Myriad Genetics (NASDAQ:MYGN) is a developer of diagnostic medical products, with a focus on cancer testing to help identify patients who are most at risk due to their genetics.

Diagnostics are perhaps not quite as sexy as the exciting rollercoaster ride that is drug development. But MYGN has some exciting things brewing in the pot. Today, I want to take a look with you regarding their recent performance, and then I want to share some thoughts on where their growing platform for prostate cancer assessment is going.

First, some financial considerations

The company's portfolio and ongoing development of therapies and diagnostic tools are supported by the successful launch and commercialization of its hereditary cancer platform.

In fact, according to the latest quarterly filings from the company, this suite of products brought in $140 million in Q1 2017. Overall, the company remains in the black with operating income of roughly $13 million in the first quarter.

While it's not bad to be in the black, this is a further decline in total net income from the same period in 2016, which saw over $40 million in net operating income. This is due in large part to an ever-expanding field of competitors in the diagnostic space.

Thus, MYGN needs to have success in other areas if they are to continue growing. And its field of cancer-specific diagnostic tests seems to be an important area of growth for the company.

Myriad bringing it in force at the Urologic Meeting

To date, MYGN's Prolaris platform, which helps to assess risk of relapse in men with prostate cancer, has not fundamentally changed the bottom line for the company. Since its launch in 2010, Prolaris revenue now stands on the order of millions of dollars per quarter, with the most recent filing showing $3.4 million in sales for Q1 2017.

Compare that to Genomic Health's Oncotype DX, which raked in over $10 million in Q1 2016, for something approaching a similar comparison.

The feasibility of growing the Prolaris numbers hinges on being able to firmly establish a benefit for the test. As such, it is with much gusto that MYGN has announced four studies being presented at the American Urological Association 2017 meeting.

They include the following abstracts:

Let's consider each of these, one by one:

Evaluating the Prognostic Utility of the CCP Score for Predicting Prostate Cancer Aggressiveness in African American Men

While Prolaris has shown benefit for predicting prostate cancer outcomes in a number of settings, there's not much information specifically relating to outcomes for African American men. Thus, MYGN undertook a more focused analysis to confirm the utility in this minority population.

The study looked at a cohort of 694 men, 38% of whom were African American. It showed that the Prolaris score distribution did not differ significantly based on race. Furthermore, whereas race did not accurately predict the risk of the development of metastasis, the Prolaris score did in a multivariate analysis.

This suggests that the use of Prolaris can help make more informed decisions without relying on clinicopathologic information.

Prognostic Utility of Biopsy-Derived Cell Cycle Progression Score in Patients with NCCN Low-Risk Prostate Cancer Undergoing Radical Prostatectomy: Implications for Treatment

Information regarding the prognostic value of Prolaris in low-risk disease is also sparse, so MYGN looked at patients who met the national guideline classification for low-risk disease to see the risk of biochemical relapse, as stratified by Prolaris scoring criteria.

Interestingly, three risk groups according to Prolaris results (low, intermediate, high) had five-year BCR-free survival of 89.2%, 80.4%, and 64.7%, respectively, representing a significant predictive power.

These findings suggest that the Prolaris test can provide substantial fine-tuning of the risk classification for patients with prostate cancer who are defined as low risk. It remains to be seen, of course, how doctors would make use of these results, but it will be interesting to see later how predicting the risk of biochemical relapse translates into overall outcome for these patients.

The Impact of Clinical CCP Testing in Men with Localized Prostate Cancer for Expanding the Population of Men Eligible for Active Surveillance

"Active surveillance," the treatment strategy of "wait as long as you can before treating" can be very effective for helping men with prostate cancer avoid treatment-related toxicity while maintaining disease control. However, it is tricky to accurately point out which patients should take this approach.

In this study, samples from over 17,000 men were analyzed and correlated with outcome, defining a population who can forego treatment based on Prolaris score.

The most interesting finding in the study was that a certain proportion of patients who would be classified as "high risk" based on clinical variables had a low enough score that they would be candidates for active surveillance. In the "AUA" high-risk group, 14.1% of men would be good candidates.

This is important for helping to preserve patient quality of life and cost of treatment. If you can safely forego therapy for some extended period of time, that's less treatment burden on the patient. So this could prove to be a useful tool as it gains more validation.

