High visibility press for the Bioreference 4KScore Test

Prostate cancer is one of the great dilemmas in current medicine.  While prostate cancer is often derided in public policy as an oversampled, overtested, and overtreated disease, nonetheless, it accounts for an astoundingly large proportion of all cancer deaths in men.  This paradox is not discussed prominently enough.   While the largest scale studies show modest population benefits of PSA screening, the real lesson should be that if testing were 25-50% more accurate and therapies were 25-50% more effectively chosen, this issue would be converted from a marginal benefit into a heavily weighted "win" for precision medicine against one of the major killers in cancer.   PSA and its historical performance curve should not be taken as a given, especially in an era of rapidly evolving diagnostics.  Replacing PSA should be taken as a mandate, as an urgent public health issue.  It would be like fixing a play by booting out a crappy actor and replacing him with a good one.

White Paper on Business Challenges for the Advanced LDT Industry

A couple years ago, a friend who works in venture capital asked me, "What are the main hurdles to success for a startup molecular lab?"   This topic is timely given the new burst of enthusiasm and venture funding flowing into LDT and usually Next Gen molecular diagnostics in 2H2015 and early 2016.  Liquid biopsy oncogene panel tests are rising rapidly in prominence and fall into the LDT category for the foreseeable future.

One of the easiest entry points to the topic was writing a white paper on some of the key barriers that are poorly understood outside the field, such as the challenges of a new lab being "out of network" with the health plans of the patients it provides tests for.   This and other distinct business challenges are explained in my white paper, "Evolving Challenges for Value Priced LDTs."

While the body of the white paper remains as written in 2014, the topics are timely.  For example, out of network labs were covered in Dark Daily in December 2015 (here).  However, 2015 topics like PAMA are not covered in this white paper.

The white paper is archived in the cloud and can be downloaded, here.

Is the "70% Rule" for Impact of Lab Tests an Urban Myth???

• For update that actually HAS a 70% data source, see here.

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For years we have heard that "70% of clinical decisions rely on lab tests."  While there is no question that lab tests are very often pivotal to a patient's management, a few years ago Mike Hallworth published a two page article that decimates the evidence base for this quotation.

Hallworth is a clinical biochemist in England; his 2011 paper is open access at Annals of Clinical Biochemistry, here.

MolDX Redesigns Its Website!

For the new year 2016, MolDX launched a complete and modern redesign of its website.  It features a new homepage with a ready list of popular topics.   It also includes a banner, that uses the top of the screen of all topic sections, and allows "one click" return to the "MolDX Hub."

You'll love it.  Here:  (click).

http://www.palmettogba.com/palmetto/moldx.nsf/DocsCatHome/MolDx

Don't forget to like MolDX on Facebook and follow it on Twitter - !

Big Data at JP Morgan (Panel)

At the January 2016 JP Morgan biotech conference, Astellas and Deloitte sponsored an expert panel on where we stand with big data in the life sciences, and where we should be by 2025.   A brief summary is provided, along with a link to more detailed notes.

January 2016: 34th Annual JP Morgan Healthcare Conference

This week, hotels all over San Francisco are sold out as the biopharma, medtech, and investment worlds converge on the JP Morgan Healthcare Conference in San Francisco.   Admission to the halls of the event itself is limited to C-level executives and to credentialed investors.  However, the hotels and restaurants are filled to the rafters with countless additional executives, as well as thousands of attorneys, consultants, and others.  

The conference website is not secret and conference materials are generally posted in the interests of open SEC disclosure of investment information to the public.  While that being true, the public website entrance can be a little bit tricky to call up on Google, it is here;   http://jpmorgan.metameetings.com/confbook/healthcare16/login.php  (here).

FDA Posts Transcripts of November 2016 Next Gen Sequencing Workshops

On November 12, 2015, the FDA held a workshop on analytical performance for next generation sequencing tests.  On the next day, November 13, the FDA followed with a workshop on the use of public databases as reference standards "the clinical relevance of genetic variants."  The FDA has now published transcripts of both conferences.   (Other materials, such as agendas, webcasts, and Powerpoints, are also online at the FDA.)

Medicare Says: Don't Bill Single Gene Codes along with Tumor Gene Panel Codes

Since 1996 Medicare has published "procedure to procedure" edits, which are large excel spreadsheets showing which codes should not be used together, because they are exclusive or because one is encompassed by the other.  For 1/1/2016, Medicare has block used of single gene (and "Tier 2") genomic codes if tumor gene panel codes are used on the same claim.