Sysmex joins Lab 2.0
October 2019—Sysmex America has joined the Clinical Lab 2.0 movement to support collaboration around value-based health care. The company said it is providing a grant focused on a multi-institutional demonstration project to develop actionable clinical strategies for anemia early detection, intervention, and prevention.
Clinical Lab 2.0 is a Project Santa Fe Foundation initiative established to help develop the evidence base for the valuation of clinical laboratory services. It is a call for laboratory leadership in managing population health and enabling value-based care to evolve. Sysmex is the first corporate sponsor.
“The Clinical Lab 2.0 movement, with its critical measurable and actionable attributes, promotes the clinical and business model of the future for clinical laboratories,” Khosrow Shotorbani, president and executive director of Project Santa Fe Foundation, said in a statement.
The third annual Clinical Lab 2.0 Workshop will take place Nov. 3–5 in Chicago (www.cl2lab.org/clinical-lab-2-0-3rd-annual-workshop-registration-2-2/).
AMP recommends pharmacogenomic testing best practices
The Association for Molecular Pathology published on Sept. 4 a new position statement for pharmacogenomic testing. The statement is based on a recent assessment of the market landscape, the AMP says, and includes a list of criteria for laboratories to follow to ensure responsible use of pharmacogenomic tests, preserve broad access, and improve patient care.
The AMP recommends that laboratories providing pharmacogenomic tests adhere to the following conditions:
- All health-related pharmacogenomic claims must have well-established clinical validity.
- The pharmacogenomic testing provider must comply with the CLIA statute and regulations.
- The pharmacogenomic test report should be comprehensible by health care providers with no medical genetics or pharmacogenomics training and include the interpretation of the findings, significance of the results, and limitations of the test.
The AMP supports the practice of including the following information in the test report within the interpretation of the findings and the significance of the pharmacogenomic test results:
- A statement of the metabolizer status determined by the genotype for the genes that affect drug metabolism.
- A list of the drugs for which responsiveness may be affected by the genotype.
- A generalized statement to alert health care providers when alternative dosage or drug treatment may be considered based on the results.
- A list of resources and references that the provider can use to learn more about the genotyping result, the drug-gene association, and how to incorporate the result into actionable decisions. These resources can include pointing providers to Clinical Pharmacogenetics Implementation Consortium guidelines, peer-reviewed literature, or both.
- The AMP strongly recommends that patients not change their treatment plan without first talking to their health care provider.
FDA approves Cobas Babesia
Roche received approval from the Food and Drug Administration for the Cobas Babesia test for use on the Cobas 6800/8800 systems for individual blood donation testing. This is Roche’s first commercially available whole blood test to screen donations and follows May 2019 FDA updated industry guidance recommending screening and testing for Babesia.
The test is able to detect the four common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself.
PD-L1 (SP142) assay launched in CE markets
Roche announced in August the expanded use of the Ventana PD-L1 (SP142) assay in triple-negative breast cancer for patients living in CE markets where the Roche cancer immunotherapy medicine Tecentriq is approved. It is the first companion diagnostic to aid in identifying triple-negative breast cancer patients eligible for treatment with Tecentriq (atezolizumab) plus chemotherapy (nab-paclitaxel).
The Food and Drug Administration approved the assay in March this year as the first companion diagnostic to identify triple-negative breast cancer patients eligible for the Tecentriq combination.
FDA clears Xpert BCR-ABL Ultra
Cepheid received clearance from the FDA for Xpert BCR-ABL Ultra for monitoring disease burden in patients with chronic myeloid leukemia. It is the first FDA-cleared test of its kind capable of delivering accurate molecular results from whole blood samples in under three hours, Cepheid said in an Oct. 2 release.
“Until now, tests for BCR-ABL have not been automated or designed to be run on-demand, which has limited the potential impact of a same-day result in the management of CML patients,” David Persing, MD, PhD, Cepheid’s chief medical and technology officer, said in the release. “Because Xpert BCR-ABL Ultra is aligned to the International Scale on a lot-to-lot basis, accuracy and comparability of results are assured no matter which lab or even where in the world the test is performed. In addition, the added sensitivity provides physicians with the information they need to confidently optimize individual treatment strategies for their patients with CML, including identifying patients who might be considered for a trial of therapy discontinuation.”