diagnostics

Pillar Biosciences at Association for Molecular Pathology #AMP2017

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While at the Association for Molecular Pathology in Salt Lake City Utah, I was able to interview Gang Song CEO of Pillar Biosciences to ask him about the challenges in the clinical laboratory that Pillar is tackling, about the basics of SLIMamp technology, and recent news. Check it out! #AMP2017

Preview of Association for Molecular Pathology 2017 #AMP2017

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With over 2000 clinical laboratory professionals in molecular diagnostics and pathology, plenty of technology and offerings on display. This year the Association for Molecular Pathology takes place in Salt Lake City Utah, and promises an abundance of new technology as well as the new accompanying science around diagnostic testing. Since this is a molecular pathology … Read more

SlipChip technology for digital PCR

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Executive “TL;DR” Summary: An interesting platform called SlipChip with potential point-of-care applications, for fast and potentially very inexpensive digital PCR Update: This work has been recently published (Oct 2017) in Science Translational Medicine. While at the recent Next Generation Diagnostics Summit (organized by the Cambridge Healthtech Institute and held in Washington DC August 15-18 2017), … Read more

Cancer immunotherapy combination trials and a failure of the free market

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What happens when commercial interests do not align? Over a decade ago in 2002 when Novartis announced it was moving its global headquarters to Boston MA, it was viewed at the time that the United State’s pharmaceutical market was the most robust and attractive, and it made sense for Novartis to have a major presence … Read more

The immune system and cancer immunotherapy

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A ‘gold rush’ multi-billion dollar business, three targets, four cancer drugs, four antibody-based companion diagnostic tests, sixteen FDA approvals The human immune system is remarkable. When you think about the preponderance of death by infectious disease throughout history, the top two causes of death in 1900 was influenza and pneumonia, followed by tuberculosis, at 202 … Read more

SeraCare Precision Oncology

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Seracare precision medicine ngs control reference material seraseq mutation mix
The Seraseq Solid Tumor Mutation Mix-I (AF20), the first product from SeraCare’s Precision Medicine Group

This post is about Seracare’s new direction for Precision Medicine (in particular Precision Oncology), and the launch of a new product the Seraseq Solid Tumor Mutation Mix-I (AF20). But I’ll start first with a story from my days at Illumina.

It was ten years ago this week that I last launched a product. It was the Illumina Infinium Human-1 Genotyping BeadChip, and it took months of hard work, many core-team meetings, plenty of long days and many hallway discussions about the finest details of the product. Long days and many meetings go together: how can you get the things you commit to in a meeting ever done if you go to many meetings?

And in case anyone is wondering, yes that is the job of a Product Manager – you get to work hard and work closely with a team from across different areas of the company (research, manufacturing, quality, support, and engineering) and you get to experience many ups-and-downs, and learn things about yourself and others through this experience that you carry with you. These may be hard days, but they are good ones.

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FDA Approval for the MiSeq

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For Research Use OnlyCongratulations are in order to the US Food and Drug Administration for approving the Illumina MiSeqDx™ system,  including two Cystic Fibrosis assays, and two additional approvals for the platform (the instrument and the reagents). This is the first next-generation sequencer approved by the FDA, an important milestone reflecting a sea-change in how genetics and genomics is revolutionizing healthcare. The genetics revolution has been taking place for some time now – here’s a handy FDA table of over 200 pharmacogenomic biomarkers in drug labeling – but with the advent of NGS the ability to determine multiple biomarker genes via a simple electronic query is only one of several promising applications with direct clinical impact and utility.

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Personal Genomics and the Future of Healthcare

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“The future is already here – it is just not very evenly distributed.” William Gibson, author of Neuromancer and the person who coined the term ‘cyberspace’. Way back in 2006 or so when I was working for Illumina, the personal genetics firm 23andMe launched their whole-genome genotyping service (called ‘Genetic Testing for Health, Disease and Ancestry’ … Read more

Single molecule in-situ RNA startup Advanced Cell Diagnostics

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Biopsy of skin sample courtesy of euthman via Flickr
Biopsy of skin sample courtesy of euthman via Flickr

FFPE (Formalin-fixed paraffin embedded) tissues are standard preparations in the clinical world. It has been estimated that there are millions of FFPE samples stored in countless hospital laboratories and research pathology groups, all part of a standard operating procedure among pathologists and other hospital personnel. These tissue samples are embedded in paraffin blocks for indefinite room-temperature storage and are easily handled, and standard staining and microscopy techniques can then be employed to determine cancer stage, for example.

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A Revolution in Prenatal Diagnostics

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Photo courtesy of <a href=”http://www.flickr.com/photos/o5com/”>o5com</a> via Flickr.

Every mother-to-be who has what is considered an ‘at-risk’ pregnancy is informed of the risks to the fetus of a genetic abnormality. ‘At-risk’ can involve a long list of medical conditions (diabetes or cancer for example) or poor health choices (illegal drug use or smoking). Yet a common cause of an at-risk pregnancy is age, having a child before the age of 17 or older than 35. In the US, no less than 750,000 are considered at-risk.

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