NEW YORK – Companion diagnostics and next-generation sequencing are becoming more and more important for diagnostics companies, and NeoGenomics is no exception.
On recent earnings calls and in documents filed with the US Securities and Exchange Commission, NeoGenomics has touted upcoming developments in both companion diagnostics and next-generation sequencing areas.
Right now, the company has about 30 companion diagnostics projects, said Scott Reid, the head of strategic alliances and CDx in the Pharma Services department at Fort Myers, Florida-based NeoGenomics. Though they keep details close to the vest until those deals are approved by the US Food and Drug Administration, there are some general signals about what the company is working on.
Recent CDx agreements include the company's collaboration with Qiagen to offer PIK3CA CDx Mutation Analysis by PCR for alpelisib (Novartis' Piqray) and another deal to join Thermo Fisher Scientific's Next Generation Sequencing Companion DX Center of Excellence Program – NeoGenomics offers Thermo Fisher's Oncomine Dx Target Test for NSCLC.
Last year, NeoGenomics signed a master service agreement with Qiagen to expedite the development and launch of CDx's with pharmaceutical partners. Qiagen agreed to provide investigational-use-only tests to NeoGenomics and other labs to run companion diagnostics in clinical trials in anticipation of regulatory approval.
Some of the CDx projects target specific mutations, while others are based on RNA expression using RT-PCR or RNA counting technology, Reid said. At least half of the projects are immunohistochemistry- or in situ hybridization-based and are used to detect expression of a protein target.
Many of these projects are a long way off, however. Reid said about 80 percent of the projects are early phase and relatively small, with the remaining 20 percent being late-phase, internationally focused, or larger in scale. For these early-phase projects, NeoGenomics handles the regulatory activities, Reid said, but for later projects it depends on the deal. For partnerships with IVD manufacturers, such as Agilent Technologies or Thermo Fisher, the IVD company handles the regulatory process. But in cases where NeoGenomics is developing the test as an FDA-approved, laboratory-developed test, the company will handle regulatory submissions and approval.
In most early-stage projects, the pharma company has approached NeoGenomics for development of the test. It usually takes three to six months before an assay is developed and sample testing can start, Reid said. However, for later-stage projects, the company is approached by both pharma and IVD manufacturers.
Regardless of who approaches first, the deals are generally fee-for-service, with pharma companies paying the development, regulatory, and commercial development costs, including clinical trials and commercialization.
The company also has plans to bring some of its laboratory-developed tests forward for FDA approval, and is expecting to launch two in 2020, pending the approval, Reid said. He declined to provide further details.
The CDx business has been a strategic focus for NeoGenomics, due in part to the publicity surrounding such deals and the additions to the company's pipeline, Reid said.
"CDx studies are high profile and provide opportunities for publicity that may not be available when providing routine diagnostic testing," said Reid. "Support for CDx studies also provides a pipeline of tests that may one day be transitioned to our clinical testing menu."
Reid refused to comment on revenue estimates or what business these CDx partnerships might bring in, but emphasized there's "enormous future potential" in the CDx space.
He also noted that the company is focusing heavily on next-generation sequencing, liquid biopsy, and multiplex-immunofluorescent based tests.
Data recently presented at conferences provides an indication of the company's CDx research interests in the personalized medicine space. Two abstracts presented at the American Society of Hematology's Annual Meeting earlier this month involved NeoGenomics researchers or tests looking at patients with acute myeloid leukemia, and another studied patients with chronic lymphocytic leukemia.
Researchers from the company also presented an abstract at the San Antonio Breast Cancer Symposium last week studying PIK3CA mutations in advanced HR+, HER2- breast cancer patients using the PIK3CA test offered by NeoGenomics and Qiagen.
Earlier this year, researchers presented an abstract at the American Society of Clinical Oncology's Annual Meeting that found NeoGenomics' "quantitative double stained immunohistochemistry assay is compatible with any two biomarkers of interest even if they're expressed on the same cell, as long as the sub-cellular localization of the markers is different."
The NGS space has also been a priority for the company in recent years. NeoGenomics' current solid tumor panel, called NeoType Discovery Profile for Solid Tumors, determines mutations in 323 genes, as well as tumor mutation burden and microsatellite instability. Earlier this year, NeoGenomics also validated a new NGS-based 297-gene panel for hematologic malignancies that analyzes both DNA and RNA, although the company is still working to validate the RNA portion. Once that is done, the firm will be able to unite the DNA and RNA analysis into a single workflow to detect mutations and gene fusions simultaneously.
The company is also working on a new solid tumor NGS panel, which will also combine DNA and RNA analysis, as well as a liquid biopsy panel. NeoGenomics CMO Lawrence Weiss said the liquid biopsy panel will likely launch by the end of the first quarter of 2020 and will look at approximately 50 genes. The solid tumor panel is also expected to launch in 2020.
Of these panels, Weiss said the company is looking to submit one to the FDA for approval, but wouldn't specify which panel would be submitted – just that it would be either a panel the company has already launched or one that is coming out in 2020.
The new assays will be run on Illumina's NovaSeq NGS system, Weiss said, which the company uses for most of its assays, although it does use Thermo Fisher's Oncomine assay for lung cancer on a Thermo Fisher sequencer. NeoGenomics is currently only analyzing tumor tissue by NGS but has longer-term plans to include normal tissue, too, Weiss said.
The company also has multiple panels of 20 to 40 genes, called Neotypes, to parse out to specific types of tumors, including lung, breast, and colon.
NeoGenomics hasn't abandoned single-gene testing, Weiss pointed out, but it currently has no plans to expand its offerings in that space.
Bill Bonnello, the company's chief strategy and corporate development officer, noted that NeoGenomics' broad reach to oncologists and pathologists, as well as its access to large amounts of oncology-specific test result data, put it in a position to make a significant impact in these arenas.
"Few labs have our same ability to take an oncology companion test across the continuum from development, through clinical trials, and into the market," Bonnello said.