Put it On the Board, 4/13

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Whole-slide imaging via the cloud

Leica Biosystems announced on March 6 that Chinese physicians have access to U.S. health care organizations for real-time expert review of pathology cases via a scalable, secure medical cloud network made possible through Leica’s collaboration with Dell Healthcare and Life Sciences.

The cloud-based solution, powered by Dell’s Unified Clinical Archive, is a global, secure, and scalable IT platform.

The U.S. institutions providing pathology services are Johns Hopkins Hospital, Cleveland Clinic, Hospital of the University of Pennsylvania, Dianon/LabCorp, and ProPath.

“We are pleased to now have access to additional pathology resources,” Hongbo Li, MD, a GI pathologist and co-founder of Sinopath Diagnostics in Beijing, said in a statement. Shiang Huang, MD, founder and CEO of Kindstar Globalgene Technology, said in the statement that with demand for pathology services in China growing rapidly, “we need easier access to experts both inside and outside of China to keep up with the demand.”

August Calhoun, PhD, VP and general manager of Dell Healthcare and Life Sciences, said in the statement: “This is a prime example of how a hybrid cloud solution with application-neutral data-management capabilities can break down traditional information silos and allow health care organizations to securely manage, store, and share data to advance patient care even across great distances.”
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CPT, Z-Code identifiers to be mapped

The AMA and McKesson have entered into a licensing relationship to offer a way to identify and track molecular diagnostic tests. Under the deal, McKesson Z-Code identifiers—which are issued to each test and catalogued for reference by others—will be grouped and indexed with corresponding molecular pathology codes in the AMA’s Current Procedural Terminology code set.

The relationship will result in the creation of a new reference product that maps the Z-Code identifiers to CPT codes. The AMA will use the information that labs and manufacturers submit and then share in McKesson’s Diagnostics Exchange—a software-as-a-service catalog and shared workflow solution—to assign CPT code mappings where appropriate. Not all Z-Code identifiers will immediately map to a CPT code, and in many cases multiple Z-Code identifiers will map to a single CPT code. The new product will be available for licensing from the AMA early next year.

With the Z-Code identifiers connected to CPT codes, McKesson and the AMA say, labs will be able to identify more precisely which test was performed and then reported with the appropriate CPT code, potentially making the reimbursement process more efficient. Clinicians will be able to access the tool to help them accurately identify and select tests, and payers will have additional detailed test information to help identify the tests being performed, making it possible, McKesson and the AMA say, to track outcomes on specific tests and analyze the value of the tests.
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Roche’s Kadcyla for breast cancer approved

The FDA has approved Roche’s Kadcyla (trastuzumab emtansine or T-DM1) for the treatment of HER2-positive metastatic breast cancer in those treated previously with Herceptin (trastuzumab) and a taxane chemotherapy.

Kadcyla, the first FDA-approved antibody-drug conjugate for treating patients with HER2-positive metastatic breast cancer, consists of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of trastuzumab and DM1.

Kadcyla represents a “completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer,” Hal Barron, MD, Roche’s chief medical officer and head of global product development, said in a statement.

Roche has submitted a marketing authorization application to other regulatory authorities worldwide, including the European Medicines Agency.

The FDA approval of Kadcyla is based on results from EMILIA, an international phase three, randomized, open-label study comparing Kadcyla alone to lapatinib in combination with Xeloda (capecitabine) in 991 people with HER2-positive locally advanced breast cancer or metastatic breast cancer who had previously been treated with Herceptin and a taxane chemotherapy.Those who received Kadcyla lived a median of 5.8 months longer (overall survival) than those who received the combination of lapatinib and Xeloda. And those who received Kadcyla lived significantly longer without their disease getting worse compared with those who received lapatinib plus Xeloda (HR=0.65, 35 percent reduction in the risk of disease worsening or death, P<0.0001; median progression-free survival 9.6 months versus 6.4 months).
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FDA clears urine analyzer

The Food and Drug Administration has cleared U.S. Arkray’s Aution Hybrid AU-4050 urine analyzer. The fully automated integrated urine analyzer combines in one 32-inch × 28-inch unit the company’s urinalysis strip technology with fluorescent flow cytometry sediment analysis.

The analyzer improves sample throughput capabilities with continuous sample loading averaging a rate of 150 samples per hour. The full reflex testing capabilities allow laboratories to complete urine analysis on the same platform with minimal interaction.