Insights from Molecular Medicine Tri-Conference

At the Molecular Medicine Tri-Conference in San Francisco earlier this month, Invetech molecular biologist, Rebecca Newman attended to explore some of the current and future trends in molecular medicine that were included in the program, and to report on the highlights of the event.

What she discovered was an assembly of engaging speakers and leaders in the field of molecular biology delivering stimulating presentations, round table discussions and posters. Following are her highlights of the conference.

PCR for Molecular Medicine Symposia

Dr Carl Wittwer – Extreme PCR

Focused on increasing the speed and performance of targeted DNA diagnostics, Dr. Carl Wittwer (Pathology, University of Utah) demonstrated how to achieve extreme PCR (completing in one minute what would normally take 30-45 minutes) on a 49 base pair fragment using two hot water baths, a capillary tube and a stepper motor. With his test bed, he showed how he could complete 30 cycles in the same time as it takes conventional PCR to complete two cycles. To achieve the extreme speed on a molecular level, he increased primer and polymerase concentrations twenty-fold without sacrificing specificity or yield. Dr. Wittwer pointed out that one of the main Impediments to advancing PCR technology is limitations of the instrumentation, not the chemistry. My key take home message is that this technology could be adapted as a rapid Point of Care diagnostic device by combining it with some very simple sample prep technology.

Point of Care Diagnostics Symposia

A Point of Care (POC) Diagnostics Symposia dominated one of the days of the conference and offered cogent presentations on many Point of Care topics, specifically:

Dr. Valerie Ng – User Perspective on Point of Care Devices

Dr. Valerie Ng (Alameda Health System/Highland General Hospital) presented a user perspective on the pitfalls of applying at-home POC tests in a laboratory setting and the importance of targeted design for the appropriate usage environment. In particular, she discussed how easily user errors are made, particularly when using lateral flow and dipstick-type tests originally developed for home use. Using a variety of examples Dr. Ng showed how lab personnel can, due to workload pressure and training gaps sometimes follow instructions poorly resulting in leaving tests for longer than guidelines dictate, tilting test devices incorrectly and using more sample than necessary.

A key takeaway was that you must consider the user scenarios when designing POC devices and tests, and make early prototypes available to labs to evaluate real world usage before deciding on the final product configuration.

Dr. Donald Klepser – The Role of Community Clinics in Point of Care Testing

Dr Klepser (University of Nebraska Medical Center, College of Pharmacy) explored how pharmacies could use POC diagnostics to help ease the load on hospitals and medical clinics. As economic pressures mount in healthcare, pharmacies are finding themselves providing the role of a de facto community clinic, giving medical advice to their customers such as recommending OTC medicine for flu, colds, headaches, etc. Dr. Klepser explored how the development of point-of-care diagnostic tests could enable pharmacists to assist with patient management and provide cost-effective care by using POC tests to quickly perform flu, Strep A or HIV tests and either treat on the spot or refer the person to a doctor. They could even perform monitoring of HIV viral loads and heart attack markers, reducing the need for hospital visits for patients to get their medicine or take medicine unnecessarily. Dr. Klepser shared some practical aspects of implementing point-of-care testing in pharmacies suggesting that these types of “community clinics” in both the developed and the developing world could achieve greater accuracy, timeliness, convenience and cost improvements.

Key takeaway: Pharmacies already have the existing infrastructure to enable this treatment model. And it would be cost effective considering, for example, that about 1.8-3.6 million children a year in the US come down with Strep A pharyngitis. Early detection improves prognosis and placing these technologies in pharmacies can have a significant effect on improving health outcomes, reducing the cost of treatment and burdens placed on hospital emergency departments.

Dr. Rahul Dhanda – What if Point of Care is not the answer?

Commercial data must be used to drive go-to market decisions when developing new diagnostic platform technologies. Dr. Rahul Dhanda (VP Marketing, T2 Biosystems Inc) gave an especially interesting talk about identifying competitive advantages for novel platform technologies in clinical markets. He talked about how T2 Biosystems’ T2MR sepsis detection technology was originally thought most applicable to the POC market, but ultimately became a core lab diagnostic platform as a result of extensive data analysis of markets, technical and regulatory considerations. His message was “always use data to drive decisions” and to illustrate the point, he outlined many go-to-market decisions and criteria for bringing a device successfully to market. Dr. Dhanda’s insights will be very useful in helping convince companies to take a second look at their market data to determine where their instrument or particular technology belongs.

Biocartis New Products Showcase

Biocartis showcased three upcoming platforms that were very impressive from a user perspective.

Of most interest was the new Idylla™ platform, a system that detects KRAS and BRAF mutations. It was a compelling example of how an instrument can be designed to be a simple (minimal steps) and user-friendly solution to a normally quite complex extraction problem. The simple process included adding an FFPE tissue curl into a cartridge, closing the lid, placing the cartridge in the instrument and pressing start. Particularly impressive aspects of the instrument were the advanced lysis process and a powerful amplification technique together with the obvious attention to design for usability. The second platform shown was the upcoming Evalution™, which is a new generation biomarker analysis platform with an integrated reaction and detection environment with flexible capabilities in both protein and nucleic acid biomarker assays. The Evalution™ also has a very simple workflow that starts with preparing the reagents and microfluidic assay plates, then insert a plate and running the assay. The third device from Biocartis is their pathogen enrichment platform which will accelerate sepsis diagnostic research and is compatible with the Idylla™. Biocartis has minimized hands-on time through a simple workflow and contamination free, direct insertion of the blood tube into a gamma irradiated cartridge, providing sample enrichment in only 30 minutes with all reagents on board.

From a lab scientist’s perspective, the three platforms from Biocartis really impressed because of the extensive thought that has gone into simplifying user interactions–Biocartis has gone to great lengths to improve laboratory work flows through these developments

Insights into DNA Methylation

Dr Peter Jones (Distinguished Prof, University of Southern California) and Dr Gerd Pfeiffer Prof & Chair, City of Hope Beckman Research Institute on DNA methylation discussed and explored possible new DNA Methylation (epigenetic) biomarkers that will have a huge impact on companion diagnostics. In particular, they discussed how DNA Methylation impacts tumor growth and how we will soon be able to better understand the behavior of cancerous tumors, why someone got cancer in the first place, how the cancer is behaving under treatment, and predict/better understand the prognosis for the patient using these epigenetic biomarkers. For the future, there is great scope for securing IP in developing instrumentation to detect these panels of biomarkers

Final Thoughts

In thinking about all of the presentations, table discussions, exhibitor product displays, symposia and posters, Rebecca left the conference very excited about the future of molecular medicine and armed with insightful knowledge for the next products she will be developing for her clients.