Patient NCCN Risk Classification Based on Combined Clinical Cell Cycle Risk Score

In case it hasn't become clear, using clinical variables (such as Gleason score and NCCN risk criteria) can be a pretty blunt way to assess risk of treatment failure. One of the big goals of molecular diagnostics in numerous fields of treatment is to develop cleaner tools for analysis, especially in these tumors where patients can often expect to live for decades after diagnosis.

In this study, clinicopathologic features were measured against the Prolaris score to assess the risk of death by ten years post diagnosis. A large portion of men in the traditional risk subgroups were reclassified. For example, 25% of the "low-risk" cohort were actually in higher risk of relapse. 47% of those in the "intermediate-risk" population were reclassified, as well.

What this tells us is that, for a strong minority of patients, clinical features alone will give misleading information to doctors as they attempt to formulate an effective treatment plan. Incorporation of Prolaris score into the process can help fine-tune the stratification of risk. While the conclusions for treatment selection are not quite clear, the implication is that doctors will be able to use this information in the future when selecting treatment.

For example, if you're clinically low risk, but your Prolaris score says you might be at higher risk, then the doctor could select a more aggressive treatment strategy for you.

Conclusions

The studies presented at AUA 2017 add more fuel to the engine that MYGN is building up. It remains to be seen whether this will affect uptake of the Prolaris platform in the clinic, but with over 160,000 diagnoses of prostate cancer in the US alone, there is a deep potential market for this diagnostic platform.

If MYGN can continue to demonstrate the benefit of Prolaris in these patients, they should see growth in the platform. The big coups to come will be studies that correlate treatment outcomes with Prolaris score, since this information gives concrete guidance for doctors when selecting treatment. For this reason, the "active surveillance" study might be the most important for the bottom line, as it provides useful information that affects treatment decisions.

Prolaris will be one product to keep an eye on as part of your due diligence for MYGN.

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Myriad Genetics Makes A Strong Case For Its Prolaris Test - Seeking Alpha

Kirsten Bonawitz

Hometown: Stevensville, Michigan Major: Neuroscience Minors: Biology, Chemistry Clubs/Organizations: The Community Empowerment Fund, Duke Emergency Medical Services volunteer, On Tap, Alpha Phi Omega, Bass Connections Student Advisory Council, Neurogenesis Journal publishing editor Any other Activities You Participated In: Research in the Chiba-Falek lab What Duke has meant to you: Life-long friendships and endless opportunities.

Helping people is genuinely part of Kirsten Bonawitzs nature. Through the Bass Connections follow-on grant she received, Kirsten worked on elucidating the role of genetics in the development of late-onset Alzheimers disease. I think I was really drawn by the emotional component that drives this kind of research because in the end, the main goal is to help people who suffer from devastating diseases such as Alzheimers, said Kirsten.

Get complete information about the history, events and schedule for all of graduation weekend at the commencement website.

During Kirstens research, she collected neurons from normal and mild-cognitive impairment human brain samples, extracted RNA for the purpose of gene expression analysis and initiated the collection of neurons from mild and severe Alzheimers samples. This approach will aid in determining at which point in disease progression and within which specific cells gene expression changes occur, explained Kirsten. This project plays and will continue to play an important role in my academic and professional career, she said.

Kirsten also served as a volunteer for Duke Emergency Medical Services. She is one of four pre-med students credited with saving a popular Duke professors life after he had a heart attack in Perkins Library in fall of 2015. Kirsten and the other EMS student volunteers resuscitated professor George Grody, who suffered from cardiac arrest. After graduating, Kirsten will work as a medical fellow in Guatemala with The Global Public Service Academies. She also plans to apply to medical school.

Read more about Kirsten.

Read more:
Kirsten Bonawitz: Drawn to Genetics and Alzheimer's Disease Research - Duke Today

Most cases of Moebius syndrome are spontaneous, with no family history and no known genetic cause. In certain rare cases, the disorder has been associated with defects in chromosomes 3, 10, and 13. The Online Mendelian Inheritance in Man (OMIM) database lists the gene map locus 13q12.2-q13 as having significance for Moebius syndrome.

