Offering New Hope for Patients Suffering From Challenging Infections
MicroGenDX specializes in low-cost, highly accurate qPCR + NGS microbial DNA diagnostics — providing answers where cultures or PCR alone have failed.
Rick can speak on the following topics:
- Hope for patients with chronic life altering infections
- Clinical diagnostics for microbial infections
- Clinical research studies
- Chronic infections and their impact on patient’s lives
- Antibiotic stewardship and the dangers of overprescription
- Challenges of publishing research in peer-reviewed medical journals that challenges the status quo
- Challenges of changing industry behavior (Doctors, Hospitals, Medical Journals, Health Insurance, Professional Medical Societies) around disruptive technologies
- Strategies for gaining industry adoption of innovative technologies
- Entrepreneurship and effective leadership
- Building and growing a company in today’s challenging medical diagnostics market
Chief Executive Officer and owner of MicroGen Diagnostics
Chief Executive Officer and owner of MicroGen Diagnostics, a company at the forefront of using Next-Generation DNA Sequencing (NGS), to accurately identify the root causes of chronic infections.
Simply put, delaying the use of the molecular diagnostic testing tools we already have in hand until then would be tragic, because millions are suffering needlessly now, for the sake of what is an antiquated, if comfortable, status quo.
- Rick Martin presents the technology behind Next generation Sequencing (NGS) for accurately identifying bacteria and fungi in chronic infections.
- DNA analysis of bacteria and fungi
- The process might be thought of as genetic photocopying.
- Simply stated, NGS (Next Generation Sequencing) supplies a complete and exact analysis of the potential pathogens in a tissue sample through DNA analysis. It does so, according to the government body in charge of certifying labs, CLIA (Clinical Laboratory Improvement Amendments) with a 99.6% accuracy rate.
Richard “Rick” Martin is the Chief Executive Officer and owner of MicroGen Diagnostics, a company at the forefront of using Next-Generation DNA Sequencing (NGS), to accurately identify the root causes of chronic infections. MicroGen DX leverages its patented advanced NGS technology to aid individuals grappling with chronic or life-threatening infections by providing physicians with crucial information for developing effective treatment plans. Rick has also led industry research efforts by sponsoring over seventy studies published in peer- reviewed medical journals demonstrating improved patient outcomes when using NGS compared to traditional diagnostic methods.
In 2016, Rick took ownership of the laboratory, formerly known as Pathogenius, from its founder, Dr. Randy Wolcoti. He is commitied to realizing Dr. Wolcoti’s vision of making NGS technology widely available beyond university research settings. Before stepping into MicroGen DX, Rick held the position of CEO and founder at Apollo Healing Technologies.
- Rick’s expertise at Pfizer was centered around antibiotics. Before venturing into the medical industry, he dedicated 12 years to military service as an officer in the United States Army.
- A recognized authority in the field of advanced diagnostics, Rick frequently shares his knowledge as a guest lecturer on NGS for microbes at medical conferences.
- Retired, U.S. Military. His corps commander, Colin Powell.
- Recruited by the FBI.
With so much research data and clinical experience in NGS’s favor, why has it not been adopted as the new standard in care in any specialty? It would seem that its therapeutic utility, especially in cases of chronic infections or use-cases where the patient is at high-risk, has already been well established.
DNA testing may have been used for the last thirty years in criminology—and every Forensic Files and CSI episode—but the medical establishment has for years resisted adopting its diagnostic use for bacterial and fungal infections. Chronic infections afflict millions each year in the United States and kill untold numbers. Often the bacterial and fungal sources of these infections are misdiagnosed because of the medical establishment’s reliance on C&S—Culture and Sensitivities.
C&S has such a high failure rate across many areas of medicine, however, that doctors resort to what’s called the “empirical method” in prescribing antibiotics. Again, the “empirical method” boils down to making educated guesses. These guesses so often prove wrong that many strains of bacteria, both aerobic, anaerobic, and others termed “fastidious”—meaning they refuse to grow in the media, the broths, of traditional cultures—have become resistant to increasing types of antibiotics. They have evolved into “super bugs” whose susceptibility to even the most advanced antibiotics is rapidly diminishing.
The problem of chronic infections is not only a problem for its victims but everyone’s problem. An article in The Lancet reported that 1.2 million people died across 204 countries in 2019 from anti-microbial resistance (AMR)—people administered antibiotics that proved ineffective. The rate of death from AMR outpaced mortality from HIV/AIDS or malaria.
The suffering, the death, and the coming tsunami of infectious disease wiping out ever greater swaths of the population as our antibiotics prove useless are unnecessary. The key part of the solution—advanced diagnostics—exists. Accurate diagnosis of the bacteria and fungi that cause chronic and often deadly infections is available through MicroGen’s qPCR + NGS testing. So is the means to determine what antibiotics can be effective in the treatment of such infections and what antibiotics should be avoided. The technology’s essential nature, performing a DNA analysis, is something with which we are all familiar, too. It would seem that those concerned about “antibiotic stewardship” in the face of the AMR crisis would recognize NGS’s advantages in this regard.
Our questions included the following:
1. When traditional culture is negative and the patient still has clear signs and markers of infection, what is your company’s guidance to the treating physician? What is the basis for this guidance?
