Easy, in-office web space procedure with fast PCR results

While interdigital infectious dermatitis may be due to a variety of organisms that cause similar presentations, we know their treatment differs.

BakoDx developed a highly sensitive and highly specific PCR test to identify the exact infectious agents involved in web space dermatitis. The simple skin scrape test is performed in-office, providing podiatric clinicians with ease of use, rapid results and the most accurate diagnostic method available – allowing for optimal patient satisfaction.

The BakoDx Web Space PCR assay identifies the fungal and/or bacterial causative agent within the web space keratin, when present, resulting in the clinically identified dermatitis.

• Dermatophytes
• Candida spp
• Corynebacterium minutissimum
• Pseudomonas aeruginosa
• Staphylococcus aureus*

*If positive, reflex test is performed for the mecA gene of methicillin-resistant Staphylococcus aureus (MRSA).

“This test is designed for those patients with web space dermatitis, where an infectious etiology may be included in the differential diagnosis,” said Dr. Wayne L. Bakotic, Chief Medical Officer at BakoDx. “PCR analysis allows us to identify the infectious agent in the most accurate, efficient and rapid manner.”

Differential diagnosis for interdigital dermatitis may include Corynebacterium minutissimum in erythrasma, tinea pedis, candidal intertrigo and/or primary or secondary bacterial infections. There is also a growing awareness of gram-negative bacterial web space infections. The differential diagnosis of web space dermatitis would also include non-infectious etiologies such as web space eczema or psoriasis.[1]^,[2]

The BakoDx Web Space panel identifies the causative agent of interdigital skin infections with the highest sensitivity and specificity available, compared to conventional diagnostic methods. Results are available within 1-2 days, giving clinicians the advantage of rapid, targeted patient treatment plans. The comprehensive molecular analysis report provides a clear and detailed explanation of the test results and therapeutic options, with literary references.

^{[1] Hainer BL. Dermatophyte infections. Am Fam Physician. 2003; 67(1):101-8.
[2] Bristow I. Non-ulcerative skin pathologies of the diabetic foot. Diabetes Metab Res Rev. 2008;24(Suppl1):S84-89.}

^{[1] Internal validation study with clinical samples, ranges based on entire panel of target organisms. [2] J Am Acad Dermatol. 2003 Aug;49(2):193-7. [3] Jacob Oren Levitt, Barrie H. Levitt, Arash Akhavan, and Howard Yanofsky, “The Sensitivity and Specificity of Potassium Hydroxide Smear and Fungal Culture Relative to Clinical Assessment in the Evaluation of Tinea Pedis: A Pooled Analysis,” Dermatology Research and Practice, vol. 2010, Article ID 764843, 8 pages, 2010; Journal of Basic & Clinical Medicine 2016; 5(2):4-6}

“The identification of pathogens present in web space infections is critically important for prompt and effective therapy,” said Dr. William P. Scherer, Senior Podiatric Medical Advisor for BakoDx. “Providing the appropriate therapy reduces treatment failures and repeat patient visits. In addition, early and accurate diagnosis may also prevent secondary infections compounding the clinical presentation and adding complexity to the treatment regimen.”

While a skin biopsy is recommended for a histopathologic evaluation when neoplastic processes and non-infectious dermatitis are suspected, the web space PCR test is intended to be the first line diagnostic option for patients with superficial web space dermatitis to diagnose or rule out infectious etiologies.

LESS INVASIVE SKIN SCRAPE SAMPLE COLLECTION

The collection method for a patient’s specimen is a superficial skin scraping performed in-office with the debris collected in a Dermapak®.

When it comes to proper web space specimen collection technique and obtaining adequate tissue, Dr. Scherer states, “the best method is to scrape exfoliated surface keratin directly into the Dermapak®, followed by wiping the instrument on the inner surface of the collection pack to ensure optimal acquisition. If visible tissue is procured from the scraping, then you likely have adequate sample for testing.”

This collection method is time saving and by far a less invasive sampling method with little to no post procedure wound care.

“With the definitive identification of the infectious agent through the use of PCR testing, physicians can rest assured their first therapeutic choice is the best option,” said Dr. Bakotic.

To begin ordering the BakoDx’s Web Space PCR test as the first option in your patient care algorithm for patients with suspected infectious dermatitis, call 855-422-5628 or visit bakodx.com/webspace.

