Personalis, Inc. (NASDAQ: PSNL)

Personalis, Inc. (PSNL) is a biotechnology company that operates in the clinical diagnostics market, developing and marketing advanced cancer genomic tests and analytics. The company's primary business activities involve providing sequencing and data analysis services, as well as partnering with pharmaceutical companies and research institutions. Personalis' operations span across various countries, with a significant focus on the United States.

The company generates revenue through the sale of its sequencing and data analysis services, as well as through partnerships with pharmaceutical companies and research institutions. Personalis' primary products include NeXT Personal, NeXT ImmunoID, NeXT Personal Dx, and NeXT Dx. NeXT Personal is a tumor-informed liquid biopsy test for the detection of minimal residual disease and recurrence in cancer. NeXT ImmunoID is a tissue-based test that combines whole exome and whole transcriptome sequencing data with advanced analytics to provide a multi-dimensional view of the tumor and the tumor microenvironment. NeXT Personal Dx is a tumor-informed liquid biopsy test for the detection of minimal residual disease and recurrence in cancer, and NeXT Dx is a comprehensive tumor profiling test that unlocks the entire exome and transcriptome with matched tumor-normal analysis.

Personalis holds a strong position within the industry, boasting a patent portfolio of 27 issued U.S. patents and 14 issued foreign patents. The company's patent strategy focuses on securing coverage for its core technology, including applications and implementations for enhancing sequencing coverage of certain genomic regions, identifying neoantigens, analyzing cell-free nucleic acids, and creating personalized cancer recurrence detection assays. The clinical diagnostics market is highly competitive and subject to significant regulatory requirements, with Personalis' principal competitors including Adela, Inc., BostonGene Corporation, Caris Life Sciences, Inc., Foresight Diagnostics Inc., Freenome, Inc., Fulgent Genetics, Inc., Geneseeq Technology Inc., GRAIL, Guardant Health, Inc., Haystack Oncology, Inc., Illumina, Inc., MedGenome Inc., Myriad Genetics, Inc., Natera, NeoGenomics, Inc., Novogene Corporation, Predicine, Inc., Roche Molecular Systems, Inc., and Veracyte, Inc.

Personalis' customer base includes Natera, Inc., which accounted for 43%, 41%, and 10% of its revenue for the years ended December 31, 2023, 2022, and 2021, respectively, and the U.S. Department of Veterans Affairs Million Veteran Program (VA MVP), which accounted for 13%, 13%, and 53% of its revenue for the years ended December 31, 2023, 2022, and 2021, respectively.

The company's brand names and/or trade names of its products and services include NeXT Personal, NeXT ImmunoID, NeXT Personal Dx, and NeXT Dx. Personalis' sequencing and data analysis services cater to the oncology market, providing critical information to healthcare providers and researchers to aid in the diagnosis, treatment, and management of cancer. The company is committed to ensuring the integrity and confidentiality of patient data and is subject to HIPAA and HITECH regulations. Personalis has implemented policies and procedures to ensure compliance with these regulations, including the use of secure data transmission and storage protocols, access controls, and employee training.

In addition to its focus on patient data confidentiality, Personalis is committed to ensuring the safety and health of its employees. The company offers competitive total rewards programs, ongoing training and development, and a commitment to diversity by including broader outreach and sourcing for candidates for new roles as well as education and a visible commitment to diversity and inclusion internally. Personalis operates in a highly competitive and regulated market, subject to various federal and state healthcare laws, including the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the College of American Pathologists (CAP) accreditation. The company is also subject to the Federal Food, Drug and Cosmetic Act (FDC Act) and the regulations of the U.S. Food and Drug Administration (FDA), requiring it to obtain premarket clearance or approval for its tests and associated software, and subject to ongoing regulatory requirements such as registration and listing requirements, medical device reporting requirements, and quality control requirements.