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23andMe DNA Test Highlight: Its Cancer Home Test is FDA-Approved!

Testing for cancer gene markers was expensive and almost impossible until a few years ago. The development of the direct-to-consumer (DTC) test kit— like the 23andMe DNA Test —to screen for possible breast cancer has now allowed more people to undergo the test without the need to go to a clinic. The test is unobtrusive and noninvasive. It could be done in the privacy of the home or even on any desk. Patients mail their samples for testing and the results are sent back shortly. These tests are especially helpful for people who have a family history of breast cancer.

The good news is that the Food and Drug Administration (FDA) has approved the screening test for BRCA1 and BRCA2 genes. After almost 5 years, authorization was finally granted the 23andMe DNA test (specifically, the test for cancer testing at home) for marketing.

In Detail: 23andme

In 2013, the FDA even issued a cease and desist order against the company for marketing tests for hereditary disorders. The strongly-worded letter was addressed to CEO Ann Wojcicki—who bravely continued the good work they were doing even with all the challenges and hurdles they encountered. The company was recently vindicated with the approval not just for the BRCA 1 and 2 tests, but also for a whole range of Personal Genome Service Genetic Health Risk (GHR) tests. This said 23andMe DNA test covers Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, Gaucher disease type 1, glucose-6-phosphate dehydrogenase deficiency, hereditary hemochromatosis and hereditary thrombophilia.

Breast Cancer Detection Made Easy

The Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2) gene mutations are significant indicators of possible breast cancer in women and prostate or breast cancer in men. It is emphasized that the majority of women who get breast cancer have no family history of the disease. The 23andMe DNA test for cancer screening is only applicable to those with a history of breast cancer in the family. The test itself uses a blood sample, not a tissue sample. This detail makes it an easier test and definitely more comfortable for the test subject.

The BRCA1 and BRCA2 genes  are abnormal genes which can be inherited from either of the parents. Only about 5 percent to 10 percent of all incidents of breast cancer patients in the United States have abnormal genes. However, those who do have the mutated gene have a higher risk of up to 60 percent to be diagnosed with breast cancer. In contrast, 12 percent to 15 percent of women overall are diagnosed with breast cancer. It should also be noted that other types of gene abnormalities have less probability of leading to cancer.

Other Details on DTC tests Like the 23andMe DNA Test

The existence of DTC testing (like that of the 23andMe DNA test) has become a trend—which started last year—that is expected to grow even more. In fact, there were more than 12 million tests conducted last year, according to industry estimates. This sudden boom, which resulted from the aggressive competition in the industry, also brought prices down significantly.

Improvements in results and significant price drops mean that genetic screening is now more accessible to the common consumer. This case means that more people can gain access to genetic screening, which can alert them on whether or not they have a genetic predisposition to get cancer later in life. Undoubtedly, the industry hopes to detect the early onset of cancer or even stop the development of cancer entirely for those who are at risk.

At Risk

There are other conditions to be considered prior to testing. There is little chance of BRCA1 or BRCA2 mutation if there is only a single family member who has had breast cancer that occurred when she was 45 years old or older. In fact, those  are recommended for testing for the abnormal genes are the following:

  • Has a family member with BRCA1 or BRCA2, or other inherited gene mutation which is linked to breast cancer.
  • Has had a prior history of breast cancer at 45 years old or younger.
  • A personal history of breast cancer, as well as a family member from a parent, sibling, child, grandparent, grandchild, uncle, aunt, niece, nephew or a first cousin, with breast cancer at age 50 years old or younger.
  • A personal history of breast cancer and with 2 or more family members who have had breast, pancreatic, or aggressive prostate cancer.
  • A person of Ashkenazi Jewish lineage and a history of a breast of pancreatic cancer.
  • A personal history of estrogen receptor-negative, progesterone receptor-negative and HER2-negative breast cancer and diagnosed at the age of 60 years old or younger.
  • A personal or family history of ovarian cancer.
  • A personal or family history of male breast cancer

To Screen or Not to Screen

If there is a low chance of finding the abnormal genes, specifically, if the candidate does not fit the above profile, there is no need to screen for the BRCA1 or BRCA2 mutation or use tests such as the 23andMe DNA test.

