Put it on the Board, 7/15

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“I want to share with you a couple of things that are going to change everything,” Dr. Tsongalis said. The first is the vast potential of the humble blood test made possible by what is being dubbed the liquid biopsy.

“This whole idea that is now catching on pretty quickly is the idea of cell-free DNA in the plasma. We’ve already seen it work very nicely for noninvasive prenatal testing, and now people are starting to look at it for other types of variants in the genes. In your plasma, there’s DNA floating around outside of a cell that represents some tissue or some cell population in your body. In cancer patients, we know that the cell-free DNA reflects the tumor, and that we can find the same mutations in the cell-free DNA that are in the patient’s tumor . . . and that will be used to monitor patients,” he said.

“This is really a game-changing type of technology for the way we assess cancer patients,” Dr. Tsongalis said.

The second trend on the rise—and one that may be even more difficult for laboratories to reckon with, he said—is the emergence of wearable and implantable diagnostics and technology that can make a diagnosis based on breath.

“Just like we can identify different compounds by mass spectrometry, in your breath there are different compounds that can mimic, or reflect, or correlate back to a particular disease process you might be experiencing,” Dr. Tsongalis said. “We have data in the laboratory now with mice . . . where we put a little cone over the mouse’s nose and they breathe into this little bag for about a minute. Then we inject that breath into a mass spectrometer and we get profiles of those different compounds . . . that allow us to determine what the bacteria is that’s infecting the mouse’s lung within three minutes.”

Moreover, chips implanted under the skin could allow for ongoing blood monitoring.

“What happens if we put probes on these chips—which we know we can do—and put those probes in and inject it, and it monitors the cell-free DNA in your plasma?” he asked. “Those are the types of things that I think will be really disruptive.”

Wearable and implantable diagnostic devices paired with smartphone technology could threaten the laboratory’s traditional role within the health care encounter, Dr. Tsongalis added.

Dr. Tsongalis

“What’s happened is that we’ve come an enormous way, and things have gotten much, much smaller, much quicker and much better. But I think the role we play in the clinical laboratory—in how things get paid for, how things get assessed, and how patients get managed—is going to change even more dramatically as our role changes from somebody that’s a keeper of specimens to somebody that’s really a keeper of data.”

On that note, Dr. Tsongalis said he and his laboratory colleagues at Dartmouth are moving into a new, 11,000-square-foot laboratory space and that 25 percent of the footprint is dedicated to data analysis.

“It looks like Central Command,” he said.—KBO’R

OPKO to buy Bio-Reference

OPKO Health and Bio-Reference Laboratories have signed a definitive merger agreement under which OPKO will acquire BRLI. Under the terms of the deal, already approved by the two companies’ boards of directors, holders of BRLI common stock will receive 2.75 shares of OPKO common stock for each share of BRLI common stock. Based on a closing price of $19.12 per share of OPKO common stock on June 3, 2015, the transaction was valued at about $1.47 billion, or $52.58 per share of BRLI common stock. The companies expect the transaction to be completed during the second half of 2015.

OPKO intends to leverage the national marketing, sales, and distribution resources of BRLI to enhance sales of its 4Kscore test—a blood test that provides a patient’s specific, personalized risk score for aggressive prostate cancer—as well as other OPKO diagnostic products under development. Through GeneDx and GenPath Diagnostics, BRLI has accumulated genetic and genomics data that OPKO plans to make available to industry and academic scientists to enhance their drug discovery and clinical trial programs.

OPKO intends to allow BRLI’s laboratory operations to continue seamlessly, but with enhancement from its pipeline of diagnostic products. The diagnostic services of OPKO will be merged with BRLI operations.

Ventana gets OK for crizotinib IHC companion Dx

Ventana Medical Systems announced the FDA’s approval of the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to help identify patients for crizotinib, marketed as Xalkori by Pfizer. The Ventana ALK Assay was approved as a CE-IVD in Europe in 2012 and by the Chinese Food and Drug Administration in 2013. With this U.S. FDA class III approval, ALK IHC testing is accessible on Ventana BenchMark immunohistochemistry instruments worldwide, can be integrated into standard lab workflow, and offers fast test results with a binary, straightforward scoring method.

“The test provides physicians and patients a fast and accurate method to identify ALK protein expression, and clinicians can be confident knowing that our FDA approval is based on data resulting from collaboration between Ventana and Pfizer,” Mary Padilla, MD, senior director of pathology and medical director for Ventana Companion Diagnostics, said in a statement. “Ventana used the Ventana ALK (D5F3) CDx Assay and scoring method to retrospectively test patient samples from Pfizer-sponsored clinical trials and demonstrated that the test is effective in identifying patients with ALK-positive NSCLC who may benefit from treatment with Xalkori.” Ventana is a member of the Roche Group.