CLN - Industry Playbook

Illumina, PacBio Contest U.K. Regulator’s Proposal to Prohibit Their Impending Merger

Industry Playbook: January/February 2020

Illumina and Pacific Biosciences (PacBio) are disputing a U.K. regulatory body’s determination that the anticipated merger between these two companies could weaken competition in the U.K. market for next-generation sequencing (NGS) systems. Illumina inked an agreement to acquire PacBio for approximately $1.2 billion in November 2018, and at the time, the companies expected the transaction to close sometime in 2019. However, in October of that year, the U.K. Competition and Markets Authority (CMA) came to the preliminary conclusion that the merger could result in adverse effects for the country’s NGS market, such as “reduced choice, an increase in prices, deterioration in quality, deterioration in service, and/or loss of innovation.” To prevent this, CMA proposed blocking the companies’ merger.

In response, Illumina and PacBio challenged CMA’s proposal in a November 2019 document alleging that there is no evidence supporting CMA’s supposition that Illumina’s short read systems and PacBio’s native long read systems currently compete. In particular, the document states that the regulator’s proposal fails to account for the majority of the customers CMA interviewed who said that Illumina and PacBio’s systems are not interchangeable, which suggests that they do not fall into the same product market.

Separately, Illumina and PacBio also proposed remedying any potential anticompetitive effects of their merger by providing competitors with perpetual, royalty-free licenses to any of the two companies’ pre-closing patents and patent applications. To date, though, their U.K.-based competitor Oxford Nanopore Technology has rejected this proposal.

Inflammatix Gets BARDA Funding to Develop Rapid POCT for Acute Infections

The winner of the 2019 AACC Disruptive Technology Award, Inflammatix, has entered an agreement to further develop and commercialize its point-of-care HostDx tests with funding from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. Under the terms of the deal, Inflammatix will receive $6 million in the first phase of a cost-sharing contract that is worth up to $72 million based on achieving certain milestones. The first phase of work will focus on the HostDx Fever test, which analyzes gene expression patterns in the immune system to identify in under 30 minutes whether a suspected infection is bacterial or viral. This could enable physicians to quickly determine whether or not to prescribe antibiotics. The HostDx Fever test uses fingerstick blood samples and is designed for use in primary care, urgent care, and other outpatient clinical settings.

Additionally, the contract may optionally support the development of two additional Inflammatix tests, HostDx Sepsis and HostDx FeverFlu. HostDx Sepsis will be a blood-based test that rapidly determines the likelihood that a patient has or will develop sepsis and will be designed for use in emergency department or other hospital settings. HostDx FeverFlu will be performed using nasal swab samples and will combine traditional influenza testing with host-response biomarkers. 

Wave Life Sciences Taps Asuragen for Huntington’s Disease Companion Diagnostics

Asuragen and Wave Life Sciences are collaborating to develop and commercialize companion diagnostics for Wave’s allele-selective silencing therapeutics for Huntington’s disease (HD). Wave is currently conducting Phase 1b/2a clinical trials to evaluate two HD therapeutics, the stereopure oligonucleotides WVE-120101 and WVE-120102. HD is caused by an expansion of CAG repeats in the HTT gene, and these drugs are designed to lower the mutant HTT mRNA transcript by targeting one of two single-nucleotide polymorphisms (SNPs) uniquely linked to the CAG-expanded HTT allele while leaving the wild-type transcript relatively intact. The two SNPs targeted by Wave’s therapeutics are represented alone or together in up to 70% of the HD population. Under the terms of this partnership, Asuragen will use its AmplideX polymerase chain reaction technology to develop companion diagnostics that size and phase HTT CAG repeats with the two SNP targets of Wave’s drugs. These tests could help clinicians to identify HD patients who are likely to respond to Wave’s therapeutics.

Sysmex, Biolidics Team on Liquid Biopsy Tests

The Singapore-based medical technology company Biolidics is partnering with Japan’s Sysmex Corporation to develop circulating tumor cell (CTC) assays. The new tests will use Biolidics’ ClearCell FX1 system, which is a fully automated instrument that separates and enriches cancer cells from small amounts of blood. The ClearCell FX1 takes blood samples from which the red blood cells have been removed and passes them through Biolidics’ CTChip FR1, a single-use microfluidic biochip that isolates CTCs from leukocytes. In addition to this technology, Biolidics’ and Sysmex’s new CTC assays will use Sysmex’s molecular imaging flow cytometer (MI-FCM). The MI-FCM features a special camera that produces highly detailed images of in-flow cells, as well as software that automatically analyzes these images. With this technology, the instrument is able to detect protein locations and chromosomal aberrations within a cell, enabling the precise identification of minute numbers of circulating tumor cells in the blood.

SpeeDx, QuantuMDx, and FIND Partner on Low-Cost STI Tests

SpeeDx and QuantuMDx have joined forces with the Foundation for Innovative New Diagnostics, a global nonprofit organization that aims to drive development and delivery of diagnostics to combat major diseases in resource-limited areas. The trio’s collaboration will assess the feasibility of developing low-cost point-of-care (POC) tests for common sexually transmitted infections (STIs). Under the terms of the partnership, SpeeDx will also use its PlexPCR technology to develop multiplex tests for common STIs, including gonorrhea and Mycoplasma genitalium, that will run on the QuantuMDx Q-POC device. “We are excited by this collaboration … and the potential to expand access to high-quality testing options to the areas of the world that really need it,” said Elisa Mokany, PhD, SpeeDx founder and chief technology officer. “Patients around the globe are already benefiting from the clinically relevant information provided by SpeeDx tests, but we are cognizant that the current platforms and processes in use to run these tests do not readily translate to all regions of the world.”