Mutations of the genes PLXND1 and REV3L have also been pinpointed as being associated with Moebius syndrome, based on animal studies showing nerve deficits typical of the syndrome when mutations of those genes are introduced in animals.

The significance of the genes PLXND1 and REV3L is as yet unknown, and their involvement sheds little light on the origins of the disease, since they regulate different pathways. PLXND1 is connected to neural migration during hindbrain development and REV3L plays a role in DNA translesion synthesis, a process which repairs damaged DNA.

PLXND1 has been mapped to chromosome 3q22.1. A novel mutation of PLXND1 was found in a patient diagnosed with Moebius syndrome in 2015. Sequencing in 103 patients with Moebius syndrome identified one additional patient with a mutation of PLXND1.

Conflicting studies have mapped REV3L to 1p33-32 and chromosome 6q21. A variant of REV3L leading to decreased levels of the normal REV3L transcript was found in a patient diagnosed with Moebius syndrome in 2015. That same variant was found in sequencing studies in 6 other unrelated patients with Moebius syndrome. In another study 103 patients with Moebius syndrome were sequenced and 2 were identified with a new variant of the REV3L gene.

In rare cases where Moebius syndrome shows a familial inheritance pattern, it is inherited as an autosomal dominant trait. That means a single copy of the abnormal gene results in the manifestation of the disease and there is a 50% chance of passing it on to the offspring.

In one family, six people in two generations had palsy of cranial nerves VI and/or VII with skeletal or digital malformations. Nine others had digital anomalies without the cranial nerve involvement. Another family had three members with features of Moebius syndrome with mental retardation. However, these cases of inheritance are very rare.

Defects of chromosomes 1p34 and 13q13 were found in one family which had facial diplegia and flexion finger contractures in 7 members across 3 generations. In another case, a two-year-old girl with Moebius syndrome had a deletion of 13q12.2. These cases suggest that chromosome 13q12.2-q13 is of significance.

One boy with symptoms of Moebius syndrome had a reciprocal translocation on chromosomes 1 and 2. The locus a 1p22 was switched with 2q21.1.

In another case, Moebius syndrome with cleft palate, dextrocardia, mandibular hypoplasia, brain volume loss, and Poland syndrome was associated with another translocation involving 1p22. In that case, it was switched with 11p13. These cases may implicate 1p22 as a genetic cause of Moebius syndrome.

Thus genetic mutation, or a combination of one or more mutations and environmental factors, may cause a developmental defect of the hindbrain. This may occur through mechanisms such as disruption of blood flow to the brain during fetal development, leading to the manifestation of Moebius syndrome at birth.

Reviewed by Liji Thomas, MD

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Genetics and Inheritance of Moebius Syndrome - News-Medical.net

8 May 2017, 9:40 a.m.

Glenisa Angus Studs 2017 catalogue boasts 44 young black bulls that are the sons of 11 individual sires sourced from Australia and overseas

Top line-up: Aaron and Ced Wise, Glenisa Angus Stud, Glen Aplin with a group of youngsters destined for the annual Glenisa Angus Sale, on May 12. Photo: Kent Ward

Glenisa Angus Studs 2017 catalogue boasts 44 young black bulls that are the sons of 11 individual sires sourcedfrom Australia and overseas.

Eleven international, colonial and homebred sires feature in the annual sale, held at 1pm on May 12 at Glenisa,Glen Aplin, Queensland.

Vendors, Ced and Rowena Wise and family have been buoyed by client feedback and increaseddemand for their physical product due to the change of date at the 2016 sale.

Last year, bulls soldto areas of the tablelands between Glen Innes and Stanthorpe, all parts of the northern rivers ofNSWand as far north as central Queensland.

Sires represented include new global introductions in the form of Sydgen Black Pearl 2006, SChisum 6175, Sitz Upward 307R, Jindra Double Vision and Remitall H Rachis 21R.

Thesebulls are joined by outsourced introductions like DSK GDK Good Go G133, RaffDynamite G156, DSK RR Feel Good F36 (AI,ET) and Booroomooka Hyperno H605 (AI) alongwith the homebred retaineeS, Glenisa Felix F017 (AI, ET) and Frederick F009 (AI, ET).

