September 15, 2017 (Vol. 37, No. 16)

Industry Watch: Helix and Illumina Partner on DNA Consumer Product Startups

Personal genomics company Helix and Illumina are partnering to support consumer genomics startups. Helix is teaming up with Illumina Accelerator to provide resources and support for innovative entrepreneurs developing DNA-driven products for the consumer market.

Illumina Accelerator claims to be the world’s first business accelerator focused on supporting genomics startups. The initiative operates on a six-monthly funding cycle to provide successful applicants with seed investment, mentoring business guidance, laboratory space in the San Francisco Bay area, and access to Illumina sequencing technologies, reagents, and software. Additional match funding can be accessed through the $40 million Illumina Acclerator Boost Capital.

Headquartered in the San Francisco Bay area, Helix was set up in 2015 with support from Illumina, which remains its largest shareholder. The latest partnership between Helix and Illuminator Accelerator will give startups that are developing consumer-centered DNA-powered products access to Helix’s specialist expertise in areas spanning next-generation sequencing (NGS), bioinformatics, applied genomics, software and product development to regulatory affairs, quality assurance, consumer marketing, and business development.

“Illumina Accelerator is focused on driving value for genomics startups by providing access to vital resources such as capital, sequencing and genomics expertise, coaching, and local lab and office space,” said Mostafa Ronaghi, Ph.D., Illumina’s senior vice president, CTO, and cofounder of Illumina Accelerator. “By working with Helix during our seventh funding cycle, select startups will have unparalleled access to Helix’s commercial market expertise and sequencing platform for their consumer applications.”

Last month, Helix launched its online consumer marketplace for personalized genomics products. Through the service, individuals can order sequencing-based genome analysis through Helix’s partners to provide insights into ancestry, family, fitness health, and nutrition. Helix first collects and sequences an individual’s DNA sample and stores the DNA so that products can be ordered from the Helix marketplace without having to provide another saliva sample. The DNA is sequenced at Helix’s accredited facilities using the firm’s next-generation sequencing (NGS) Exome+ assay, which sequences all 22,000 protein-coding genes, as well as generating additional relevant genomic information. When products are ordered through the marketplace, Helix shares the relevant DNA data with the partner company carrying out the analysis. Genetic counseling is also offered through Genome Medical. 

Discovery & Development: Drug Development in the (Organ) Chips

If organ-on-a-chip technology gives you brainwaves or makes your heart beat faster, you may want to check on its progress every so often. After all, as Roche Pharmaceutical Science’s Adrian Roth cautioned in a Nature news article a couple of years ago, inflated expectations for the technology are to be avoided. They could lead to disillusionment, particularly among pharma companies. If pharma were to decide that organ-on-chip applications were not, in fact, imminent, they could create a self-fulfilling prophecy, even in the face of optimistic market projections. (According to Research and Markets, the global organ-on-a-chip market is expected to grow at approximately 69.4% over the next decade to reach approximately $6.13 billion by 2025.)

For what it’s worth, organs-on-chips have been entering the mainstream of news, if not the mainstream of disease modeling, drug screening, or patient stratification. For example, back in April 2017, the FDA announced that it intended to use organ-on-a-chip technology to study the effects of potential chemical and biological hazards found in foods, cosmetics, or dietary supplements. The FDA added that the chips by Emulate—which were originally developed for drug testing—might work better than cell-culture or animal-based tests, at least for the agency’s purposes.

Emulate also indicated that organ chips were getting a boost from the space program. The company announced in June 2017 that it had received a grant to modify its human Brain-Chip system and create an experimental platform that could be used aboard the International Space Station.

More recent developments include news from TissUse (which licensed ProBioGen’s human lymph node technology for multi-organ-chip applications); CN Bio Innovations (which licensed a Bristol-Myers Squibb hepatitis B program to enhance its liver-on-a-chip model); and Hurel (which announced the commercial launch of its microliver testing platform).

An even more recent development: Mimetas, in collaboration with Roche, announced that it had developed a novel gut-on-a-chip system that could be used to evaluate epithelial barrier function and predict adverse drug effects. The system was described in Nature Communications, in an article entitled, “Membrane-Free Culture and Real-Time Barrier Integrity Assessment of Perfused Intestinal Epithelium Tubes.” According to Mimetas, the gut model “lends itself to assess toxicology and transport of oncological and other compounds, as well as disease-modeling studies and fundamental research.”

Genomics & Proteomics: New Partnership Set to Enhance Epigenetics Research Efforts

Two leaders in developing innovative epigenetic tools, NuGEN Technologies and Cambridge Epigenetix (CEGX), recently announced that they have entered into a strategic partnership agreement to integrate the CEGX TrueMethyl technology for oxidative bisulfite sequencing (oxBS-Seq) with NuGEN’s innovative NGS library preparation kits. The signing of the agreement will enable CEGX to focus on its epigenetic biomarker discovery programs, both in-house and in partnership with leading biopharma companies, and will further strengthen NuGEN’s epigenetics portfolio of whole-genome Methyl-Seq, reduced representation bisulfite sequencing (RRBS), and patented SPET target enrichment systems.  

