Connection Between Epigenome, Selective Mutability, Evolution, and Human Disease
Li, Harris et al., PLoS Genetics
Researchers at the Baylor College of Medicine and elsewhere propose a "connection between the epigenome, selective mutability, evolution, and human disease" based on the findings of their study on associations of structural mutability with germline DNA methylation and with non-allelic homologous recombination mediated by low-copy repeats. "Combined evidence from four human sperm methylome maps, human genome evolution, structural polymorphisms in the human population, and previous genomic and disease studies consistently points to a strong association of germline hypomethylation and genomic instability," the Baylor-led team writes.
Quest CEO Promises 'More and More' Esoteric, Genetic Tests to Emerge
Esoteric and genetic-based tests represented 36 percent, or $665 million, of Quest's total revenue during the fourth quarter, and the company said it is taking steps to ensure those high-margin assays continue to grow.
"Revenues grew largely as a result of increased demand for … gene-based and esoteric tests, including cancer diagnostics, CEO Surya Mohapatra said in a statement yesterday.
During the firm's earning conference call in the morning, Mohapatra said that "[o]ne of the things we invested money [in was] to diversify our business [to allow] for more gene-based and esoteric and anatomic pathology" — all high-margin plays.
Today, "36 percent of Quest's business is now on high growth, high-margin business, Mohapatra said. By comparison, esoteric testing at chief rival LabCorp represents around 34 percent of total revenue.
During the call, Mohapatra added that "you will see more and more introductions of [gene and esoteric] products whether it is for colorectal cancer or for ovarian cancer." A transcript of Quest's call can be read here.
Mohapatra also said revenue from the firm's non-clinical businesses — domestic risk-assessment, clinical trials-testing, point-of-care-testing, and MedPlus businesses — grew 7 percent in the quarter year over year.
"We are going to work with the health plans to establish the reimbursement but more importantly to give a choice to the patient to have alternative tests which are more specific and more sensitive," he said.
Q4 by the Numbers
Mohapatra made his remarks after the reference lab giant reported that total revenue for the three months ended Dec. 31, 2009, increased 2.7 percent to $1.8 billion year over year. Nothing to write home about, to be sure, but better than most had anticipated considering the ongoing general economic slump.
Within that top line, clinical testing revenues grew 2.3 percent year over year; revenue per requisition increased 2.6 percent; and clinical testing volume, which is measured by the number of requisitions, fell .3 percent, Quest said.
On esoteric and gene-based testing, Mohapatra said Quest will be doing "more and more" of such tests, "whether it’s for personalized medicine or whether it is just medicine to improve specificity and sensitivity almost all aspects of cancer."
Kathleen Valentine, an investor relations spokesperson, asked by an analyst about the company's septin 9 colorectal cancer test launched earlier this month, said "[w]e are offering the test currently … and will be launching the test sometime shortly after Epigenomics" — on whose biomarker it is based — "releases its pre-sep study, which we are participating in."
She said she expects those results to be available "sometime later this year."
On Jan. 11 I reported that Quest debuted the test, which it dubbed ColoVantage, making it the first lab to offer the assay in the US. The test is based on the mSEPT9 DNA-methylation biomarker identified by Epigenomics, and is designed to interrogate the Septin 9 gene in blood plasma.
A Quest spokesperson at that time told me physicians may order ColoVantage in a number of ways, including contacting the company's Nichols Institute lab in Chantilly, Va. — which currently performs the test — and online.
"Its still early days from a launch perspective obviously," Valentine said during the conference call. "We will be working on our reimbursement strategy and specifically related to that, establishing appropriate coverage from the health plans and the government payers."
POC M&A?
During the call, an analyst asked CFO Bob Hagemann to "talk about the types of acquisitions you’ll be looking at in 2010 — is it going to be more on the gene-based and esoteric side or are you looking to just continue to expand your reach?"
According to Hagemann, "We’ll continue looking for opportunities which leverage our core competency and diagnostic testing whether that is domestic acquisitions or regional esoteric or hospital laboratories. We’ll look for opportunities to expand our point of care operations and then obviously investments which will give us access to new testing methods and technologies or licenses investments or acquisitions."
The company held around $543 million cash and equivalents as of Dec. 31, 2009. It said it expects revenue in 2010 to grow between 3 percent and 4 percent.