INVITAE INC.

Company Overview

Invitae Inc., founded in 2010 as a spin-off of Genomic Health, is developing and commercializing NGS-based sequencing services for the clinical industry. Invitae has a goal of aggregating the world’s genetic tests into a single assay for a lower cost than most current single tests.

Invitae markets an NGS-based diagnostic panel that sequences more than 600 genes associated with cardiovascular disease, hereditary cancers, neuromuscular disorders, rare diseases and pediatric diseases.

Invitae is taking the strategy of offering free genetic testing in conjunction with pharmaceutical partners for rare diseases. Examples of this strategy include recent partnerships with Alnylam Pharmaceuticals, Horizon Therapeutics, Spark Therapeutics and X4 Pharmaceuticals.

In the field of cancer diagnostics, Invitae offers a wide range of assays including for hereditary cancers and for pan-cancers. The company also offers panels for prostate, colorectal, breast and brain cancers, among others.

In July 2019, Invitae acquired Jungla, an artificial intelligence-driven biotech company. The acquisition significantly strengthened Invitae’s capabilities in variant interpretation, including for cancer applications.

Also, in July 2019, Invitae began using RNA-seq as part of its program to resolve variants of unknown significance (VUS) detected by genetic tests for hereditary cancer syndromes. This provided another tool to Invitae’s variant analysis pipeline to reduce the number of variants that cannot be confidently classified based on DNA sequencing alone.

In March 2020, Invitae acquired three companies: YouScript, Genelex and Diploid. YouScript markets a clinical decision support platform to help physicians manage their patient’s medications in the context of genetic test results and can be integrated into electronic medical records. Genelex is a pharmacogenetic testing company. Diploid markets artificial intelligence software called Moon that diagnoses genetic disorders from patient’s gene sequencing and other clinical data.

These acquisitions added pharmacogenetic capabilities to Invitae and positioned it in the hereditary cancer risk testing market. The Diploid acquisition is synergistic with Invitae’s earlier acquisition of Jungla, as it strengthened Invitae’s variant classification capabilities.

The Moon platform helped Invitae to migrate larger NGS panels and exome sequencing products to a whole genome offering, as the same price.

In October 2020 Invitae acquired ArcherDx. The combined company has a strong franchise in hereditary cancer risk assessment (Invitae) and tumor profiling and liquid biopsy for predicting and monitoring therapeutic response (ArcherDx).

This acquisition expanded Invitae’s cancer genetic testing business beyond hereditary cancer risk and into tumor profiling and monitoring therapy response. ArcherDx markets Stratafide, a pan-cancer assay that identifies actionable genomic alterations from tissue and blood samples. ArcherDx also has Personalized Cancer Monitoring, a product used to predict how cancer patients respond to treatment and identifies early signs of cancer recurrence.

Archer’s RUO product lines include FusionPlex, VariantPlex, LiquidPlex and Immunoverse.

Archer Dx also has clinical diagnostic products in their development pipeline, Stratafide and Personalized Cancer Monitoring (PCM), which have both achieved Breakthrough Device designation from the FDA. Stratafide is a pan-cancer assay that finds actionable genomic alterations from tissue and blood samples. Personalized Cancer Monitoring is a product that assesses how cancer patients are responding to treatment and identifies early signs of cancer recurrence.

In May 2020, ArcherDx partnered with AstraZeneca to develop PCM assays for MRD applications in early-stage NSCLC settings. Under this agreement, ArcherDx agreed to perform WES of resected NSCLC patient samples and generate patient-specific ctDNA assays. The goal is to use these PCM assays to develop companion diagnostics for AstraZeneca’s associated therapies.

In May 2020, ArcherDx formed an alliance with Bayer to develop NGS-based companion diagnostics for Vitrakvi (Larotrectinib), the first-in-class tyrosine kinase (TRK) inhibitor approved in the U.S. and Europe for adult pediatric patients with TRK fusion cancers across all solid tumors. The main objective of this alliance is to broaden patient access to comprehensive genomic testing including NTRK1, NTRK2 and NTRK3 gene fusions and to help improve identification of appropriate treatment options for patients with TRK fusion cancer that can lead to helpful treatment options.

In January 2020, ArcherDx and Illumina partnered to co-market a portfolio of planned IVD tests; the agreement was a co-marketing partnership to drive awareness of ArcherDX IVD products and increase access to key genomic information in the community oncology care setting. The partnership expanded and built on existing agreements with Illumina including developing ArcherDx IVD tests to run on Illumina’s NextSeq 550Dx and MiSeq Dx Systems as well as a prior agreement to co-market and co-promote the Archer FusionPlex line of research products in markets outside the U.S.

In July 2019, ArcherDx formed an alliance with Ayala Pharmaceuticals covering the development of NGS-based companion diagnostics for gnomically defined, clinically underserved cancers. The focus is on companion diagnostics targeting cancers bearing Notch activation mutations and fusions.

In June 2020, ArcherDx and BristorMyersSquibb (BMS) announced a partnership to use Archer’s Personalized Cancer Monitoring (PCM) platform to detect MRD in patients treated with immunotherapy.

ArcherDx pursues a kit-based market model, versus service-based models, which differentiates it from other companies in this industry. Kit-based marketing models allow for in-house testing and control of the data.

Financial Highlights (FY 2022)

Company's Business Segments

• Oncology : Testing and treatment for various cancers such as Colorectal cancer, Breast cancer, Ovarian cancer, Prostate cancer, Pancreatic cancer.
• Women's health : This segment offers various patient tests, such as the Invitae Multi-Cancer Panel, Invitae Common Hereditary Cancers Panel, Invitae Hereditary Breast Cancer STAT Panel, Others.
• Rare diseases : There are various offerings, such as the Invitae Neurodevelopmental Disorders (NDD) Panel, the Invitae Chromosomal Microarray Analysis (CMA), the Invitae FMR1-Fragile X Syndrome and Related Disorders Repeat Expansion Test, Others.
• Data/services : Invitae provides several services, such as Educational webinars, Papers and Presentations, Sponsored Testing, Clinical Practice resources, Others.