Put It on the Board, 10/17

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FDA clears Idylla respiratory panel

The FDA has granted 510(k) clearance for the Idylla Respiratory (IFV-RSV) Panel, a fully automated molecular diagnostic test, developed by Janssen Diagnostics, LLC. The Idylla respiratory panel runs on the Biocartis Idylla platform.
Janssen led the submission process of this premarket notification and developed the test intended for the detection of various strains of influenza virus and respiratory syncytial virus, using Biocartis’ Idylla platform. Biocartis says the panel can be performed in about 50 minutes, requires less than two minutes hands-on time, and operates from nasopharyngeal swab samples in viral transport media.
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Dako PD-L1 IHC 28-8 PharmDx approved for new indications

The FDA has approved the PD-L1 IHC 28-8 PharmDx for use in cases of urothelial carcinoma and of squamous cell carcinoma of the head and neck.

The test had previously been approved for melanoma and for non-squamous, non-small cell lung cancer. PD-L1 IHC 28-8 PharmDx was developed in collaboration with Bristol-Myers Squibb.

Opdivo (nivolumab) is an immunotherapy developed by BMS and approved in these indications regardless of PD-L1 status. While the test is not required for treatment, with these latest indications, pathologists now have access to a clinically validated complementary test to determine tumor PD-L1 status.

Data from a pre-specified exploratory analysis of the CHECKMATE-141 clinical trial showed that tumor PD-L1 expression, as detected by PD-L1 IHC 28-8 PharmDx in SCC of the head and neck, may be associated with an enhanced survival benefit for the patient from the use of Opdivo. Data from CHECKMATE-275 showed that tumor PD-L1 expression assessed by PD-L1 IHC 28-8 PharmDx may help inform which urothelial carcinoma patients are more likely to respond to Opdivo.

A positive coverage decision for NanoString’s Prosigna

NanoString Technologies announced that Anthem issued a positive coverage decision for the Prosigna Breast Cancer Gene Signature Assay. Nano­String says the decision is in line with ASCO guidelines released in 2016, which recommend the use of the Prosigna assay to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer with known hormone receptor and HER2 status.

The assay provides a risk category and numerical score for assessing the risk of distant recurrence of disease at 10 years in postmenopausal women with node-negative or node-positive hormone receptor-positive breast cancer.
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Genomic Health, Biocartis to develop IVD Oncotype DX

Genomic Health and Biocartis have agreed to develop an in vitro diagnostic version of the Oncotype DX Breast Recurrence Score test on Biocartis’ Idylla platform.

“We are excited to augment our successful U.S. centralized laboratory business model with an IVD system that can be implemented by local laboratories to increase global patient access to standard of care testing with the Oncotype DX Breast Recurrence Score test planned for launch in Europe, beginning with France and Germany, in 2019,” Frederic Pla, PhD, Genomic Health’s chief business and product development officer, said in a statement.

Development is expected to begin late this year.
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Horizon launches CRISPRi, CRISPRa screening

Horizon Discovery has expanded its functional genomic screening portfolio to include first-to-market CRISPRi (interference) and CRISPRa (activation) screening services.

Although functional genomic screening using CRISPR gene knockout technology has provided a way to identify and validate novel drug targets, and to elucidate unknown drug mechanisms, there are biological studies for which CRISPR knockout screens are not appropriate. Horizon’s CRISPRi/CRISPRa screening platform substantially broadens the range of possible studies through the capacity to reduce or increase, rather than eliminate, gene expression. This enables customers to address critical gaps in target ID and validation as they work to develop novel and more effective drug therapies. [hr]