CLN - Feature

Test Identifies Low HER2 Metastatic Breast Cancer Patients Eligible for Enhertu

Regulatory Roundup: January/February 2023

The Food and Drug Administration has approved Roche Diagnostics’ Pathway anti-HER2/neu (4B5) rabbit monoclonal primary antibody to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. Enhertu is an engineered HER2-directed antibody drug conjugate that AstraZeneca and Daiichi Sankyo are jointly developing and commercializing.

Clinicians typically evaluate or score the level of HER2 receptor protein expressed in breast cancer tissue samples. If a patient’s tumor expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment. However, half of all patients with metastatic breast cancer express low levels of HER2, which historically classified them as HER2-negative. The Pathway anti-HER2 (4B5) test includes a scoring algorithm that helps identify low expressors of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test can identify patients who may benefit from Enhertu treatment.

A recent clinical trial used the Pathway anti-HER2 (4B5) test to identify patients whose tumors expressed low levels of HER2 protein. The trial reported a 50% reduction in the risk of disease recurrence or death and an overall gain of 6 months over standard of care in patients treated with Enhertu whose tumors had low levels of HER2 expression.

FDA CLEARS FIRST IMMUNOHISTOCHEMISTRY LAB REFERENCE STANDARDS FOR BREAST CANCERS

Boston Cell Standards has received Food and Drug Administration 510(k) clearance for its IHControls panel (HER2/ER/PR), a set of immunohistochemistry (IHC) laboratory reference standards for evaluating breast cancers. The panel provides a reproducible, cost-effective solution for on-slide quality control to safeguard against potential incorrect results and to increase physician confidence in making diagnoses and selecting treatments. The standardization could improve detection of low estrogen receptor-expressing tumors especially, the company said.

Currently, IHC lacks analytic reference standards. As a result, labs often return different results from the same sample. To address this deficiency, Boston Cell Standards developed IHC reference materials, including linear range on-slide controls (IHControls) for verification of IHC assay accuracy and calibrators (IHCalibrators) with units of measure traceable to objective, quantitative standards. IHControls detect variation in IHC reagents, instruments, or protocols with high sensitivity because the control concentration is consistently matched to the assay. Boston Cell Standards officials expect this quantitative approach to calibrators and controls to improve quality and reduce laboratory costs compared with other controls.

CE MARK GRANTED TO THERMO FISHER SCIENTIFIC’S PANEL FOR COMMON GI BACTERIA

Thermo Fisher Scientific has received the CE mark for the TaqPath Enteric Bacterial Select panel, which is designed to detect common gastrointestinal (GI) bacteria and help clinicians to identify the root cause of an infection and administer the most appropriate treatment to their patients more quickly. The new test uses PCR to analyze stool samples for a range of GI bacteria, including Salmonella spp, Shigella spp./enteroinvasive E. coli, Campylobacter jejuni, Campylobacter coli, and Campylobacter upsaliensis. It returns results in about 2 hours with more than 98% sensitivity and specificity.

SIEMENS HEALTHINEERS ASSAY ADVANCES DIAGNOSTICS FOR BLEEDING DISORDER

The Food and Drug Administration has granted de novo marketing approval to Siemens Healthineers’s Innovance VWF Ac assay, a fully automated assay for detecting von Willebrand disease (VWD), the most common inherited bleeding disorder. According to the company, the Innovance VWF Ac assay is the only fully automated, commercially available von Willebrand factor (VWF) activity assay for laboratories in the U.S. that uses VWF:GPIbM technology. This means it directly measures the platelet binding activity of VWF without the need for ristocetin, which is the approach recommended by the most recent guidelines from the International Society on Thrombosis and Hemostasis.

The assay is now available to U.S. laboratories for use on the Siemens Healthineers BCS XP system, as well as on the Sysmex CS-2500 and CS-5100 hemostasis analyzers. It offers a broad measuring range with a lower limit of quantitation compared with the ristocetin cofactor assay for VWF activity.

FDA CLEARS PROCESSOR FOR PREPARATION OF MICROBIAL SUSPENSIONS FOR ANTIBIOTIC SUSCEPTIBILITY TESTING

Copan Diagnostics has received a second Food and Drug Administration (FDA) clearance for Colibrí, a semiautomated preanalytical processor and a complementary part of WASPLab, Copan’s full laboratory automation system. This most recent clearance is for the preparation of microbial suspensions for antibiotic susceptibility testing (AST) with bioMérieux Vitek 2. Previously, Colibrí also received FDA clearance in 2021 for preparation of matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) identification targets and creating bacterial suspensions for AST. This most recent clearance makes Colibrí the first instrument in its class to receive 510(k) clearance for simultaneous preparation of MALDI-TOF slides and McFarland AST suspensions.

AI TOOL TO OPTIMIZE DEPRESSION TREATMENT GETS CE MARK

Genetika+ has received the CE mark for NeuroKaire, a blood test designed to help physicians prescribe the most effective antidepressant to major depressive disorder (MDD) patients. Genetika+ aims to apply precision medicine to mental health through proprietary artificial intelligence (AI)-driven biomarkers from the company’s “brain-in-a-dish” platform combined with pharmacogenetics and clinical data. NeuroKaire is the result of training on data from MDD patients that combine microscopy, sequencing, and clinical data using state-of-the-art AI and machine learning techniques.

The CE mark was granted to NeuroKaire following a multisite study demonstrating the test’s high accuracy in predicting drug response for patients with MDD. The study followed patients treated with antidepressants for 12 weeks and included drug switches as well as response recording.

ASCENDAS GENOMICS RECEIVES CHINESE APPROVAL TO USE STANDARD BIOTOOLS’S MICROFLUIDICS TECHNOLOGY

China’s National Medical Products Administration has given approval to Ascendas Genomics, a Chinese molecular diagnostics company, to use the U.S.-based company Standard BioTools’s Biomark family of systems and Juno system. The Biomark systems are real-time PCR instruments, while the Juno system is designed for targeted DNA next-generation sequencing library preparation. Both systems use microfluidics technologies. This approval will enable Ascendas Genomics to further develop and commercialize molecular diagnostic systems and assays in China using the microfluidics technologies included in Standard BioTools’s systems.

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