. Physicians order the test to assess patients with small indeterminate pulmonary nodules. In a clinical trial of high risk patients with nodules under 20 millimeters, the company reports 92 percent sensitivity, 87 percent specificity, 88 percent accuracy, and 99 percent negative predictive value. Marketed as a laboratory developed test through the company's own CLIA laboratory and explicitly not intended as a sole diagnostic tool.

Multi cancer early detection company (NASDAQ: GRAL). The Galleri test uses targeted methylation sequencing with machine learning to detect a cancer signal from a blood draw and predict the tissue of origin. Reported to detect signals across more than 50 cancer types. The evidence base is unusually deep for this index: PATHFINDER 2 enrolled 25,490 participants and the NHS-Galleri trial enrolled more than 140,000 asymptomatic participants in England, the only prospective randomized controlled trial of a multi cancer early detection test for population screening. GRAIL submitted the final module of its FDA Premarket Approval application for Galleri in January 2026; the test carries FDA Breakthrough Device designation (2018) and is currently offered as a laboratory developed test.

Cloud native genomics analysis company (NASDAQ: SOPH). The SOPHiA DDM platform applies machine learning with patented algorithms to call, annotate, and pre classify variants from next generation sequencing data, technology agnostic across sequencing instruments, with genomics, radiomics, and multimodal analytics modules. Deployed as software that hospitals and labs run themselves: at Mount Sinai, for example, SOPHiA provides the analytical software while the health system runs it as a laboratory developed test in its own CLIA certified, CAP accredited lab. The platform reports a network of more than 750 hospitals, academic centers, and labs and a federated learning model across participating institutions. Certain applications are research use only and regional clearance varies.

Precision medicine company (NASDAQ: TEM) whose provider software is what this index covers: Next, an AI clinical decision support system that alerts clinicians to patients who may have fallen off care guidelines, backed by a vendor reported 662 patient prospective study across six sites; Hub, a physician platform rebuilt on an agentic architecture including a prior authorization agent; and David, a generative AI clinical assistant deployed directly into the EHR, with Northwestern Medicine as the first health system. Tempus acquired Deep 6 AI in March 2025, adding a precision research platform that applies natural language processing to structured and unstructured EMR data to match patients to clinical trials in near real time and to generate real world evidence. Deep 6 reports real time EMR feeds across more than 30 health systems, an ecosystem of over 1,000 research facilities including 18 academic medical centers and 11 NCI designated cancer centers, and that sites find more than 25 percent more patients than with traditional recruitment; the company notes 92 percent of trial inclusion and exclusion criteria benefit from unstructured data and that 15 to 20 percent of eligible patients are found through unstructured data alone. Outputs are positioned as decision support requiring trial team validation before action. The sequencing and pharma services businesses are context, not indexed products.