News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

UCSF Genomics Diagnostics Team Uses Next-Gen Sequencing as a ‘Laboratory-Developed Test’ to Reveal an Elusive Pathogen’s DNA and Save a Teen’s Life

It took UCSF physicians just 48 hours to identify the bacteria in cerebrospinal fluid that was causing fourteen-year-old Joshua Osborn’s hydrocephalus and status epilepticus

There’s rich irony in the FDA’s  recent announcement that it would move forward with plans to regulate “laboratory-developed tests ” (LDTs) just weeks after the national media published stories about how innovative use of an LDT helped physicians make an accurate diagnosis that saved the life of seriously-ill 14-year old boy.

Pathologists and clinical laboratory managers may be aware of the case of Joshua Osborn. It was a laboratory-developed test that used next-generation gene sequencing in a unique approach that gave his care team the diagnostic information they needed to select the right therapies for his condition.
(more…)

MIT Researchers Detect Cancer from Urine Specimens by Combining Synthetic Biomarkers with Paper-based Diagnostics

Pathologists and clinical laboratory managers may soon see this innovative combination of diagnostic technologies used in developing nations

There is now a technology that combines synthetic biomarkers with a paper-based urine test that can detect colorectal cancer and thrombosis in just a few minutes. Medical laboratory tests incorporating this diagnostic technology would be accurate, cheap, and simple enough to perform in developing countries.

Researchers at Massachusetts Institute of Technology (MIT) say that the new technology opens the door to development a cheap diagnostic tool for a range of noncommunicable diseases (NCD). This could revolutionize diagnostic testing of NCDs, with particular significance for developing countries. (more…)

Illumina Asserts Its Claim of a $1,000 Whole Human Genome, But Is Gene Sequencing Ready for Use by Clinical Pathology Laboratories?

This price includes all costs except overhead, but without a high volume of customers, Illumina’s $10-million price for the HiSeq X Ten machine may not be a wise investment

Competition continues to be fierce in the race to the $1,000 whole human genome. Most recently, Illumina announced the availability of its latest gene sequencing system, along with the claim that it can deliver a whole human genome at a cost of just $1,000. But, as most pathologists know, the devil is in the details, since not every Illumina customer is likely to achieve that price point.

When Illumina, a San Diego-based technology company, announced its new HiSeq X Ten genetic-sequencing machine in December, 2013, Illumina CEO Jay T. Flatley claimed the company’s system can deliver “full-coverage human genome sequences for less than $1,000,” down from $500 million 10 years ago. The new system is expected to ship in the first quarter of 2014.

(more…)

23andMe and Udacity Launch ‘Massive Online Open Course’ in Human Genetics

Innovative web-based educational formats might add value to training initiatives for pathology residents and fellows and medical laboratory workers

In the final months of 2013, the regulatory fight between gene testing company 23andMe.com and the Food and Drug Administration (FDA) generated national headlines. In that encounter, 23andMe.com blinked and ceased offering health-related genetic tests to consumers.

However, the company continues to work to position itself as a major player in genetic testing and genetic medicine. In the second half of 2013, for example, 23andMe.com initiated a business campaign to position itself as a source of on-line information about genetics for educational purposes. (more…)

In Its Second Year, Medical Home Program of CareFirst BCBS Produced $98 Million in Savings, along with Significant Quality Improvements

In Its Second Year, Medical Home Program of CareFirst BCBS Produced $98 Million in Savings, along with Significant Quality Improvements

One of the nation’s largest patient-centered medical home  (PCMH) programs has reduced costs dramatically and improved care quality for the second consecutive year. It recently reported the achievements produced during its first two years of operation.

This accomplishment is more evidence for pathologists and clinical laboratory executives that a properly implemented medical home program can deliver measurable gains in patient outcomes and corresponding reductions in the overall cost of care. In January 2011, CareFirst BlueCross BlueShield started a PCMH program for primary-care physicians (PCPs). It serves about 1 million members in Maryland, Washington, D.C., and northern Virginia.
(more…)

;