2. Given the failure rate of traditional testing to identify and treat many common recurring infections and the poor antibiotic stewardship this failure encourages has your company evaluated the role of testing accuracy in encouraging better antibiotic stewardship by physicians?
3. In making determinations of reimbursement policy for clinical lab testing, insurance experts frequently cite the need for outcome-based studies. Have those responsible for your policy considered the attached outcome-based studies? If these studies have yet to be considered by your policy committee, will they be reviewed and when?
4. While each insurer has a right to determine the scope of its coverage, are you aware that Medicare and Medicaid both cover MicroGenDX’s testing? Medicare granted MicroGenDX its own PLA code – 0112U in October of 2019. Under Medicare regulations, a basic requirement for finding a diagnostic test to be medically reasonable and necessary is that the treating physician has to order it to help manage the patient.
5. Finally, has your company ever conducted longitudinal cost/benefit analyses to determine the true cost of chronic infections such as UTI’s? The information I have been able to gather to date indicates that such policy decisions are made by panels of experts without reference to longitudinal data studies. Is this true?
To date Aetna, Cigna, and the central office of BlueCross/BlueShield have failed to respond. These major insurance companies’ refusal of coverage may be seen as a cost-saving measure. This “cost-saver” may backfire, however. Stonewalling won’t work forever.
When will the “promise for the future” of molecular testing finally arrive? And how?
Besides the formal objections of diagnostic confusion leading to poor antibiotic stewardship, there may be a darker aspect to the resistance this advanced diagnostic tool has encountered. There seems to be jockeying for position as to whom will reap its spoils. Who gets the credit and
who makes a fortune?
Dr. Nickel commented that in his 35 years of being a practicing urologist and urological researcher he’s never before seen the type of politics that is known to plague research into new drugs or medical devices. Research in these areas was like “a space race,” where fortunes and reputation hung in the balance. Now the same “space race” mentality has come to the fields of infectious disease and microbiology. “Next generation sequencing is going to be the new technology that will drive the field—not only discoveries in the field but day-to-day diagnoses. For both these reasons, academic careers will be made, and fortunes will be made as well. That’s what’s made the field so difficult for early investigators who want to be involved.”
While the medical establishment sorts its winner and losers, millions of patients suffer and see their lives fall apart. In the end one has to ask, for what?
Rick Martin’s MicroGenDX Plays David Against Goliath
In 2016, Robert Taylor, a police officer in the greater San Antonio area, began experiencing what’s politely termed “pelvic pain.” Pelvic pain includes sharp, stabbing, and burning feelings wrapped into a crushing grip of anguish. It’s like your pelvis is being squeezed to death by a boa constrictor while its stomach acids digest your genitals.
Describing the experience, Robert says that he went through “hell on earth.” It was much worse, he remarks, than the pain he once experienced when stabbed on duty.
Soon after the onset of the ailment, he couldn’t work or sleep.
He sought help immediately from a urologist. The doctor told Robert he probably had a case of CBP (Chronic Bacterial Prostatitis.) For unknown reasons, his infection had not first manifested as an acute infection, as most do, but had become chronic seemingly overnight. The symptoms of acute prostatitis usually abate as the infection becomes chronic. His had obviously not.
There was good news, though, as CBP is readily treatable. The doctor performed a rectal exam, took tissue samples, prescribed the standard antibiotics for CBP, and sent the specimens out for testing. He told Robert that he ought to feel much better in about ten days. In the meantime, he also prescribed pain medications.
Robert saw no improvement in ten days and received little relief from the pain medications. His physician reported that his test results came back negative or “within scope.” He would prescribe a broader-spectrum antibiotic. Why hadn’t the test results revealed anything? That often happened, the urologist admitted, even when there were clearly pathogens present. The testing had its limits. By prescribing a broader-spectrum antibiotic, his physician was resorting to the “empirical method.”
Since traditional cultures fail so often to provide any diagnostic information, physicians prescribe antibiotics that have worked in the past to cure patients with similar symptoms. The “empirical method” boils down to making educated guesses. These guesses are based on clinical experience, often many years of clinical practice, but are, nevertheless, guesses, since they are made in the absence of accurate information from testing.
As Robert’s condition continued, his life began to fall apart. It took all his mental and emotional resources simply to bear the suffering, and naturally, he became withdrawn and self-absorbed. He was fighting to hold onto his sanity. He tried a second urologist, then a third, then a fourth. Each performed the same rectal exam, wrote a prescription for one or more antibiotics, and assured him he ought to start feeling better soon.
This went on for two years. On his last visit to his fourth urologist, the doctor referred to the negative results of the testing. He was clearly frustrated and looked at Robert quizzically. Robert might want to seek assistance, he suggested, from a mental health provider, if only to improve his coping resources.
Worn out by his battle, Robert skipped the rage he would otherwise have felt and simply resolved never to see that “provider” again.
At his physical, emotional, and spiritual nadir, he broke down one night and confessed to his wife that he was thinking of killing himself. He could not live like this. He was nothing but a burden. He had been suffering now for a full two years.
Someone finally told him there was a Dr. Timothy Hlavinka, a urologist, whose waiting room included people from around the world. He seemed able to help people like Robert whose conditions only puzzled and frustrated other physicians.