All on offer have been vaccinated with three day, blooded with three germ, five in one and vibrio.The entire team has been semen tested and soundness evaluated and tested Pestivirus negative.

The bulls preparation is one of a silage diet for nearly three months. Theyhave current Angus Group Breedplan figures, scan data including live weight, scrotalmeasurements.

Run and grown out on local harder country, the bullsgut has been fully protectedwith a growing out period and they have been educated and handled and worked with dogs,horses and bikes.

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Global genetics - The Northern Daily Leader

NOAA is studying ways to make it easier to commercially harvest the sablefish, prized for its flavor and as a possible solution to a worldwide demand for seafood

PORT ORCHARD The dark-gray fish prized for its buttery flavor live deep in the ocean, so researchers keep their lab cold and dark to simulate ideal conditions for sablefish larvae.

A biologist shines his dim red headlamp and uses an ultrasound to scan the belly of an anesthetized sablefish about the length of his forearm to tell if its female and has eggs to collect. He gently squeezes out hundreds of tiny, translucent eggs into a glass beaker.

Once the eggs are fertilized externally, theyll grow in large indoor tanks and some in floating net pens in Puget Sound to be used for research.

At this federal marine research station near Seattle, scientists are studying sablefish genetics and investigating ways to make it easier and more efficient to commercially grow the fish.

It is part of a larger effort by the National Oceanic and Atmospheric Administration (NOAA) to support marine aquaculture as a solution to feed a growing demand worldwide for seafood.

People are consuming more fish than in previous decades, with average worldwide per capita consumption hitting 43 pounds a year, according to the Food and Agriculture Organization of the United Nations. Fish consumption is expected to grow more in coming years.

NOAA says aquaculture can relieve pressure on fishing populations and promote economic growth.

Fishermen along the West Coast, mostly in Alaska, catch millions of pounds of wild sablefish each year, but no commercial sablefish net-pen farming exists in the U.S.

Sablefish, also known as black cod or butterfish, are a long-lived species native to the northeast Pacific Ocean and highly valued in Asia for its beneficial nutrients and delicate flavor. The fish is grilled, smoked, poached, roasted or served as sushi.

Michael Rubino, who directs the NOAA aquaculture program, noted that practices for farming fish in the United States meet very strict environmental regulations.

But some critics worry large-scale farms could harm wild fish stocks and ocean health, and some commercial fishermen worry about potential competition.

This would be a big threat for us, said Robert Alverson, executive director of the Fishing Vessel Owners Association, a Seattle-based group that represents about 95 commercial fishermen in Alaska, Oregon, Washington and California.

In 2015, fisherman harvested about 35 million pounds of sablefish worth $113 million in the United States, all along the West Coast.

Nearly half of the sablefish caught in the United States is exported, with a majority going to Japan.

Alaska prohibits finfish farming.

Rubino and others say wild harvests and aquaculture can complement each other, particularly during months when there are lower catch limits for wild sablefish.

In recent years, NOAA scientists have worked to reduce potential barriers to sablefish aquaculture. They have developed techniques to produce all-female stocks of sablefish that grow faster and much bigger than males in about 24 months. Ideal market size is roughly 5 pounds.

Theyve also studied different ways to reduce the costs of feeding juvenile fish, increase larvae survival rates and decrease deformities.

One research project is replacing more expensive algae with clay that is used to help sablefish larvae better find their prey. Another looked at finding the optimal temperature to increase larval growth.

Wild fish are caught off the Washington coast and used to develop captive brood stocks, or mature fish that are used for breeding.

At the facility, the fertilized eggs grow in silos in dark, cold rooms before being moved to other indoor tanks where theyre fed a steady diet of brined shrimp and other food. Large circular tanks hold fish in different growth stages.

The facility produces about 10,000 all-female fingerlings, or juveniles about an inch long, each year.

Kurt Grinnell, aquaculture manager for the Jamestown SKallam Tribe, said the tribe is very interested in sablefish aquaculture for many reasons.

Its a native fish to our area. Its a very robust fish. Its very sought-after. Its got great market value, he said. Over time, our country and other countries will have to get their protein source somewhere, and we believe this is one way to meet that demand.

Read more here:
Researchers seek better ways to farm sablefish - The Seattle Times