There are more than a thousand mutations for the BRCA genes. Of these, only three mutations are linked to breast cancer development. The tests, like the 23andMe DNA Test, do not detect the mutations which do not lead to cancer. Having even one of these mutations result in women having significantly bigger risks of developing ovarian and breast cancer later in life. For men who have any of the said three gene mutations, they can also develop breast and prostate cancer. The Ashkenazi Jews, as a group, have a significant chance of having a BRCA1 or BRCA2 mutation. However, people from other ethnic groups can also have the mutation, even if it is a considerably lower chance.

 23andMe DNA Test & Other Players in the Field

Kalorama Information recently projected growth in the DTC laboratory testing niche to hit over $350 million in value by the year 2020. This case accounts for a massive increase in consumers who are more educated and proactive about their health. There also has been a steady increase in the number of companies providing DTC lab testing options.

Aside from 23andMe (and its offering of 23andMe DNA Test), other key players include Color Genomics which sell color kits to help users identify if they’re at risk of developing ovarian and breast cancer.

  • Gene by Gene is a Houston-based company which offers a wide range of genetic tests.
  • MapMyGenome, based in India, screens for genetic traits, drug response, and inherited diseases.
  • Pathway Genomics, based in San Diego, CA offers various diagnostic tests which include hereditary cancer and carrier screening.
  • WellnessFX from San Francisco, for its part, uses advanced blood testing to examine biomarkers that cover cardiovascular, metabolic, hormonal and even nutritional health issues.
  • Helix, another key player in the industry, recently raised $200 million to increase its visibility in the market. The company creates DNA Passports where people can discover and learn information from their DNA.

In the Future of DTC Tests

The availability of direct-to-consumer tests has a significant and bold impact on the lives of millions of people. Those who are predisposed or candidates for cancer because of their family history can take the test on their own and not live anxiously with the possibility of developing the disease.

While this isn’t a direct cure for cancer or other degenerative diseases, prevention and early detection still make a big difference. Having the power to take the test anytime a person wishes to gives that person some sort of control over his health and future.

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Can Blockchain Cure Prior Authorization Woes?

Although it is one of the of the most technologically-rich industries on the planet, the healthcare industry still suffers from simple inefficiencies caused by antiquated human-to-human communication. While HIPAA-compliant infrastructures drive state-of-the-art patient care, faxed paperwork and phone-based dialogues still drive many of the interactions between departments and organizations. This is where blockchain comes into potential to solve prior authorization approvals.

As a result, vital pre-authorization approvals for medical procedures or life and death collaboration between different practitioners can take too long and live outside the transformative EHR systems that drive the industry.

Can Medscient Cure Prior Authorization Approval Process?

A Florida-based company is trying to change all of that by leveraging the growing popularity of distributed ledger technologies (i.e. blockchain) to bring increased speed, faster data integration, and more robust stability to the peer-to-peer communication channels that drive today’s healthcare industry.  Medscient LLC produces a HIPAA-compliant, healthcare-only blockchain framework designed to streamline human or machine interface issues for life and health insurers.

The key to the technology is that it provides both insurers and care providers with a common data set of patient information on a distributed ledger, where it can be securely shared by all parties, explained Vince Albanese, CEO of Medscient. The data is used to create smart contracts, which become the rules used to automatically make pre-authorization decisions.

Impact of Blockchain on the Medical Society of Delaware

Medscient is currently working with Medical Society of Delaware (MSD), the Delaware Health Information Network (DHIN), Global Delaware and the state’s health insurers to integrate agnostically with leading blockchain frameworks like MultiChain, Hyperledger and to create greater transparency, trust, and accountability between typically untrusting parties.