^{[1] Internal validation study with clinical samples, ranges based on entire panel of target organisms.}

^{[1] J Am Acad Dermatol. 2003 Aug;49(2):193-7.}

^{[1] Jacob Oren Levitt, Barrie H. Levitt, Arash Akhavan, and Howard Yanofsky, “The Sensitivity and Specificity of Potassium Hydroxide Smear and Fungal Culture Relative to Clinical Assessment in the Evaluation of Tinea Pedis: A Pooled Analysis,” Dermatology Research and Practice, vol. 2010, Article ID 764843, 8 pages, 2010; Journal of Basic & Clinical Medicine 2016; 5(2):4-6}

The Bako Medical Education Foundation (BMEF), a non-profit organization that seeks to advance diagnostic excellence in the field of podiatry, announced today that it has completed the funding of endowed scholarship commitments to each of four podiatric medical colleges.

BMEF receives funding from BakoDx.

The Barry University School of Podiatric Medicine, Dr. William M. Scholl College of Podiatric Medicine at Rosalind Franklin University of Medicine and Science, New York College of Podiatric Medicine and Western University of Health Sciences College of Podiatric Medicine each received endowed scholarships of $100,000, which were funded to the schools in annual installments over the past four years.

The scholarship funds provide financial assistance and recognition to top students enrolled and/or accepted at the colleges.

“BMEF sponsors institutions that seek to train the podiatric medical community on innovations and best-practices in medical diagnostics,” said Sue MacCormack, Chair of the Bako Medical Education Foundation. “By funding educational opportunities, BMEF hopes to empower the doctors of tomorrow with the knowledge and diagnostic expertise they will need to improve outcomes for patients. We are humbled to play a part in supporting the education eco-system that will enable today’s medical students to succeed in the future.”

For more information, visit www.bmef.org.

ATLANTA — Bako Diagnostics has expanded its molecular test portfolio to meet the U.S. need for the novel coronavirus testing, with results completed in 24 hours. The BakoDx SARS-CoV-2 RNA (COVID-19) test meets Centers for Disease Control and Prevention guidelines and will be offered under the U.S. Food and Drug Administration’s Emergency Use Authorization.

The diagnostic laboratory, based in Alpharetta, Ga., began molecular testing for COVID-19 on April 6. BakoDx is able to perform more than 2,000 tests per day, with plans to increase that capacity.

“Our development team has been working diligently to make COVID-19 testing more widely available and with 24 hour turnaround time for results,” said Ted Hull, CEO of BakoDx.

The BakoDx SARS-CoV-2 RNA test was developed based on years of molecular experience and under CDC guidelines. The real-time polymerase chain reaction (RT-PCR) test has been validated to identify the virus from samples collected via nasal, nasopharyngeal, and oropharyngeal swabs.

“Utilizing nasal swabs to collect potential COVID-19 specimens will allow healthcare providers to oversee a patient collecting their own sample, while preserving personal protective equipment that has seen a major shortage across the country,” said Dr. Wayne L. Bakotic, Chief Medical Officer and co-founder of BakoDx.

Healthcare centers with need for additional COVID-19 testing capacity are asked to contact the lab through its website – bakodx.com.

BakoDx is a biosafety level 2 lab and follows strict personal and environmental hygiene protocols, which have been further strengthened and reinforced with all employees since the early days of the COVID-19 outbreak.

Specimens for COVID-19 testing are not collected at the lab. For anyone who believes they may have contracted the virus, BakoDx urges them to seek medical advice to determine if testing is appropriate.

“We will work closely with state health officials and healthcare facilities needing additional testing for COVID-19, and increase test capacity in response to this public health crisis,” Hull said. “We understand the importance our lab plays in the safety of the public, patients, healthcare providers and our employees.”

If you are a clinician, please call 1-855-422-5628 or visit bakodx.com for more information.

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CLINICAL STUDY

DNA-based detection for onychomycosis correlates better to
histopathology than does fungal culture

BakoDx has served the podiatric medical community for the past 10 years and has shown a deep dedication and passion for the profession. It is an honor, privilege, and pleasure for the APMAPAC Board to recognize BakoDx as its first APMAPAC Champion of 2019.

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ATLANTA — Bako Diagnostics is pleased to announce that Tracey C. Vlahovic, DPM, has joined its Podiatric Medical Advisory Board. Dr. Vlahovic is a Clinical Professor and J. Stanley and Pearl Landau Faculty Fellow at the Temple University School of Podiatric Medicine (TUSPM) in Philadelphia. She is also a member of the Faculty of Podiatric Medicine of the Royal College of Physicians and Surgeons (Glasgow).

