ANOTHER SIGN OF HEALTHCARE’S TRANSFORMATION came on June 1 when Sysmex Corporation of Kobe, Japan, and Laboratory Corporation of America in Burlington, North Carolina, announced a unique collaboration to develop blood-based molecular diagnostic tests for cancer.
The collaboration calls for Sysmex, a major in vitro diagnostics (IVD) manufacturer with expertise in hematology testing, to work with LabCorp. Efforts will center around two assays developed at Sysmex Inostics, called OncoBEAM and Plasma-Sequencing.
These assays allow clinicians to do a molecular genetic analysis of cell-free tumor DNA from blood samples. Often called a liquid biopsy, this technology is a non-invasive method of determining the mutational status of a cancer patient’s tumor and for selecting appropriate therapeutic agents. Sysmex and LabCorp said this technology can eliminate the need for further biopsies.
An interesting twist in this story is that LabCorp can give Sysmex access to patients in clinical trials for medications that oncologists would use for cancer. That access comes through LabCorp’s recent acquisition of Covance, which it completed in February. Sysmex Inostics will provide reagents and services to allow Covance to provide OncoBEAM and plasma-sequencing testing services to support clinical trials in oncology. Also, Sysmex and LabCorp will seek ways to develop commercial applications to use Sysmex technologies in clinical diagnostics.
Another lab company working on developing liquid biopsy technology is NeoGenomics Inc., of Fort Myers, Florida. Earlier this month, NeoGenomics announced the launch of 12 liquid biopsy tests that use next-generation sequencing and other advanced molecular technologies. Called NeoLAB tests, these assays use cell-free circulating DNA and RNA in blood plasma to identify molecular abnormalities in the bone marrow without the need for a bone marrow biopsy.
Use of Blood Specimens
NeoGenomics said more than 600,000 bone marrow biopsies are done each year to diagnose and monitor treatment of patients with hematologic cancers. The new tests may eliminate the need for such biopsies. Cell-free testing is based on the concept that hematologic cells release DNA, RNA, and protein into circulation when the cells are immersed in blood. Cellfree circulating DNA, RNA and protein are called exosomes, microvesicles, apoptotic bodies, or simply DNAor RNA-protein complexes, NeoGenomics said.
The ability to use liquid biopsies successfully has been a goal of diagnostics companies because it is less invasive than traditional biopsies. Therefore, these assays could allow for earlier detection of cancer in the bloodstream before clinicians can detect a tumor.