According to Dr. Andrew Dahlke, MSD Vice President, “This is a truly exciting project. The distributed ledger is a transformative technology that offers a definitive solution to the problem of pre-authorization that can benefit all parties—patients, doctors, nurses, hospitals and insurers.”

Together with the Medical Society of Delaware (MSD), Medscient has presented a Proof of Concept (POC) for their solution at the Medicaid Enterprise Systems Conference in Baltimore.  This POC illustrates how the company actively mitigates the cost, risk, aggravation and safety issues related to steps and execution of prior authorization, reducing delays by days and showed the potential opportunity to decrease overall costs between insurers and healthcare providers to the tune of $20 billion each year.

Prior Authorization Answers a Need

Prior authorization is used in the industry to obtain additional patient information from the healthcare provider, the prescriber of a procedure, service or medication. The aim of the process is to ensure eligibility of the patient, assess the benefit coverage, medical necessity, location and the appropriate use of the services.

Blockchain company Medscient is curing prior authorization issues
Can Blockchain solve prior authorization

“Essentially, we are negotiating the ‘metrics of trust’ between the parties,” Albanese explains. “We are coding agreed-upon rules of pre-authorization in smart contracts that will, in turn, execute decisions that all parties can agree are appropriate and correct.” The solution will provide automated prior authorization decisions more quickly, consistently and objectively, he noted.

Blockchain Impact to Information Gathering

Medscient is impacting information gathering where it is currently hitting a major snag. Communication between repositories of patient data (PHI) are frequently paper-based and their system incongruent with each other in terms of content. Data resides in a vast, elaborate network of disparate EHR databases located on a myriad of corporate servers behind a multitude of firewalls.

The lack of trust across the system prevents the different participating companies from creating a seamless connection between systems, or from using centralized cloud-based storage of PHI that would allow authorized and trusted stakeholders from access needed information from common repositories.

Distributed ledger technology provides a perfect peer-to-peer solution to address these problems, but to date, proprietary blockchains and a lack of perceived security in the Wild West cryptocurrency marketplace have cast a negative shadow on the power of these agile technologies.

While the healthcare industry has, and is, aggressively pursuing practical applications for blockchain technologies, with the growing hype and perceived risks associated with blockchain reliant cryptocurrencies like Bitcoin, Ethereum, and Verge; as well as the nearly weekly ICO’s from overly aggressive upstarts, the adoption has been slow, meticulous and heavily scrutinized.

Secure Data Accessible to All

Medscient focuses on utilizing the blockchain only for “trust indicators” or data elements specifically designed to enable commerce between typically untrusting parties. Valuable or protected source data remains where it is with the blockchain holding pointers, scores or indicators. Medscient’s system hosts no private data external from its stakeholders. In addition, Medscient supports the Institute for Healthcare Improvement’s (IHI) Triple Aim Measures. This ensures that the use of blockchain will not equate to reduced security or instability.

The application of blockchain in targeted population health, patient experience, and cost-related opportunities is the very best place to help healthcare providers, insurers and their members. By providing an agnostic framework that works on any blockchain, Medscient is able to provide secure and seamless integration with the many disparate systems and proprietary databases that currently make up the healthcare marketplace. Medscient ties together the healthcare ecosystem by leveraging open standards and not choosing one blockchain technology over another but instead focusing on the commonalities that each offers the industry.

In a $3.4 trillion healthcare industry, with an estimated $190 billion in administrative waste, even a very modest reduction in wasted time and resources can result in billions of dollars in savings. More importantly, such a system in the future could lay the groundwork for faster access to healthcare records across a wide range of sources, hospital networks, pharmaceutical companies, clinics, and a wide variety of health care providers. As a result, patients win with lower prices and a more secure way to protect their PHI. This is a Bold Idea that has the potential to make a broad impact on the healthcare industry.

Natural Growth of Cannabis will Surpass the Alcohol Industry Cartoon

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The alcohol-marijuana connection is something to be leveraged by business owners. There’s no doubt; it will be a big market worldwide.