The Bako Diagnostics Podiatric Medical Advisory Board is made up of a group of talented leaders, who support the podiatric medical and surgical community through education, innovation and research. “Dr. Vlahovic’s experience, knowledge and expertise will be a great addition to the Advisory Board and help drive our commitment to the podiatric medical community,” said Dr. Wayne L. Bakotic, Director for the Advisory Board.

After graduating from Yale University with a Bachelor of Science in Molecular Biophysics and Biochemistry, Dr. Vlahovic received her podiatric medical degree from TUSPM. She completed her surgical residency at St. Luke’s University Health Network, and became the first podiatrist in the U.S. to complete a fellowship in podiatric dermatology. Dr. Vlahovic currently teaches Fundamentals of Dermatology at TUSPM and is board certified in foot surgery by the American Board of Podiatric Surgery.

She is the co-author of “Skin Disease of the Lower Extremities: A Photographic Guide (HMP Communications)” and “Onychomycosis: An Illustrated Guide to Diagnosis and Treatment.” Dr. Vlahovic has also authored articles in peer-reviewed journals and is involved in clinical research trials for dermatological therapies and devices.

Current members of the Bako Diagnostics Podiatric Medical Advisory Board include Dr. Wayne L. Bakotic, Dr. Allen M. Jacobs, Dr. Jeffrey D. Lehrman and Dr. William P. Scherer. “I couldn’t be more excited to join this team, whose aim is to advance the podiatric medical profession,” said Dr. Vlahovic.

To view all of Bako Diagnostics Medical Advisory Board members, please click here.

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Dr. Naghmeh Lilly Khavari

ATLANTA — Feb. 7, 2019 — BakoDx is pleased to welcome Dr. Naghmeh Lilly Khavari to its Clinical Consultant Team. Dr. Khavari is a board certified, surgically-trained foot and ankle specialist focusing on pediatric and diabetic foot care, sports injuries, as well as acute and chronic conditions of the foot and ankle. She is a physician-owner of Carrollton Foot Center in Carrollton, Texas.

Dr. Khavari completed her Bachelor of Science degree in Biology at the University of Texas at Dallas. She then attended Barry University School of Podiatric medicine in Miami, Fla. At Michigan Surgical Hospital in Warren, Mich., Dr. Khavari completed three years of extensive surgical training in foot and ankle surgery and served as chief resident at the Kern Medical residency program.

“Dr. Khavari is a very well-respected podiatric clinician and accomplished speaker,” said Shawna Shapero, BakoDx’s Vice President of Corporate and Professional Relations. “Her early training at Michigan Surgical Hospital has served as a cornerstone for her perseverance as a podiatric educator and as an advocate for the podiatric medical community. I am certain that her perspectives will serve to fortify our educational outreach.”

Dr. Khavari is a Fellow at the American College of Foot & Ankle Orthopedics & Medicine and a member of the American Podiatric Medical Association, Texas Podiatric Medical Association, American Academy of Podiatric Practice Management, American Association for Women Podiatrists and the Institute for Podiatric Excellence and Development.

Her training includes pediatric foot care, wound prevention and wound care, diabetic limb preservation, as well as surgical and non-surgical treatment of foot and ankle conditions, sports medicine, trauma management, and reconstruction of complex foot and ankle deformities. Her areas of interest include pediatrics, forefoot surgical correction, wound care, as well as sports medicine.

To view all of Bako Diagnostics clinical consultant team members, please click here.

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ATLANTA — Jan. 24, 2019 — Bako Diagnostics continues its strong in-network laboratory status with all five national health plans into 2019.

Members covered will continue to have access to Bako Diagnostics’ routine and patented testing, including anatomic pathology, clinical pathology, proprietary DNA testing, microbiology and neuropathy-related test offerings.

“While national payors continuously monitor their laboratory network needs, Bako Diagnostics is proud of our continued contractual relationships with all five national health plans,” said Diana Brandon, Vice President, Strategic Development and Payor Relations at Bako Diagnostics.

Bako Diagnostics’ in-network services are available to more than 250 million covered lives, including all five national health plans and fully compliant patient-friendly billing policies.

For a list of all insurances accepted by Bako Diagnostics, please visit http://bit.ly/2ChO6Mh

DISCLAIMER: Bako Diagnostics is not part of certain capitated networks.

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