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Put It on the Board, 2/18

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PreludeDx unveils predictive assay for DCIS

FDA OKs BRACAnalysis CDx as companion Dx for olaparib

Technopath launches anti-müllerian hormone third-party QC

FDA clears calprotectin test

New indication for Gilotrif in EGFR-mutant-positive NSCLC

FDA clearance, waiver for Strep A+ for use with Sofia 2

Illumina launches iSeq 100

Thermo Fisher, Illumina sign agreement

PreludeDx unveils predictive assay for DCIS

PreludeDx announced results from its oral presentation at the San Antonio Breast Cancer Symposium. The results using the SweDCIS randomized trial confirmed that the DCIS­ion­RT test predicts which patients with ductal carcinoma in situ will benefit from radiation therapy after breast-conserving surgery.

The results shared by SweDCIS principal investigator Fredrik Wärnberg, MD, PhD, associate professor of surgery at Uppsala University, demonstrated that DCIS­ionRT accurately stratified patients from the landmark trial into two groups: 1) a low-risk group that did not benefit from radiation therapy, and 2) an elevated-risk group with a highly significant nine percent absolute benefit from radiation therapy. According to Rakesh Patel, MD, breast cancer radiation oncologist and medical director of breast cancer services at Good Samaritan Hospital in Los Gatos, Calif., “The use of DCISionRT in this randomized trial set demonstrated twice the benefit of radiation compared to all other previous DCIS trials investigating radiation therapy benefit. This is big news to radiation oncologists and surgeons worldwide and will impact the way DCIS is managed moving forward.”

PreludeDx was founded in 2009 with technology licensed from the University of California San Francisco. Its focus has been to develop precision breast cancer tools that will have an impact on a patient’s treatment decision.
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FDA OKs BRACAnalysis CDx as companion Dx for olaparib

The FDA approved Myriad Genetics’ BRACAnalysis CDx for use as a companion diagnostic to identify patients with HER2-negative metastatic breast cancer who have a germline BRCA mutation and are candidates for treatment with the PARP inhibitor Lynparza (olaparib).

Lynparza is marketed by AstraZeneca and Merck. BRACAnalysis CDx is the first FDA-approved test for use in this indication.

“As shown in the OlympiAD study, Myriad’s BRACAnalysis CDx test was proven to accurately identify those patients who had a germline BRCA mutation and may benefit from Lynparza,” Myriad chief medical officer Johnathan Lancaster, MD, PhD, said in a statement.

The new metastatic breast cancer indication is the second FDA approval of BRACAnalysis CDx for use in conjunction with Lynparza. In 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib.
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Technopath launches anti-müllerian hormone third-party QC

Technopath Clinical Diagnostics launched its Multichem anti-müllerian hormone quality control product. Multichem AMH is intended for use as a third-party liquid frozen QC material to monitor the precision of laboratory testing procedures for anti-müllerian hormone assays.

Last fall, Technopath Clinical Diagnostics announced a joint venture agreement with Northwell Health in New York. The deal brings the two entities together as Technopath Northwell Clinical Diagnostics, which will sell and market Technopath’s Multichem quality control products and IAMQC informatics platform in the United States. Northwell Health will use the full Technopath product range in every laboratory in its health system.

“This collaboration with Technopath is an excellent opportunity to bring a high-quality product into the U.S. market to help promote cost-effective operations of clinical laboratories,” James Crawford, MD, PhD, executive director of laboratory services and chair of pathology at Northwell Health, said in a statement.
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FDA clears calprotectin test

The FDA cleared Inova Diagnostics’ Quanta Flash Calprotectin, which aids in diagnosing inflammatory bowel disease and helps differentiate IBD from irritable bowel syndrome. It is one of 29 FDA-cleared assays available on Bio-Flash, a random-access chemiluminescent instrument, and can be run simultaneously with other Quanta Flash assays.

Quanta Flash Calprotectin is the first fully automated, random-access calprotectin assay available in the U.S., according to the company.[hr]

New indication for Gilotrif in EGFR-mutant-positive NSCLC

The FDA has approved a supplemental new drug application for Boehringer Ingelheim’s Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations as detected by an FDA-approved test.

The new label includes data on three additional EGFR mutations: L861Q, G719X, and S768I. The FDA granted priority review status to Gil­otrif in evaluating this application.

Gilotrif had been approved in the U.S. for the first-line treatment of patients with NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. In addition, Gilotrif is approved in the U.S. for patients with squamous cell carcinoma of the lung whose disease has progressed after platinum-based chemotherapy.

“With this expanded indication for Gilotrif, NSCLC patients whose tumors have certain EGFR mutations now have an approved therapy that specifically targets these mutations,” Sabine Luik, MD, senior VP of medicine and regulatory affairs, Boehringer Ingelheim Pharmaceuticals, said in a statement.[hr]

FDA clearance, waiver for Strep A+ for use with Sofia 2

Quidel received 510(k) clearance and CLIA waiver from the FDA for its Sofia Strep A+ Fluorescent Immunoassay to be used with the Sofia 2 Fluorescent Immunoassay Analyzer for the rapid detection of infections by group A Streptococcus bacteria.

Sofia 2 uses the original Sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, automated, and objective result in five minutes, the company said in a statement.

Sofia 2 integrates a barcode scanner and wireless connectivity within a smaller footprint than the legacy Sofia instrument. The next-generation Sofia system also comes connected to Virena, Quidel’s data-management system.

Sofia Strep A+ is the third CLIA-waived assay on the Sofia 2 system. Sofia 2 is CLIA waived for use with the Sofia Influenza A+B assay and the Sofia RSV assay.
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Illumina launches iSeq 100

Illumina launched its iSeq 100 Sequencing System, a combination of its sequencing by synthesis chemistry and its metal-oxide-semiconductor detection technology. The iSeq 100 is the first system with this architecture and has a U.S. list price of $19,900.

Measuring one cubic foot in size, the iSeq 100 is the most compact format of any Illumina sequencer to date, the company said.

“For under $20,000, any researcher can have access to the accuracy of an Illumina sequencer in their lab,” Francis deSouza, Illumina president and CEO, said in a statement. “The iSeq 100 offers robustness and reliability for a broad range of applications ranging from germline and somatic tumor profiling to 16S microbial analysis and targeted gene expression.”
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Thermo Fisher, Illumina sign agreement

Thermo Fisher Scientific and Illumina signed a commercial agreement that enables Illumina to sell Ion AmpliSeq technology to researchers who conduct scientific studies on Illumina’s next-generation sequencing platforms.

Under the agreement, Thermo Fisher will provide Illumina with Ion AmpliSeq technology for research use. Illumina will sell the product directly to its customers under the name AmpliSeq for Illumina. Thermo Fisher will continue to sell Ion AmpliSeq chemistry for IVD and RUO applications to Ion Torrent NGS customers, and it retains the right to make the technology available on other NGS platforms.
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