Clinical OMICS

JAN-FEB 2017

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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www.clinicalomics.com January/February 2017 Clinical OMICs 35 "Hospital administrators will say, 'We're not making any money on these tests. We can't afford it.' And that might lead to those samples being sent to a commercial lab instead," said Dr. Koch. Even with extra activity, he added, commercial labs will face the added expense of PAMA compliance, money for which would likely be diverted from reimbursement of providers. At BioReference, Dr. Weisberger said up to three data analytic spe- cialists have been pulled from daily duties to assemble data in a timely fashion: "It will take them approximately 3 to 4 months to parse the collected data. The cost for their time is probably north of $100,000." To comply with PAMA, labs first need a revenue cycle man- agement system capable of track- ing and extrapolating their data. Until now, many labs have lacked such sophisticated systems, with some relying on spreadsheets, said Rina Wolf, vice president, com- mercialization strategies, consulting & industry affairs with XIFIN. CMS has projected a $390 million savings to Medicare in Part B program payments for CLFS tests in Fiscal Year 2018, and a $3.93 billion savings over 10 years. "We would still have to draw blood from the patient, so the drawing cost is not reduced," Dr. Koch said. "But now, we'll have to transport those samples from the hospital to the pickup center or get them to the commercial lab, so those logistic costs go up." "That process of sending samples to commercial laboratories will slow down patient-care decision-making, and that's going to be detrimental to patients." Two Pore Guys Turns to UCSF to Evaluate ctDNA Detection Two Pore Guys (2PG), a California-based company, released information about its intent to collaborate with oncologists at the University of California, San Fran- cisco (UCSF) in January. 2PG's technology employs solid-state nanopores, in con- junction with existing biochemical reagents, to detect a variety of analytes with single-molecule resolution, on a handheld, battery-operated device. When an analyte passes through the nanopore, it causes a measurable disrup- tion in the electrical current applied to the silicon chip. Each molecule produces a small background signal. 2PG uses existing bio- logical reagents that will bind the analyte to attach a larger scaffold that impedes the electrical cur- rent and generates a large, distinguishable signal. The ability to distinguish these larger signals from background molecules makes it possible to analyze biological samples, such as blood, saliva, or urine, without upstream sample preparation. The collaboration will evaluate the platform's potential utility in the detection of cell-free, circu- lating tumor DNA (ctDNA) from patient blood and urine samples by screening for the KRAS G12D mutation. Liquid biopsies offer a non-invasive method to monitor cancer progression, and 2PG's handheld platform could enable patients to perform testing on a routine basis from their own home. "Cancer recurrence is a constant battle, and treatment is a race against time," commented Andrew Ko, M.D., professor of hematology at UCSF in 2PG's press release. "The sooner we can detect a recurrence, the sooner we can change or aug- ment a patient's therapy and improve his or her chances of survival." According to Dan Heller, CEO of 2PG, the company's patented protocol for chemically modifying conjugate molecules means "all existing diagnostic assays can be used in our platform," and that means ctDNA detection is just the tip of the iceberg. The company isn't targeting specific applications. "We're allowing customers to be more about that," stated Heller, who likened the company's business model to Apple's App Store where they provide the hardware, the devices, and test strips, but other companies will provide the apps, the reagents and assays. As a result, partnerships, like the UCSF col- laboration, will determine if this small device will be making big waves in the medical field. —Meghaan Ferreira Dan Heller is CEO of 2PG, makers of a digital, hand-held testing platform which they say is as accurate as medical lab equipment, but is as inexpensive and easy to use as a blood glucose monitor.

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