“This partnership will enable both CEGX and NuGEN to leverage our strengths to facilitate advances in the epigenetics field,” remarked Jason Mellad, Ph.D., CEO at Cambridge Epigenetix, in a press release. “CEGX is committed to realizing the promise of epigenetics through the development of improved, minimally invasive diagnostic and prognostic tests for accurate and early detection of a range of diseases, including cancer. NuGEN’s reach and reputation for delivering high-quality genomics solutions to the market make them the ideal partner to further develop TrueMethyl technology to deliver a range of new products to enhance epigenetics research.”

The epigenetic DNA modifications 5-hydroxymethylcytosine (5hmC) and 5-methylcytosine (5mC) play very different roles in gene regulation. Cambridge Epigenetix enhanced the appreciation of 5hmC through the introduction of its TrueMethyl oxBS-Seq system. Their developments have enabled researchers to further elucidate the role of DNA methylation in disease occurrence and progression, highlighting the potential for such epigenetic marks in the development of improved diagnostic and prognostic assays. The integration of TrueMethyl oxBS and NuGEN’s patented library preparation technologies will broaden the scope of accessible samples for the detection of these emerging markers.

“We are delighted to be working with CEGX to provide the tools to improve the understanding and appreciation of epigenetics in cellular function,” stated Nitin Sood, Ph.D., CEO of NuGEN Technologies. “By combining the TrueMethyl oxBS technology with our NGS library preparation kits, we will provide our customers with whole genome and targeted methylation products to unlock the tremendous potential of epigenetics. The technology complements our Methyl-Seq and single primer enrichment technology product lines, and we are delighted to provide researchers with the most comprehensive solution for epigenetics research.”

Bioprocessing: Lonza Expands its Capabilities in Drug Product Services

Lonza says its Pharma & Biotech segment is expanding in parenteral dosage form development with an additional build-out of its Drug Product Services (DPS). Company officials note that the investment will enlarge both capability and capacity of DPS at the Stücki Science Park in Basel, Switzerland, including new capabilities for drug product process development.

DPS began it lab business last November initially focusing on formulation development and drug product analytical development. The facility was recently granted a GMP license after a successful audit by Swissmedic allowing QC release and stability testing of drug products.

“This significant expansion represents an important milestone in Lonza’s evolution to become a fully integrated drug development partner. With the recent acquisition of Capsule, combined with DPS’s excellence in parenterals, we offer a wide range of services to meet our customers’ drug product needs,” said Marc Funk, COO of Lonza’s Pharma & Biotech segment. “Our expansion in Basel also signals Lonza’s strong commitment to the local community.”

According to Funk, DPS’ approach to drug product development anticipates and prevents problems early and helps ensure the product is optimal for manufacture, supply chain, and patient use. A complete portfolio of services for parenteral dosage forms is available, including products for injection and infusion for intravenous, subcutaneous, and intraocular routes of administration.

These offerings also include specialized services, including particulate identification, characterization and quantification, excipient and surfactant characterization, extractable and leachables assessment, and container closure integrity testing.

“The expansion of drug product services reflects the value that Lonza brings to our pharma and biotech customers through exceptional experience, a strong scientific track record and state-of-the-art instrumental infrastructure which enables them to accelerate and de-risk Drug Product development and commercialization,” said Prof Dr. Hanns-Christian Mahler, Lonza’s head of drug product services.  

Molecular Diagnostics: At-Home Fertility Testing:

We live in an age of mobile banking, wrist-mounted pedometers, and menstruation-tracking apps. And yet, actual fertility diagnostic information is hard to come by and prohibitively expensive.

Afton Vechery and Carly Leahy recently launched Modern Fertility, a company that offers affordable, easy-to understand, at-home fertility testing. The cofounders’ former positions illustrate the aim of this company: Vechery was product manager at 23andMe, and Leahy was senior creative strategist at Uber Everything. The company aims to empower women by delivering hormone measurements, so they can make informed choices about their fertility at home, rather than having to visit a fertility clinic.

The benefits of the test include its price ($149), and its simplicity. The test measures up to 10 hormones, depending on the method of birth control the woman is using, and delivers a report that describes the implications of the levels of each hormone. Testing the hormones AMH, FSH, E2, LH, TSH, FT4, P4, PRL, FREE T, and T gives a physician-reviewed report on ovarian reserve, ovulation stability, and general body functions as they relate to fertility.

Modern Fertility is backed with $1 million from First Round Group, Box Group, Y Combinator, and angel investors. The at-home fertility tests are available for preorder and are slated for delivery later this year.  

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